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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03720470
Other study ID # B7451029
Secondary ID COMPARE2018-0025
Status Completed
Phase Phase 3
First received
Last updated
Start date October 29, 2018
Est. completion date March 6, 2020

Study information

Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 838
Est. completion date March 6, 2020
Est. primary completion date December 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female subjects aged 18 years or older at the time of informed consent - Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4) - Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease. - Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study - Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: 1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization; 2. Female subjects of childbearing potential 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. - Female subjects of non-childbearing potential must meet at least 1 of the following criteria: - Have undergone a documented hysterectomy and/or bilateral oophorectomy; - Have medically confirmed ovarian failure; or - 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. -If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study Exclusion Criteria: - 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 - Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study - Other active nonAD inflammatory skin diseases or conditions affecting skin - Prior treatment with JAK inhibitors - Previous treatment with dupilumab - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Study Design


Intervention

Drug:
PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.
Dupilumab
Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
Oral Placebo
Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20; In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.
Injectable Placebo
Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.

Locations

Country Name City State
Australia The Skin Centre Benowa Queensland
Australia Box Hill Hospital Box Hill Victoria
Australia Emeritus Research Camberwell Victoria
Australia Skin and Cancer Foundation Inc Carlton Victoria
Australia Sinclair Dermatology East Melbourne Victoria
Australia North Eastern Health Specialists Hectorville South Australia
Australia Australian Clinical Research Network Maroubra New South Wales
Australia Royal Melbourne Hospital Parkville Victoria
Australia Woden Dermatology Phillip Australian Capital Territory
Australia Veracity Clinical Research Pty Ltd Woolloongabba Queensland
Bulgaria "DCC Aleksandrovska" EOOD Sofia
Bulgaria "Mc Synexus Sofia" Eood Sofia
Bulgaria DCC 2/Sofia EOOD Sofia
Bulgaria Dermatology Clinic "Sofia" Ltd Sofia
Bulgaria Medical Centre Synexus Sofia EOOD-branch Stara Zagora Stara Zagora
Bulgaria "DCC "Mladost-M Varna" OOD Varna
Canada DermEffects London Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada Innovaderm Research Inc. Montréal Quebec
Canada North Bay Dermatology Centre North Bay Ontario
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Dr. Rachel Asiniwasis Medical Prof Corp Regina Saskatchewan
Canada AvantDerm Clinical Research Toronto Ontario
Canada Manna Research (Toronto) Toronto Ontario
Canada Toronto Research Centre Toronto Ontario
Canada Pacific Dermaesthetics Inc. Vancouver British Columbia
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
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 MIRES (M y F Estudios Clínicos Limitada) Santiago Región Metropolitana
Czechia Dermamedica S.R.O. Nachod
Czechia CCR Ostrava, s.r.o. Ostrava
Czechia BENU Lekarna Pardubice
Czechia CCR Czech, a.s. Pardubice
Czechia Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie Pardubice
Czechia Sanatorium profesora Arenbergera Praha 1
Czechia Lekarna U sv. Ignace Praha 2
Czechia Synexus Czech, s.r.o. Praha 2
Czechia CCR Prague, s.r.o. Praha 3
Germany Licca Clinical Research Institute Augsburg
Germany Fachklinik Bad Bentheim Bad Bentheim
Germany Klinikum Bielefeld Rosenhohe Bielefeld
Germany Universitätsklinikum Bonn AöR Bonn
Germany Klinische Forschung Dresden GmbH Dresden
Germany Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden Dresden
Germany IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung Frankfurt
Germany Universitätsklinikum und Poliklinik für Dermatologie und Venerologie Halle
Germany Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Studienzentrum Dr. med. Beate Schwarz Langenau
Germany SIBAmed Studienzentrum GmbH & Co KG Leipzig
Germany Universitaetsklinikum Schleswig-Holstein/Campus Luebeck Luebeck
Germany Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling Mahlow
Germany Universitätsklinikum Marburg Marburg
Germany University of Muenster Muenster
Hungary SE AOK Bor-, Nemikortani es Boronkologiai Klinika Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS Gyula
Hungary Trial Pharma Kft. Püspökladány
Hungary Medmare Bt Veszprem
Italy AOU Policlinico di Modena, Struttura Complessa di Dermatologia Modena
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore Roma RM
Japan Iidabashi Skin Clinic Chiyoda-ku Tokyo
