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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03627767
Other study ID # B7451014
Secondary ID JADE REGIMEN2018
Status Completed
Phase Phase 3
First received
Last updated
Start date June 11, 2018
Est. completion date October 7, 2020

Study information

Verified date September 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.


Description:

Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.


Recruitment information / eligibility

Status Completed
Enrollment 1235
Est. completion date October 7, 2020
Est. primary completion date September 2, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - 12 years of age or older with a minimum body weight of 40 kg - Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4) - Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control Exclusion Criteria: - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study - Prior treatment with JAK inhibitors - Other active nonAD inflammatory skin diseases or conditions affecting skin - 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 - Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Study Design


Intervention

Drug:
PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
Placebo
Placebo, administered as two tablets to be taken orally once daily for 40 weeks

Locations

Country Name City State
Argentina Psoriahue Medicina Interdisciplinaria C.a.b.a
Argentina Buenos Aires Skin C.a.b.a.
Argentina CINME Centro de Investigaciones Metabolicas C.a.b.a.
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 Santa FE
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium University Hospital Brussels Brussels
Belgium University Hospital Antwerp Edegem
Brazil CETI - Centro de Estudos em Terapias Inovadoras LTDA. Curitiba PR
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 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
Bulgaria MC Asklepii" OOD Dupnitsa
Bulgaria MHAT "Dr. Tota Venkova" AD Gabrovo
Bulgaria "Center of skin-venereal diseases" EOOD, Sofia Sofia
Bulgaria "DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD Sofia
Bulgaria "Mc Sinexus Sofia" Eood Sofia
Bulgaria ACIBADEM City Clinic Diagnostic-Consultative Center EOOD Sofia
Bulgaria "ACIBADEM City Clinic Medical Center Varna" EOOD Varna
Canada CCA Medical Research Ajax Ontario
Canada SimcoDerm Medical and Surgical Dermatology Center Barrie Ontario
Canada Dermatology Research Institute Calgary Alberta
Canada Alberta Dermasurgery Center Edmonton Alberta
Canada Stratica Medical Edmonton Alberta
Canada Lynderm Research Inc. Markham Ontario
Canada DermEdge Research Mississauga 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 Office of Dr. Paul Adam Scarborough Ontario
Canada Karma Clinical Trials, Inc. St. John's Newfoundland and Labrador
Canada AvantDerm Toronto Ontario
Canada K. Papp Clinical Research Waterloo Ontario
Canada XLR8 Medical Research Inc. Windsor Ontario
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 Hospital Clinico Universidad de Chile Santiago Región Metropolitana
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Peking University First Hospital Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China The Second Affiliated Hospital of Army Medical University, PLA Chongqing Chongqing
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China The Third Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
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 Dermatology Hospital of Jiangxi Province Nanchang Jiangxi
China The First Affiliated Hospital With Nanjing University Nanjing Jiangsu
China Huashan Hospital Fudan University Shanghai Shanghai
China Shanghai Changzheng Hospital Shanghai
China Shanghai Dermatology Hospital 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
Germany Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie Berlin
Germany Hautzentrum Friedrichshain Studien Berlin
Germany Rothhaar Studien GmbH Berlin
Germany Klinikum Bielefeld Rosenhoehe Bielefeld
Germany Universitaetsklinikum Bonn Bonn
Germany Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden Dresden
Germany Universitaetsklinikum Erlangen Erlangen
Germany Universitaetsklinikum Essen Essen
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Universitätsklinikum und Poliklinik für Dermatologie und Venerologie Halle
Germany Katholisches Kinderkrankenhaus Wilhemstift Hamburg
Germany Klinische Forschung Hamburg GmbH Hamburg
Germany MENSINGDERMA research GmbH Hamburg
Germany TFS Trial Form Support GmbH Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Praxis Dr. med. Beate Schwarz Langenau
Germany Universitaetsklinikum Schleswig-Holstein Luebeck
Germany Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen Stuttgart
Israel Soroka University Medical Center Beer Sheva
Israel Rambam Health Care Campus Haifa
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 Azienda Ospedaliero Universitaria San Martino di Genova Genova
Italy Ospedale Luigi Sacco Milano
Italy Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia Modena
Italy IFO Istituto Dermatologico San Gallicano IRCCS, Roma RM
Italy Ospedale Cristo Re Roma Rome
Italy Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia Rome
Latvia Health and Aesthetics Ltd Riga
Latvia Health Centre 4 Ltd, Dermatology Clinics 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 Arke Estudios Clinicos S.A. de C.V. Cuauhtemoc Ciudad DE Mexico
Mexico Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlan Izcalli Estado DE Mexico
Mexico JM Research SC Cuernavaca Morelos
Mexico Centro de Dermatologia de Monterrey Monterrey Nuevo LEON
Netherlands Universitair Medisch Centrum (UMC) Utrecht Utrecht
Poland Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz
Poland Centrum Medyczne SENSEMED Chorzow
Poland Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii Gdansk
Poland Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii Gdansk
Poland Centrum Medyczne Angelius Provita Katowice
Poland Pro Familia Altera Sp. z o.o. Katowice
Poland Silmedic Sp. z o.o., Oddzial w Katowicach Katowice
Poland Centrum Badan Klinicznych JCI Krakow
Poland Krakowskie Centrum Medyczne Sp. z o.o. Krakow
Poland Malopolskie Centrum Kliniczne Krakow
Poland Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz
Poland Dermoklinika-Centrum Medyczne s.c. Lodz
Poland NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi Lodz
Poland O?rodek Bada? Klinicznych Appletreeclinics Lodz
Poland KO-MED Centra Kliniczne Lublin II Lublin
Poland Dermedic Jacek Zdybski Ostrowiec Swietokrzyski
Poland Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki Szczecin
Poland Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie Warszawa
Poland ETG Warszawa Warszawa
