Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

— JADE EXTEND  

Official title:

A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422822
• Other study ID #: B7451015
• Secondary ID: 2017-004851-22JA
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 8, 2018
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.

The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to <18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3160
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.

2. Male or female subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.

3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

4. Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.

5. Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:

1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to allocation to treatment.

2. Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.

For Czech Republic only, 5 b. is revised and 5 c. is added to require:

Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.

c. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.

6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

2. Have medically confirmed ovarian failure; or

3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.

8. Must agree to avoid use of prohibited medications throughout the duration of the study. Exclusion Criteria

1. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

2. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.

3. Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

4. Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

5. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

There are also additional separate inclusion and exclusion criteria to assess eligibility specifically for the B7451015 MRI sub-study.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Abrocitinib 100 mg
In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
• Abrocitinib 200 mg
In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
• Placebo
For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
• Abrocitinib 100 mg
For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
• Abrocitinib 100 mg
In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
• Abrocitinib 200 mg
In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.

Locations

Country	Name	City	State
Argentina	CINME Centro de Investigaciones Metabolicas	C.a.b.a
Argentina	Psoriahue Medicina Interdisciplinaria	C.a.b.a.
Argentina	CONEXA Investigación Clínica S.A.	Caba	Buenos Aires
Argentina	CONEXA Investigación Clínica S.A.	Caba	Buenos Aires
Argentina	Framingham Centro Medico	La Plata	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC - Rosario	Rosario	Santa FE
Australia	The Skin Centre	Benowa	Queensland
Australia	Eastern Health - Box Hill Hospital	Box Hill	Victoria
Australia	Emeritus Research	Camberwell
Australia	North Eastern Health Specialists	Campbelltown	South Australia
Australia	Skin Health Institute Inc.	Carlton	Victoria
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	St George Dermatology & Skin Cancer Centre	Kogarah	New South Wales
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Royal Children's Hospital	Parkville	Victoria
Australia	Royal Melbourne Hospital	Parkville, VIC
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Royal North Shore Hospital	Saint Leonards NSW
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	The Skin Hospital	Westmead	New South Wales
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Belgium	University Hospital Brussels	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	University Hospital Antwerp	Edegem
Brazil	Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles	Porto Alegre	RS
Brazil	Hospital de Clinicas de Porto Alegre (HCPA)	Porto Alegre	RS
Brazil	IBPClin Pesquisa Clinica	Rio de Janeiro
Brazil	Instituto de Dermatologia e Estética do Brasil LTDA	Rio de Janeiro	RJ
Brazil	Fundacao do ABC - Faculdade de Medicina do ABC	Santo Andre	SP
Brazil	Pesquisare Saude S/S Ltda	Santo Andre	SP
Brazil	Tecnolab Medicina Diagnostica	Santo Andre	SP
Brazil	Tecnolab - Unidade Matriz	Sao Bernardo do Campo	SP
Bulgaria	MHAT Dobrich AD	Dobrich
Bulgaria	MC Asklepii" OOD	Dupnitsa
Bulgaria	MHAT ''Dr. Tota Venkova'' AD	Gabrovo
Bulgaria	"Acibadem City Clinic MHAT Tokuda" EAD	Sofia
Bulgaria	"DCC Aleksandrovska" EOOD	Sofia
Bulgaria	"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD	Sofia
Bulgaria	"Mc Synexus Sofia" Eood	Sofia
Bulgaria	ACIBADEM City Clinic Diagnostic-Consultative Center EOOD	Sofia
Bulgaria	Dermatology Clinic "Sofia" - group practice for specialized outpatient medical care	Sofia
Bulgaria	Military Medical Academy MHAT Sofia	Sofia
Bulgaria	Medical Center Synexus Sofia EOOD-branch Stara Zagora	Stara Zagora
