Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

NCT ID: NCT03627767

Last Updated: 2021-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2020-10-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04965842 100 mg QD

Double-blind randomized treatment following open label run-in period.

Group Type EXPERIMENTAL

PF-04965842 100 mg

Intervention Type DRUG

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

PF-04965842 200 mg QD

Double-blind randomized treatment following open label run-in period.

Group Type EXPERIMENTAL

PF-04965842 200 mg

Intervention Type DRUG

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

Placebo QD

Double-blind randomized treatment following open label run-in period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, administered as two tablets to be taken orally once daily for 40 weeks

Interventions

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PF-04965842 100 mg

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

Intervention Type DRUG

PF-04965842 200 mg

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

Intervention Type DRUG

Placebo

Placebo, administered as two tablets to be taken orally once daily for 40 weeks

Intervention Type DRUG

Other Intervention Names

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Abrocitinib Abrocitinib

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham, Dermatology at the Whitaker Clinic

Birmingham, Alabama, United States

Site Status

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Site Status

Tien Q Nguyen MD Inc dba First OC Dermatology

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Beach Allergy and Asthma Specialty Group, A Medical Corporation

Long Beach, California, United States

Site Status

Dermatology Specialists, Inc.

Oceanside, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

San Luis Dermatology and Laser Clinic

San Luis Obispo, California, United States

Site Status

Southern California Dermatology, Inc.

Santa Ana, California, United States

Site Status

Mosaic Dermatology

Santa Monica, California, United States

Site Status

Bay Pines VAHCS

Bay Pines, Florida, United States

Site Status

Skin Care Research, LLC

Boca Raton, Florida, United States

Site Status

Skin Research Institute

Coral Gables, Florida, United States

Site Status

Baumann Cosmetic and Research Institute

Miami, Florida, United States

Site Status

Park Avenue Dermatology

Orange Park, Florida, United States

Site Status

USF Asthma, Allergy & Immunology Clinical Research Unit

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Dermatologic Surgery Specialists, PC

Macon, Georgia, United States

Site Status

Midwest Allergy Sinus Asthma, SC

Normal, Illinois, United States

Site Status

NorthShore University HealthSystem Dermatology Clinical Trials Unit

Skokie, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Ds Research

New Albany, Indiana, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

Kansas City Dermatology, P.A.

Overland Park, Kansas, United States

Site Status

DXP Imaging

Louisville, Kentucky, United States

Site Status

Skin Sciences PLLC

Louisville, Kentucky, United States

Site Status

Qualmedica Research, LLC

Owensboro, Kentucky, United States

Site Status

Owensboro Dermatology Associates

Owensboro, Kentucky, United States

Site Status

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Saint Louis University Dermatology

St Louis, Missouri, United States

Site Status

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Site Status

Juva Skin and Laser Center

New York, New York, United States

Site Status

UR Dermatology at College Town

Rochester, New York, United States

Site Status

M3 - Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status

Bexley Dermatology Research

Bexley, Ohio, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Newton Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Dermatology Treatment & Research Center, PA

Dallas, Texas, United States

Site Status

Innovate Research, LLC

Fort Worth, Texas, United States

Site Status

The University of Texas Health Science Center Houston

Houston, Texas, United States

Site Status

Ventavia Research Group Hurst

Hurst, Texas, United States

Site Status

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Site Status

Dermatology Associates of Seattle

Seattle, Washington, United States

Site Status

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status

Framingham Centro Medico

La Plata, Buenos Aires, Argentina

Site Status

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status

Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC

Rosario, Santa Fe Province, Argentina

Site Status

CINME Centro de Investigaciones Metabolicas

C.a.b.a., , Argentina

Site Status

Buenos Aires Skin

C.a.b.a., , Argentina

Site Status

Psoriahue Medicina Interdisciplinaria

C.a.b.a, , Argentina

Site Status

University Hospital Brussels

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

University Hospital Antwerp

Edegem, , Belgium

Site Status

CETI - Centro de Estudos em Terapias Inovadoras LTDA.

Curitiba, Paraná, Brazil

Site Status

Instituto de Dermatologia e Estética do Brasil LTDA

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital De Clinicas De Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pesquisare Saude S/S Ltda

Santo André, São Paulo, Brazil

Site Status

Fundacao do ABC - Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status

IBPClin Pesquisa Clinica

Rio de Janeiro, , Brazil

Site Status

MC Asklepii" OOD

Dupnitsa, , Bulgaria

Site Status

MHAT "Dr. Tota Venkova" AD

Gabrovo, , Bulgaria

Site Status

"Center of skin-venereal diseases" EOOD, Sofia

Sofia, , Bulgaria

Site Status

"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD

Sofia, , Bulgaria

Site Status

"Mc Sinexus Sofia" Eood

Sofia, , Bulgaria

Site Status

ACIBADEM City Clinic Diagnostic-Consultative Center EOOD

Sofia, , Bulgaria

Site Status

"ACIBADEM City Clinic Medical Center Varna" EOOD

Varna, , Bulgaria

Site Status

Dermatology Research Institute

Calgary, Alberta, Canada

Site Status

Stratica Medical

Edmonton, Alberta, Canada

Site Status

Alberta Dermasurgery Center

Edmonton, Alberta, Canada

Site Status

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Site Status

Karma Clinical Trials, Inc.