Japan Fukuwa Clinic Chuo-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 Takagi Dermatological Clinic Obihiro Hokkaido
Japan Sanrui Hifuka Saitama
Japan Kume Clinic Sakai Osaka
Japan Tokyo Medical University Hospital Shinjyuku-ku Tokyo
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 Chungnam National University Hospital CNUH Daejeon
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 Severance Hospital, Yonsei Univ. Health System 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 Riga 1st Hospital, Clinic for Dermatology and STD Riga
Latvia Outpatient Clinic of Ventspils Ventspils
Mexico Arke Estudios Clinicos S.A. de C.V. Cuauhtemoc Mexico CITY
Mexico Cryptex Investigación Clínica, S.A. de C.V. Cuauhtemoc Mexico CITY
Mexico Eukarya Pharmasite S.C. Monterrey Nuevo LEON
Mexico SMIQ. S. de R. L. de C.V. Queretaro
Poland NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL" Bialystok
Poland Centrum Medyczne SENSEMED Chorzow
Poland Synexus Polska Sp. z o.o. Oddzial w Czestochowie Czestochowa
Poland COPERNICUS-SZPITAL Oddzial Dermatologii 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 Synexus Polska Sp. z o.o. Oddzial w Katowicach Katowice
Poland Gabinet Dermatologiczny Beata Krecisz Kielce
Poland AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc Krakow
Poland Centrum Medyczne Plejady Krakow
Poland Centrum Medyczne Promed Krakow
Poland Krakowskie Centrum Medyczne Sp. z o.o. Krakow
Poland Prywatna Praktyka Lekarska - Adam Smialowski Ksawerow
Poland Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak Lodz
Poland Salve Medica Sp. z o.o. Sp. k. 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 Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k. 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 Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland "REUMATIKA - Centrum Reumatologii" NZOZ Warszawa
Poland Carpe Diem Centrum Medycyny Estetycznej Warszawa
Poland Klinika Ambroziak Sp. z o.o. Warszawa
Poland Medycyna Kliniczna Warszawa
Poland MTZ Clinical Research Sp. z o.o. Warszawa
Poland RCMed Oddzial Warszawa Warszawa
Poland Synexus Polska Sp. z o.o. Oddzial w Warszawie 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
Slovakia SUMMIT CLINICAL RESEARCH, s.r.o. Bratislava
Slovakia Pedi-Derma s.r.o. Kosice
Slovakia Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica Kosice-Saca
Slovakia Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika Nove Zamky
Slovakia SANARE spol. s.r.o., Dermatovenerologicka ambulancia Svidnik
Spain Hospital Universitario Fundacion Alcorcon Alcorcon Madrid
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda Madrid
Spain Hospital Universitario y Politecnico La Fe Valencia
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Chung Shan Medical University Hospital (CSMUH) Taichung City
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)
United Kingdom MeDiNova Northamptonshire Dedicated Research Centre Corby
United Kingdom West Glasgow ACH, NHS Greater Glasgow and Clyde Glasgow
United Kingdom Medinova Research, Warwickshire Dedicated Research Centre Kenilworth Warwickshire
United Kingdom Guy's Hospital-Guy's and St Thomas NHS Foundation Trust London Greater London
United Kingdom MeDiNova Research North London Dedicated Research Centre Northwood Middlesex
United Kingdom Derriford Hospital Plymouth Devon
United Kingdom Medinova Research, East London Dedicated Research Centre Romford Essex
United Kingdom Medinova, Yorkshire Quality Research Site Shipley WEST Yorkshire
United Kingdom Medinova Research, South London Clinical Trial Centre Sidcup Kent
United Kingdom Medinova Research -West London Dedicated Research Centre Wokingham Berkshire
United Kingdom Medinova Research Yaxley Peterborough
United States Synexus Clinical Research US, Inc. Anderson South Carolina
United States Arlington Research Center, Inc. Arlington Texas
United States Austin Institute for Clinical Research, Inc. Austin Texas
United States Meridian Clinical Research, LLC Baton Rouge Louisiana
United States Clinical Research Center of Alabama, LLC Birmingham Alabama
United States The University Of Alabama At Birmingham Birmingham Alabama
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 IMMUNOe Research Centers Centennial Colorado
United States Great Lakes Clinical Trials Chicago Illinois
United States Portland Clinical Research dba Columbia Allergy & Asthma Clinic Clackamas Oregon
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Columbus Regional Research Institute Columbus Georgia
United States C & R Research Services USA, Inc Coral Gables Florida
United States Florida Academic Centers Research and Education, LLC Coral Gables Florida
United States Moonshine Research Center, Inc. Doral Florida
United States Idaho Allergy and Research Eagle Idaho
United States Medication Management, LLC Greensboro North Carolina
United States Synexus Clinical Research US. Inc. Greer South Carolina
United States Skin Laser and Surgery Specialists of NY and NJ Hackensack New Jersey
United States Center for Clinical Studies, LTD. LLP Houston Texas
United States Marvel Research, LLC Huntington Beach California
United States Solutions Through Advanced Research, Inc. Jacksonville Florida