Bulgaria	"ACIBADEM City Clinic Medical Center Varna" EOOD	Varna
Bulgaria	"DCC Mladost-M Varna" OOD	Varna
Canada	CCA Medical Research	Ajax	Ontario
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Clinique de Radiologie du Saguenay Enr.	Chicoutimi	Quebec
Canada	Intermed groupe santé	Chicoutimi	Quebec
Canada	Alberta Dermasurgery Centre	Edmonton	Alberta
Canada	Stratica Medical	Edmonton	Alberta
Canada	Kingsway Clinical Research	Etobicoke	Ontario
Canada	Derm Effects	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	The Centre for Clinical Trials	Oakville	Ontario
Canada	Oshawa Clinic Dermatology Trials	Oshawa	Ontario
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	CARE Clinic Ltd	Red Deer	Alberta
Canada	Dr. Rachel Asiniwasis, Medical Professional Corp.	Regina	Saskatchewan
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Karma Clinical Trials, Inc.	St. John's	Newfoundland and Labrador
Canada	Medicor Research Inc	Sudbury	Ontario
Canada	Sudbury Skin Clinique	Sudbury	Ontario
Canada	Dr. Chih-ho Hong Medical Inc	Surrey	British Columbia
Canada	AvantDerm	Toronto	Ontario
Canada	Manna Research Inc.(Toronto)	Toronto	Ontario
Canada	North York Research Inc.	Toronto	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
Canada	Pacific Dermaesthetics Inc.	Vancouver	British Columbia
Canada	University of British Columbia Department of Dermatology and Skin Science	Vancouver	British Columbia
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario
Canada	XLR8 Medical Research Inc.	Windsor	Ontario
Canada	XLR8 Medical Research Inc.	Windsor	Ontario
Canada	Winnipeg Clinic	Winnipeg	Manitoba
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Chile	CEC Spa	Santiago	Región Metropolitana
Chile	Centro Internacional de Estudios Clinicos - CIEC	Santiago	Region Metropolitana
Chile	Centro Medico SkinMed Limitada	Santiago	Region Metropolitana
Chile	Clinica Dermacross S.A.	Santiago	Region Metropolitana
Chile	Hospital Clinico Universidad de Chile	Santiago	Región Metropolitana
Chile	MIRES (M Y F Estudios Clínicos Limitada)	Santiago	Región Metropolitana
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The second Xiangya Hospital,Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University, Dermatological department	Changsha	Hunan
China	The Second Affiliated Hospital of Army Medical University,PLA	Chongqing
China	The First Affiliated Hospital Of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Hangzhou Third Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital/Dermatology Department	Hangzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Dermatology Hospital of Jiangxi Province	Nanchang	Jiangxi
China	The First Affiliated Hospital With Nanjing University	Nanjing	Jiangsu
China	Dermatology Department, Shanghai Changzheng Hospital	Shanghai
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology	Shanghai
China	The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital, Dermatological Department	Tianjin	Tianjin
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Czechia	Lekarna Pod Kankem	Kunta Hora
Czechia	Kozni ambulance Kutna Hora, s.r.o	Kutná Hora
Czechia	Dermamedica S.R.O.	Nachod
Czechia	Lekarna U Stribrneho orla (Pharmacy)	Nachod
Czechia	Apavar Lekarna	Ostrava
Czechia	CCR Ostrava, s.r.o.	Ostrava
Czechia	Lekarna Rezidence Nova Karolina	Ostrava
Czechia	Fakultni Nemocnice Ostrava, Kozni oddeleni	Ostrava - Poruba
Czechia	Lekarna Fakultni Nemocnice Ostrava	Ostrava - Poruba
Czechia	BENU Lekarna	Pardubice
Czechia	Lekarna, Nemocnice Pardubickeho kraje, a.s. , Pardubicka nemocnice	Pardubice
Czechia	Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice	Pardubice
Czechia	PRATIA Pardubice a.s.	Pardubice
Czechia	Lekarna U Spasitele	Praha
Czechia	Prof. MUDr.Petr Arenberger, DrSc. MBA	Praha 1
Czechia	Lekarna Pod Platany	Praha 10
Czechia	Lekarna Pod Platany (Pharmacy)	Praha 10
Czechia	CCR Prague, s.r.o.	Praha 3
Czechia	PRATIA Prague s.r.o.	Praha 3
Czechia	Dermatovenerologicka ambulance	Svitavy
Czechia	Lekarna na Hranicni (Pharmacy)	Svitavy
Czechia	Krajska zdravotni a.s., Masarykova nemocnice o.z.	Usti nad Labem
Czechia	Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.	Usti nad Labem
Finland	Terveystalo Tampere	Tampere
Finland	Mehiläinen Neo	Turku
Finland	Turun yliopistollinen keskussairaala	Turku
Germany	Dermazentrum Augsburg	Augsburg
Germany	Licca Clinical Research Institute	Augsburg
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Charite-Universitaetsmedizin Berlin	Berlin
Germany	Hautzentrum Friedrichshain Studien	Berlin
Germany	ISA GmbH	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Klinikum Bielefeld Rosenhoehe	Bielefeld
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden	Dresden