St. John's, Newfoundland and Labrador, Canada

Site Status

CCA Medical Research

Ajax, Ontario, Canada

Site Status

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

DermEdge Research

Mississauga, Ontario, Canada

Site Status

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

Site Status

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

Site Status

Office of Dr. Paul Adam

Scarborough Village, Ontario, Canada

Site Status

AvantDerm

Toronto, Ontario, Canada

Site Status

K. Papp Clinical Research

Waterloo, Ontario, Canada

Site Status

XLR8 Medical Research Inc.

Windsor, Ontario, Canada

Site Status

Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

Québec, Quebec, Canada

Site Status

Centro Medico SkinMed Limitada

Santiago, Santiago Metropolitan, Chile

Site Status

Clinica Dermacross S.A.

Santiago, Santiago Metropolitan, Chile

Site Status

Hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Centro Internacional de Estudios Clinicos - CIEC

Santiago, Santiago Metropolitan, Chile

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

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Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

The First Affiliated Hospital With Nanjing University

Nanjing, Jiangsu, China

Site Status

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

Site Status

Jinan Central Hospital

Jinan, Shandong, China

Site Status

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Tianjin Medical University General Hospital, Dermatological Department

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept

Hangzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept

Hangzhou, Zhejiang, China

Site Status

Zhejiang Provincial People's Hospital/Dermatology Department

Hangzhou, Zhejiang, China

Site Status

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

Shanghai Changzheng Hospital

Shanghai, , China

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Shanghai Dermatology Hospital

Shanghai, , China

Site Status

Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie

Berlin, , Germany

Site Status

Hautzentrum Friedrichshain Studien

Berlin, , Germany

Site Status

Rothhaar Studien GmbH

Berlin, , Germany

Site Status

Klinikum Bielefeld Rosenhoehe

Bielefeld, , Germany

Site Status

Universitaetsklinikum Bonn

Bonn, , Germany

Site Status

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

Dresden, , Germany

Site Status

Universitaetsklinikum Erlangen

Erlangen, , Germany

Site Status

Universitaetsklinikum Essen

Essen, , Germany

Site Status

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Site Status

Universitätsklinikum und Poliklinik für Dermatologie und Venerologie

Halle, , Germany

Site Status

Klinische Forschung Hamburg GmbH

Hamburg, , Germany

Site Status

TFS Trial Form Support GmbH

Hamburg, , Germany

Site Status

Katholisches Kinderkrankenhaus Wilhemstift

Hamburg, , Germany

Site Status

MENSINGDERMA research GmbH

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Praxis Dr. med. Beate Schwarz

Langenau, , Germany

Site Status

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen

Stuttgart, , Germany

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Soroka University Medical Center

Beersheba, , Israel

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Rambam Health Care Campus

Haifa, , Israel

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Rabin Medical Center

Petah Tikva, , Israel

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The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

AOU Policlinico Sant'Orsola Malpighi

Bologna, BO, Italy

Site Status

Universita' degli Studi G. D'Annunzio -CeSi-MeT

Chieti, CH, Italy

Site Status

IFO Istituto Dermatologico San Gallicano IRCCS,

Roma, RM, Italy

Site Status

Ospedale Cristo Re

Roma, ROME, Italy

Site Status

Azienda Ospedaliero Universitaria San Martino di Genova

Genova, , Italy

Site Status

Ospedale Luigi Sacco

Milan, , Italy

Site Status

Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia

Modena, , Italy

Site Status

Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia

Rome, , Italy

Site Status

Riga 1st Hospital, Clinic of Dermatology and STD

Riga, , Latvia

Site Status

Health and Aesthetics Ltd

Riga, , Latvia

Site Status

Health Centre 4 Ltd, Dermatology Clinics

Riga, , Latvia

Site Status

Outpatient Clinic Of Ventspils

Ventspils, , Latvia

Site Status

Arke Estudios Clinicos S.A. de C.V.

Cuauhtémoc, Mexico City, Mexico

Site Status

JM Research SC

Cuernavaca, Morelos, Mexico

Site Status

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, Mexico

Site Status

Phylasis Clinicas Research S. de R.L. de C.V.

Cuautitlán Izcalli, State of Mexico, Mexico

Site Status

Derma Norte del Bajio S.C

Aguascalientes, , Mexico

Site Status

Centro de Investigacion Integral Medivest S.C.