United States Forest Hills Dermatology Group Kew Gardens New York
United States Alliance Research Centers Laguna Hills California
United States Olympian Clinical Research Largo Florida
United States Allergy & Asthma Care Center of Southern California Long Beach California
United States Forefront Dermatology, S.C. Louisville Kentucky
United States Crisor, LLC Medford Oregon
United States Savin Medical Group LLC Miami Florida
United States Wellness Clinical Research, LLC Miami Lakes Florida
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 Dermatology Specialists, Inc. Murrieta California
United States ASR, LLC Nampa Idaho
United States Juva Skin and Laser Center New York New York
United States Velocity Urgent Care Norfolk Virginia
United States Virginia Dermatology and Skin Cancer Center Norfolk Virginia
United States Midwest Allergy Sinus Asthma, SC Normal Illinois
United States TrialSpark, Inc (Russell Cohen) Oceanside New York
United States Newton Clinical Research Oklahoma City Oklahoma
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Oregon Health & Science University (OHSU) Portland Oregon
United States Health Concepts Rapid City South Dakota
United States MedDerm Associates San Diego California
United States Clinical Science Institute Santa Monica California
United States Synexus Clinical Research US, Inc. Santa Rosa California
United States NorthShore University HealthSystem Skokie Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare Statesville North Carolina
United States ForCare Clinical Research Tampa Florida
United States Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma
United States Center for Clinical Studies, LTD. LLP Webster Texas
United States Dundee Dermatology West Dundee Illinois
United States Jordan Valley Dermatology Center West Jordan Utah
United States Research Institute of Southeast, LLC West Palm Beach Florida
United States Research Institute of the Southeast, LLC West Palm Beach Florida
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,  Australia,  Bulgaria,  Canada,  Chile,  Czechia,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Poland,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole. Baseline (the last measurement prior to first dosing on Day 1), Week 12
Primary Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Week 12
Secondary Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Secondary Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. Baseline, Week 2, 4, 8 and 16
Secondary Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Week 2, 4, 8 and 16
Secondary Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Week 2, 4, 8, 12 and 16
Secondary Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Week 2, 4, 8,12 and 16
Secondary Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Week 2, 4, 8, 12 and 16
Secondary Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. Baseline up to Week 16
Secondary Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. Baseline, Week 2, 4, 8, 12 and 16
Secondary Percentage BSA at Week 18 and 20 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. Week 18 and 20
Secondary Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. Baseline, Week 2, 4, 8, 12 and 16
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. Baseline, Week 2, 12 and 16
Secondary DLQI at Week 20 DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. Week 20
Secondary Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. Baseline, Week 12 and 16
Secondary Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline, Week 12 and 16
Secondary EQ-5D-5L- Index Value at Week 20 EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. Week 20
Secondary EQ-5D-5L- VAS Score at Week 20 EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Week 20
Secondary Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. Baseline, Weeks 12 and 16
Secondary Change From Baseline in HADS - Depression Scale at Week 12 and 16 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. Baseline, Week 12 and 16
Secondary HADS - Anxiety Scale at Week 20 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. Week 20
Secondary HADS - Depression Scale at Week 20 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. Week 20
Secondary Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. Baseline, Week 12 and 16
Secondary POEM at Week 20 POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. Week 20
Secondary Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. Baseline, Week 1 to Week 16
Secondary PSAAD Total Score at Week 18 and 20 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. Week 18 and 20
Secondary Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. Baseline, Week 2, 4, 8 12 and 16
Secondary Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. Baseline, Week 2, 4, 8 12 and 16
Secondary Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. Baseline, Week 2, 4, 8 12 and 16
Secondary SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. Week 18 and 20
Secondary Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure. Baseline up to Week 16
See also
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