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	IKF Pneumologie GmbH & Co KG; Institut für klinische Forschung	Frankfurt
Germany	SRH Wald-Klinikum Gera GmbH	Gera
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	MENSINGDERMA research GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Praxis Dr. med. Beate Schwarz	Langenau
Germany	SIBAmed Studienzentrum GmbH	Leipzig
Germany	Velocity Clinical Research Germany GmbH	Leipzig
Germany	Velocity Clinical Research, Leipzig	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Luebeck	Luebeck
Germany	Dermatologische Gemeinschaftspraxis	Mahlow
Germany	Dermatologische Gemeinschaftspraxis Dres. Quist	Mainz
Germany	Universitätsklinikum Marburg	Marburg
Germany	University of Muenster	Muenster
Germany	Ludwig-Maximilians-University Munich	Munich
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Germany	Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen	Stuttgart
Hungary	Bp. Fováros XIX. Kerület Önkormányzat Kispesti Eü. Intézete	Budapest
Hungary	Clinexpert Kft.	Budapest
Hungary	SE AOK Bor, Nemikortani es Boronkologiai Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	CRU Hungary Kft.	Encs
Hungary	Bugát Pál Kórház, Borgyógyászati Szakrendelés	Gyöngyös
Hungary	Trial Pharma Kft.	Gyor
Hungary	Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS	Gyula
Hungary	Trial Pharma Kft.	Kaposvár
Hungary	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet	Miskolc
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika	Pecs
Hungary	Trial Pharma Kft.	Püspökladány
Hungary	Szegedi Tudomanyegyetem Szent-Györgyi Albert	Szeged
Hungary	ALLERGO-DERM BAKOS Kft.	Szolnok
Hungary	Medmare Bt	Veszprem
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rabin Medical Center	Petah Tikva
Israel	The Chaim Sheba Medical Center	Ramat-Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Italy	AOU Policlinico Sant'Orsola Malpighi	Bologna	BO
Italy	Universita degli Studi G. D'Annunzio -CeSi-MeT	Chieti	CH
Italy	Ospedale Policlinico San Martino	Genova	GE
Italy	Istituto Clinico Humanitas IRCSS - UOC di Dermatologia	Milan
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	AOU Policlinico di Modena Struttura complessa di Dermatologia	Modena	MO
Italy	IFO lstituto Dermatologico San Gallicano IRCCS	Roma
Italy	Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia	Rome
Japan	Iidabashi Skin Clinic	Chiyoda-ku	Tokyo
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Hoshikuma Dermatology·Allergy Clinic	Fukuoka
Japan	Matsuda Tomoko Dermatological Clinic	Fukuoka
Japan	Osaka Habikino Medical Center	Habikino	Osaka
Japan	Kawashima Dermatology Clinic	Ichikawa	Chiba
Japan	Noguchi Dermatology Clinic	Kamimashiki-gun	Kumamoto
Japan	Dermatology Shimizu Clinic	Kobe	Hyogo
Japan	Matsuyama Dermatology Clinic	Nakano-ku	Tokyo
Japan	Yoshioka Dermatology Clinic	Neyagawa	Osaka
Japan	Takagi Dermatological Clinic	Obihiro	Hokkaido
Japan	Takagi Dermatological Clinic Branch	Obihiro	Hokkaido
Japan	Takagi Dermatology	Obihiro-shi	Hokkaido
Japan	Sanrui Hifuka	Saitama
Japan	Dermatology and Ophthalmology Kume Clinic	Sakai	Osaka
Japan	Tokyo Medical University Hospital	Shinjyuku-ku	Tokyo
Japan	Queen's square Medical Facilities Queen's square Dermatology and Allergology	Yokohama	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital CNUH	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei Univ. Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Latvia	Aesthetic dermatology clinic of Prof. J. Kisis	Riga
Latvia	Childrens Clinical University Hospital State SLLC	Riga
Latvia	Health and Aesthetics Ltd	Riga
Latvia	Health Centre 4 Ltd, Dermatology Clinics	Riga
Latvia	Health Centre 4 Ltd. Diagnostics Centre	Riga
Latvia	Riga 1st Hospital, Clinic of Dermatology and STD	Riga
Latvia	Outpatient Clinic Of Ventspils	Ventspils
Mexico	Derma Norte del Bajio S.C.	Aguascalientes
Mexico	Centro de Investigacion Integral MEDIVEST, S.C.	Chihuahua
Mexico	Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)	Chihuahua,CHIHUAHUA
Mexico	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlan Izcalli
Mexico	JM Research SC	Cuernavaca	Morelos
Mexico	Hospital Infantil de Mexico Federico Gomez	Del. Cuauhtemoc	Ciudad DE Mexico
Mexico	Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan	Merida	Yucatan
Mexico	Unidad de Atención Médica e Investigación en Salud	Mérida	Yucatán
Mexico	Arke Estudios Clinicos Sa De Cv	Mexico city
Mexico	Cryptex Investigación Clínica, S.A. de C.V.	Mexico City
Mexico	Hospital de Jesus, I.A.P.	Mexico City
Mexico	Trials in Medicine S.C.	Mexico City
Mexico	Centro de Dermatologia de Monterrey	Monterrey	Nuevo LEON
Mexico	Eukarya Pharmasite S.C.	Monterrey
Mexico	SMIQ, S. de R. L. de C.V.	Queretaro
Mexico	Clinical Research Institute S.C.	Saltillo	Coahuila
Mexico	Sociedad de Metabolismo y Corazon S.C.	Veracruz