Chihuahua City, , Mexico

Site Status

Universitair Medisch Centrum (UMC) Utrecht

Utrecht, , Netherlands

Site Status

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Site Status

Centrum Medyczne SENSEMED

Chorzów, , Poland

Site Status

Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii

Gdansk, , Poland

Site Status

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii

Gdansk, , Poland

Site Status

Silmedic Sp. z o.o., Oddzial w Katowicach

Katowice, , Poland

Site Status

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status

Pro Familia Altera Sp. z o.o.

Katowice, , Poland

Site Status

Malopolskie Centrum Kliniczne

Krakow, , Poland

Site Status

Centrum Badan Klinicznych JCI

Krakow, , Poland

Site Status

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, , Poland

Site Status

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, , Poland

Site Status

NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi

Lodz, , Poland

Site Status

O?rodek Bada? Klinicznych Appletreeclinics

Lodz, , Poland

Site Status

Dermoklinika-Centrum Medyczne s.c.

Lodz, , Poland

Site Status

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Site Status

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , Poland

Site Status

Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki

Szczecin, , Poland

Site Status

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, , Poland

Site Status

MTZ Clinical Research Sp. z o.o.

Warsaw, , Poland

Site Status

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

Warsaw, , Poland

Site Status

RCMed Oddzial Warszawa

Warsaw, , Poland

Site Status

Klinika Ambroziak Sp. z o.o.

Warsaw, , Poland

Site Status

ETG Warszawa

Warsaw, , Poland

Site Status

Wojskowy Instytut Medyczny, Klinika Dermatologiczna

Warsaw, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, , Poland

Site Status

Lukasz Matusiak "4Health'

Wroclaw, , Poland

Site Status

Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii

Zabrze, , Poland

Site Status

SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Brasov, JUD. Brasov, Romania

Site Status

Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan

Cluj-Napoca, JUD. CLUJ, Romania

Site Status

SC Delta Health Care SRL

Bucharest, , Romania

Site Status

SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"

Chelyabinsk, , Russia

Site Status

Limited Liability Company "Medical Center "Rheuma-Med"

Kemerovo, , Russia

Site Status

Clinic of FSBEI HE Kirov SMU MOH Russia

Kirov, , Russia

Site Status

FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF

Moscow, , Russia

Site Status

NRC Institute of Immunology FMBA of Russia

Moscow, , Russia

Site Status

SBI RR "Skin and Venereal Dispensary"

Rostov-on-Don, , Russia

Site Status

SBI RR "Regional Clinical Skin and Veneral Dispensary"

Ryazan, , Russia

Site Status

LLC "Pierre Wolkenstein Clinic of Skin Diseases"

Saint Petersburg, , Russia

Site Status

Vitiligo center

Saint Petersburg, , Russia

Site Status

SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"

Saint Petersburg, , Russia

Site Status

FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF

Saint Petersburg, , Russia

Site Status

Limited Liability Company "Sanavita"

Saint Petersburg, , Russia

Site Status

Medical Research Institute, LLC

Saint Petersburg, , Russia

Site Status

FSBEI HE I.P.Pavlov SPbSMU MOH Russia

Saint Petersburg, , Russia

Site Status

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, , Russia

Site Status

Military Medical Academy

Belgrade, , Serbia

Site Status

Clinical Centre Nis

Niš, , Serbia

Site Status

General Hospital Pancevo

Pančevo, , Serbia

Site Status

Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH

Bratislava, , Slovakia

Site Status

BeneDerma s.r.o.

Bratislava, , Slovakia

Site Status

Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia

Bratislava, , Slovakia

Site Status

Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia

Kosice-Saca, , Slovakia

Site Status

Pedi-Derma s.r.o., Dermatovenerologicka ambulancia

Košice, , Slovakia

Site Status

Derma-beauty, s.r.o., Dermatovenerologicka ambulancia

Nitra, , Slovakia

Site Status

SANARE spol. s.r.o., Dermatovenerologicka ambulancia

Svidník, , Slovakia

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Site Status

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital del Nino Jesus

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Site Status

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Taipei Medical University-Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital Linkou Branch

Taoyuan, , Taiwan

Site Status

Countries

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

References

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Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.

Reference Type DERIVED
PMID: 40028832 (View on PubMed)

Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.

Reference Type DERIVED
PMID: 38896380 (View on PubMed)

Flohr C, Cork MJ, Ardern-Jones MR, Eichenfield LF, Barbarot S, Feeney C, Rojo R, Lazariciu I, Nesnas J. Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial. J Dermatolog Treat. 2023 Dec;34(1):2200866. doi: 10.1080/09546634.2023.2200866.

Reference Type DERIVED
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Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.

Reference Type DERIVED
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Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18.

Reference Type DERIVED
PMID: 34406619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7451014

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Other Identifiers

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JADE REGIMEN

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000501-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REGIMEN

Identifier Type: OTHER

Identifier Source: secondary_id

B7451014

Identifier Type: -

Identifier Source: org_study_id

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