Poland Klinika Ambroziak Sp. z o.o. 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 Wojskowy Instytut Medyczny, Klinika Dermatologiczna Warszawa
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 Bucuresti
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 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 Limited Liability Company "Sanavita" Saint-Petersburg
Russian Federation LLC "Pierre Wolkenstein Clinic of Skin Diseases" Saint-Petersburg
Russian Federation SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology" 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 Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica Banska Bystrica
Slovakia BeneDerma s.r.o. Bratislava
Slovakia Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia Bratislava
Slovakia Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH Bratislava
Slovakia Pedi-Derma s.r.o., Dermatovenerologicka ambulancia Kosice
Slovakia Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia Kosice-Saca
Slovakia Derma-beauty, s.r.o., Dermatovenerologicka ambulancia Nitra
Slovakia SANARE spol. s.r.o., Dermatovenerologicka ambulancia Svidnik
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 Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital Sant Joan de Deu Esplugues de Llobregat Barcelona
Spain Hospital del Nino Jesus Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda Madrid
Spain Hospital Universitario Virgen de la Macarena Sevilla
Spain Consorcio Hospital General Universitario de Valencia Valencia
Spain Hospital Universitario y Politecnico La Fe Valencia
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 City
Taiwan National Cheng-Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Memorial Hospital Linkou Branch Taoyuan City
United States Emory University Atlanta Georgia
United States Meridian Clinical Research, LLC Baton Rouge Louisiana
United States Bay Pines VAHCS Bay Pines Florida
United States Bexley Dermatology Research Bexley Ohio
United States Clinical Research Center of Alabama, LLC Birmingham Alabama
United States Total Skin and Beauty Dermatology Center, PC Birmingham Alabama
United States University of Alabama at Birmingham, Dermatology at the Whitaker Clinic Birmingham Alabama
United States Skin Care Research, LLC Boca Raton Florida
United States Tufts Medical Center Boston Massachusetts
United States Skin Research Institute Coral Gables Florida
United States Dermatology Treatment & Research Center, PA Dallas Texas
United States Innovate Research, LLC Fort Worth Texas
United States Tien Q Nguyen MD Inc dba First OC Dermatology Fountain Valley California
United States Center for Dermatology Clinical Research, Inc. Fremont California
United States The University of Texas Health Science Center Houston Houston Texas
United States Ventavia Research Group Hurst Hurst Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Forest Hills Dermatology Group Kew Gardens New York
United States Beach Allergy and Asthma Specialty Group, A Medical Corporation Long Beach California
United States DXP Imaging Louisville Kentucky
United States Skin Sciences PLLC Louisville Kentucky
United States Dermatologic Surgery Specialists, PC Macon Georgia
United States Baumann Cosmetic and Research Institute Miami Florida
United States Ds Research New Albany Indiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Juva Skin and Laser Center New York New York
United States Virginia Clinical Research, Inc 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 Park Avenue Dermatology Orange Park Florida
United States Kansas City Dermatology, P.A. Overland Park Kansas
United States Owensboro Dermatology Associates Owensboro Kentucky
United States Qualmedica Research, LLC Owensboro Kentucky
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States The Indiana Clinical Trials Center Plainfield Indiana
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 Mayo Clinic Rochester Minnesota
United States UR Dermatology at College Town Rochester New York
United States MediSearch Clinical Trials Saint Joseph Missouri
United States Saint Louis University Dermatology Saint Louis Missouri
United States University of California San Diego San Diego California
United States San Luis Dermatology and Laser Clinic San Luis Obispo California
United States Southern California Dermatology, Inc. Santa Ana California
United States Mosaic Dermatology Santa Monica California
United States Dermatology Associates of Seattle Seattle Washington
United States NorthShore University HealthSystem Dermatology Clinical Trials Unit Skokie Illinois
United States Dermatology Specialists of Spokane Spokane Washington
United States USF Asthma, Allergy & Immunology Clinical Research Unit Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Germany,  Israel,  Italy,  Latvia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Loss of Response: Double-blind (DB) Period Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe. From Day 1 of up to Week 40 of double blind period
Primary Time to Loss of Response: Double-blind Period Time (in days) to loss of response based on achieving IGA >=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification. From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)
Secondary Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period Time (in days) to loss of response based on achieving IGA >=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)
Secondary 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 Weeks 12, 16, 28, 40, and 52: Double-blind Period IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) was scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin] and lower limbs [l] [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); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period 4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Secondary Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were 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, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period 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-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, 16, 28, 40 and 52
Secondary Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period 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-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, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity. Baseline, Weeks 12, 16, 28, 40 and 52
Secondary Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period 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 [darker or lighter], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participants 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, Weeks 12, 16, 28, 40 and 52
See also
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