Netherlands	Universitair Medisch Centrum (UMC) Utrecht	Utrecht
Poland	KLIMED Marek Klimkiewicz	Bialystok
Poland	NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.	Bialystok
Poland	Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny	Bydgoszcz
Poland	DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska	Chorzow
Poland	Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Czestochowa
Poland	Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska	Gdansk
Poland	Szpital Sw. Wojciecha	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne Klinika Dermatologii, Wenerologii i Alergologii	Gdansk
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	MCBK	Grodzisk Mazowiecki
Poland	Care Clinic Centrum Medyczne	Katowice
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	MULTIKLINIKA Salute Sp. z o.o.	Katowice
Poland	Pro Familia Altera Sp. z o.o.	Katowice
Poland	Silmedic Sp. z o.o., Oddzial w Katowicach	Katowice
Poland	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice
Poland	Gabinet Dermatologiczny Beata Krecisz	Kielce
Poland	Gabinet Dermatologiczny Beata Krecisz	Kielce
Poland	AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc	Krakow
Poland	Centrum Badan Klinicznych JCI	Krakow
Poland	Centrum Medyczne Plejady	Krakow
Poland	Centrum Medyczne Promed	Krakow
Poland	Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o.o.	Krakow
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow
Poland	Malopolskie Centrum Kliniczne	Krakow
Poland	Prywatna Praktyka Lekarska - Adam Smialowski INTERMED KSAWEROW	Ksawerow
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz
Poland	Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi	Lodz
Poland	Osrodek badan klinicznych AppleTree Clinics	Lodz
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Poland	NZOZ "Med-Laser" Borzecki Spolka Jawna	Lublin
Poland	Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski
Poland	Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.	Poznan
Poland	Gabinety Lekarskie Rivermed	Poznan
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan
Poland	LIFT-MED Spolka Akcyjna	Rybnik
Poland	EMED Centrum Uslug Medycznych Ewa Smialek	Rzeszow
Poland	Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii	Rzeszow
Poland	Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic" S.C.	Szczecin
Poland	Twoja Przychodnia Szczecinskie Centrum Medyczne	Szczecin
Poland	Twoja Przychodnia Szczecinskie Centrum Medyczne	Szczecin
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow
Poland	Carpe Diem Centrum Medycyny Estetycznej	Warszawa
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie	Warszawa
Poland	Centrum Medyczne AMED	Warszawa
Poland	ETG Warszawa	Warszawa	Mazowieckie
Poland	ETG Warszawa	Warszawa
Poland	ETG Warszawa	Warszawa
Poland	Klinika Ambroziak Sp. z o.o.	Warszawa
Poland	MICS Centrum Medyczne Warszawa	Warszawa
Poland	MTZ Clinical Research Powered by Pratia	Warszawa
Poland	RCMed Oddzial Warszawa	Warszawa
Poland	REUMATIKA - "Centrum Reumatologii" NZOZ 2	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Wojskowy Instytut Medyczny, Klinika Dermatologiczna	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej	Wroclaw
Poland	Lukasz Matusiak "4Health"	Wroclaw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Poland	Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii	Zabrze
Romania	SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL	Brasov	JUD. Brasov
Romania	SC Delta Health Care SRL	Bucharest
Romania	Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan	Cluj-Napoca	Jud. Cluj
Russian Federation	SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"	Chelyabinsk
Russian Federation	Limited Liability Company "Medical Center "Rheuma-Med"	Kemerovo
Russian Federation	Clinic of FSBEI HE Kirov SMU MOH Russia	Kirov
Russian Federation	FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF	Moscow
Russian Federation	NRC Institute of Immunology FMBA of Russia	Moscow
Russian Federation	SBI RR "Skin and Venereal Dispensary"	Rostov-on-Don
Russian Federation	SBI RR "Regional Clinical Skin and Veneral Dispensary"	Ryazan
Russian Federation	Limited Liability Company "Sanavita"	Saint Petersburg
Russian Federation	"Medical Research Institute", LLC	Saint-Petersburg
Russian Federation	FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF	Saint-Petersburg
Russian Federation	FSBEI HE I.P.Pavlov SPbSMU MOH Russia	Saint-Petersburg
Russian Federation	LLC "Pierre Wolkenstein Clinic of Skin Diseases"	Saint-Petersburg
Russian Federation	Vitiligo center	Saint-Petersburg
Russian Federation	RSBIH "Smolensk Regional Clinical Hospital"	Smolensk
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Centre Nis	Nis
Serbia	General Hospital Pancevo	Pancevo
Slovakia	BeneDerma s.r.o.	Bratislava
Slovakia	Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia	Bratislava
Slovakia	Narodny ustav detskych chorob	Bratislava
Slovakia	SUMMIT CLINICAL RESEARCH, s.r.o., Ambulancia vnutorneho lekarstva	Bratislava
Slovakia	Summit Clinical Research, s.r.o.	Bratislava - Mestská Cast Nove Mesto
Slovakia	Summit Clinical Research, s.r.o.	Bratislava - Metska Cast Nove Mesto
Slovakia	SKINKLINIK s.r.o.	Bratislava- Mestská Cast Nové Mesto
Slovakia	Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia	Kosice-Saca
Slovakia	Derma-beauty, s.r.o., Dermatovenerologicka ambulancia	Nitra
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka klinika	Nove Zamky
Slovakia	SANARE spol.s.r.o.	Svidnik
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau Servicio de Dermatologia	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Barcelona
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria	LAS Palmas
Spain	Hospital del Nino Jesus	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda	Madrid
Spain	Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)	Pontevedra
Spain	Hospital de Montecelo	Pontevedra
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei	Taiwan (r.o.c)
Taiwan	Chang Gung Memorial Hospital Linkou Branch	Taoyuan City
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire
United Kingdom	MAC Clinical Research	Blackpool
United Kingdom	University Hospital Bristol NHS Foundation Trust	Bristol
United Kingdom	MAC Clinical Research	Cannock
United Kingdom	Accellacare Warwickshire	Coventry
United Kingdom	West Glasgow Ambulatory Care Hospital	Glasgow
United Kingdom	Guy's Hospital-Guy's and St Thomas NHS Foundation Trust	London
United Kingdom	Royal free London NHS Foundation Trust	London	Greater London
United Kingdom	MAC Clinical Research Ltd	Manchester
United Kingdom	Accellacare North London	Northwood	Middlesex
United Kingdom	Accellacare South London	Orpington
United Kingdom	MeDiNova South London Quality Research Site	Orpington	Kent
United Kingdom	Plymouth Hospitals NHS Trust, Derriford Hospital	Plymouth	Devon
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	South Yorkshire
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital	Sheffield	South Yorkshire
United Kingdom	Accellacare Yorkshire	Shipley
United Kingdom	Medinova Research	Wokingham	Berkshire
United Kingdom	MeDiNova West London Quality Research Sites	Wokingham	Berkshire
United States	Emmaus Research Center, Inc.	Anaheim	California
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Meridian Clinical Research, LLC	Baton Rouge	Louisiana
United States	The University of Texas Health Science Center Houston	Bellaire	Texas
United States	Dermatologists of Greater Columbus	Bexley	Ohio
United States	Clinical Research Center of Alabama, LLC	Birmingham	Alabama
United States	Clinical Research Center of Alabama, LLC	Birmingham	Alabama
United States	The University of Alabama at Birmingham, Department of Dermatology	Birmingham	Alabama
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	University of Alabama at Birmingham - Dermatology Research Clinic	Birmingham	Alabama
United States	University of Alabama at Birmingham Hospital Outreach Lab	Birmingham	Alabama
United States	Skin Care Research	Boca Raton	Florida
United States	Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	MetroBoston Clinical Partners, LLC	Brighton	Massachusetts
United States	Renaissance Research and Medical Group, Inc	Cape Coral	Florida
United States	Cary Dermatology Center, PA	Cary	North Carolina
United States	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina
United States	MUSC SCTR Research Nexus Clinic and Laboratory	Charleston	South Carolina
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	Portland Clinical Research dba Columbia Asthma & Allergy Clinic	Clackamas	Oregon
United States	Clarkston Skin Research	Clarkston	Michigan
United States	Ds Research	Clarksville	Indiana
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Colorado Springs Dermatology Clinic, PC	Colorado Springs	Colorado
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	IACT Health	Columbus	Georgia
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Skin Research Institute	Coral Gables	Florida
United States	Avant Research Associates LLC	Crowley	Louisiana
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan
United States	Moonshine Research Center, Inc.	Doral	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Onyx Clinical Research	Flint	Michigan
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	First OC Dermatology	Fountain Valley	California
United States	First OC Dermatology Research Inc	Fountain Valley	California
United States	Summit Clinical Research, LLC	Franklin	Virginia
United States	The Ohio State University Dermatology East	Gahanna	Ohio
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Homestead Research Institute	Homestead	Florida
United States	Center for Clinical Studies, LTD. LLP	Houston	Texas
United States	Marvel Research, LLC	Huntington Beach	California
United States	Ventavia Research Group	Hurst	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana
United States	Tilda Research Inc.	Irvine	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Solutions Through Advanced Research, Inc.	Jacksonville	Florida
United States	One Health Research Clinic	Johns Creek	Georgia
United States	C & R Research Services USA, Inc	Kendall	Florida
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Pace Dermatology Associates	Lakewood	Washington
United States	Beach Allergy and Asthma Specialty Group, A Medical Corporation	Long Beach	California
United States	Keck School of Medicine of University of Southern California	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Wallace Medical Group, Inc	Los Angeles	California
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Dermatologic Surgery Specialists, PC	Macon	Georgia
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Tanenbaum Dermatology Center	Memphis	Tennessee
United States	Baumann Cosmetic and Research Institute	Miami	Florida
United States	Ciocca Dermatology, PA	Miami	Florida
United States	Clinical Trials Solutions	Miami	Florida
United States	Global Health Clinical Trials Corp	Miami	Florida
United States	INTERMED Medical Research Center, Inc	Miami	Florida
United States	La Salud Research Clinic, Inc.	Miami	Florida
United States	Miami Dermatology & Laser Research, LLC	Miami	Florida
United States	Nicklaus Children's Hospital	Miami	Florida
United States	South Miami Medical & Research Group, Inc.	Miami	Florida
United States	Suncoast Research Associates	Miami	Florida
United States	Suncoast Research Associates	Miami	Florida
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	Wellness Clinical Research, LLC	Miami Lakes	Florida
United States	Children's Hospital of Wisconsin Investigational Drug Service	Milwaukee	Wisconsin
United States	Children's Hospital of Wisconsin Translational Research Unit	Milwaukee	Wisconsin
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Allergy & Asthma Associates of Southern California dba Southern California Research	Mission Viejo	California
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	ASR, LLC	Nampa	Idaho
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Forest Hills Dermatology Group	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	One Health Research Clinic	Norcross	Georgia
United States	Fort Norfolk Diagnostic Center	Norfolk	Virginia
United States	Virginia Clinical Research, Inc	Norfolk	Virginia
United States	Virginia Dermatology and Skin Cancer Center	Norfolk	Virginia
United States	Midwest Allergy Sinus Asthma, SC	Normal	Illinois
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Newton Clinical Research	Oklahoma City	Oklahoma
United States	Skin Specialists PC	Omaha	Nebraska
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Accel Research Sites - Nona Pediatric Center	Orlando	Florida
United States	Advent Health Orlando - Investigational Drug Services	Orlando	Florida
United States	AdventHealth Orlando	Orlando	Florida
United States	AdventHealth Pediatric Dermatology Orlando	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Outpatient Services Center - AdventHealth Orlando	Orlando	Florida
United States	Pediatric Outpatient Procedures and Sedation	Orlando	Florida
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Owensboro Dermatology Associates	Owensboro	Kentucky
United States	Qualmedica Research, LLC.	Owensboro	Kentucky
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Paddington Testing Co, Inc.	Philadelphia	Pennsylvania
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	M3-Wake Research, Inc.	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Investigational Drug Service	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UR Dermatology at College Town	Rochester	New York
United States	DermAssociates, LLC	Rockville	Maryland
United States	Peninsula Headlands LLC	Rolling Hills Estates	California
United States	UC Davis Health	Sacramento	California
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Olympian Clinical Research	Saint Petersburg	Florida
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	MedDerm Associates	San Diego	California
United States	University of California San Diego Dermatology	San Diego	California
United States	Synergy Dermatology	San Francisco	California
United States	San Luis Dermatology and Laser Clinic	San Luis Obispo	California
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Wolverine Clinical Trials, Llc	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Mosaic Dermatology	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	Carolina Research Center, Inc.	Shelby	North Carolina
United States	NorthShore University HealthSystem - Dermatology	Skokie	Illinois
United States	NorthShore University HealthSystem Dermatology Clinical Trials Unit	Skokie	Illinois
United States	The South Bend Clinic Center for Research	South Bend	Indiana
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Principle Research Solutions	Spokane	Washington
United States	MultiCare Allenmore Hospital	Tacoma	Washington
United States	Multicare Institute for Research and Innovation	Tacoma	Washington
United States	Pace Dermatology Associates	Tacoma	Washington
United States	Center for Clinical Studies	Tampa	Florida
United States	Clinical Research Trials of Florida	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc.	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	University of South Florida; Asthma, Allergy and Immunology Clinical Research Unit	Tampa	Florida
United States	Revival Research Institute, LLC	Troy	Michigan
United States	Somerset Skin Centre	Troy	Michigan
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Center for Clinical Studies, LTD.LLP	Webster	Texas
United States	Henry Ford Medical Center - Farmington Road	West Bloomfield	Michigan
United States	Dundee Dermatology	West Dundee	Illinois
United States	Integrated Clinical Research	West Palm Beach	Florida
United States	Chesapeake Clinical Research, Inc.	White Marsh	Maryland
United States	Accellacare - Wilmington	Wilmington	North Carolina
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	Winston-Salem Dermatology and Surgery Center, PLLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Finland,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events	The incidence of treatment emergent adverse events	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary	Serious adverse events and adverse events leading to discontinuation	The incidence of serious adverse events and adverse events leading to discontinuation	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary	Change from baseline in clinical laboratory values	Change from baseline in clinical laboratory values	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary	Change from baseline in electrocardiogram (ECG) measurements	Change from baseline in electrocardiogram (ECG) measurements	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary	Change from baseline in vital signs	Change from baseline in vital signs	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Investigator's Global Assessment (IGA)	Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at all scheduled time points	Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Secondary	Eczema Area and Severity Index (EASI)	Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Pruritus Numerical Rating Scale (NRS)	Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points	Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Secondary	Patient Global Assessment (PtGA)	Change from baseline of PtGA at all scheduled time points	Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Secondary	Body Surface Area (BSA) affected	Change from baseline in the percentage BSA affected at all scheduled time points	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)	Change from baseline in DLQI or CDLQI at all scheduled time points	Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Secondary	Patient Oriented Eczema Measure (POEM)	Change from baseline in POEM at all scheduled time points	Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Secondary	Hospital Anxiety and Depression Scale (HADS)	Change from baseline in HADS at all scheduled time points	Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary	EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)	Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points	Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Secondary	Steroid-Free Days	Number of steroid-free days will be assessed throughout the duration of the study.	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Serum Hs-CRP Levels	Serum Hs-CRP levels at all scheduled time points	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Change in height standard deviation score (SDS)	Change in height standard deviation score (SDS) at all scheduled time points	Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary	Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD	Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD	Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 years

External Links

•   To obtain contact information for a study center near you, click here.