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Clinical Trial Details for JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis


Pfizer
NCT ID: NCT03796676
Last Updated: October 10, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 12 Years - 17 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Pfizer
  • Location: Not Provided

Official Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Purpose

This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD.

Eligibility

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

– Aged between 12 and to 17 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: BSA 10%, IGA 3, EASI 16, Pruritus NRS
severity 4)

Exclusion Criteria:

– Acute or chronic medical or laboratory abnormality that may increase the risk
associated with study participation

– 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 non-AD inflammatory skin diseases or conditions affecting skin

– Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
malignancies, current or history of certain infections, 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

Additional Information, Locations & Contacts

Sponsors & Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center

Pfizer

Please refer to this study by its ClinicalTrials.gov identifier: NCT03796676

Location

Contacts

Clinical Research Center of Alabama, LLC

Birmingham, Alabama 35244

United States

Center for Dermatology Clinical Research, Inc.

Fremont, California 94538

United States

Madera Family Medical Group

Madera, California 93637

United States

Allergy & Asthma Associates of Southern California dba Southern California Research

Mission Viejo, California 92691

United States

Choc Psf, Amc

Orange, California 92868

United States

UC Davis

Sacramento, California 95816

United States

UC Davis IDS Pharmacy

Sacramento, California 95817

United States

Synexus Clinical Research US, Inc.

Santa Rosa, California 95405

United States

Brandon Premier Health Care/Gulf Coast Research Group, LLC

Brandon, Florida 33510

United States

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida 33134

United States

Moonshine Research Center, Inc.

Doral, Florida 33166

United States

Power MD Clinical Research Institute

Hialeah, Florida 33012

United States

Homestead Research Institute

Homestead, Florida 33030

United States

Olympian Clinical Research

Largo, Florida 33770

United States

Global Health Clinical Trials Corp

Miami, Florida 33135

United States

La Salud Research Clinic, Inc.

Miami, Florida 33155

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

South Miami Medical & Research Group, Inc.

Miami, Florida 33155

United States

Ciocca Dermatology, PA

Miami, Florida 33173

United States

INTERMED Medical Research Center, Inc

Miami, Florida 33175

United States

Suncoast Research Associates

Miami, Florida 33184

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

AdventHealth Pediatric Dermatology Orlando

Orlando, Florida 32803

United States

AdventHealth Orlando - Investigational Drug Services

Orlando, Florida 32804

United States

Oupatient Service Center-AdventHealth Orlando

Orlando, Florida 32804

United States

Pediatric Outpatient Procedures and Sedation

Orlando, Florida 32804

United States

Clinical Associates of Orlando, LLC

Orlando, Florida 32806

United States

Accel Research Sites

Orlando, Florida 32819

United States

Accel Research Sites - Nona Pediatric Center

Orlando, Florida 32829

United States

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida 32174

United States

ForCare Clinical Research

Tampa, Florida 33613

United States

Columbus Regional Research Institute

Columbus, Georgia 31904

United States

Meridian Clinical Research, LLC

Savannah, Georgia 31406

United States

Advanced Clinical Research @ Treasure Valley Dermatology & Skin Cancer Center

Boise, Idaho 83713

United States

Christie Clinic, LLC

Champaign, Illinois 61820

United States

Midwest Allergy Sinus Asthma, SC

Normal, Illinois 61761

United States

NorthShore University HealthSystem Dermatology Clinical Trials Unit

Skokie, Illinois 60077

United States

Southern Illinois School of Medicine

Springfield, Illinois 62702

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

The South Bend Clinic Center for Research

South Bend, Indiana 46617

United States

Forefront Dermatology S.C.

Louisville, Kentucky 40202

United States

Institute for Asthma and Allergy

Chevy Chase, Maryland 20815

United States

DermAssociates, LLC

Rockville, Maryland 20850

United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland 21162

United States

Clarkston Skin Research

Clarkston, Michigan 48346

United States

Center for Outpatient Health

Saint Louis, Missouri 63108

United States

St. Louis Children's Hospital

Saint Louis, Missouri 63108

United States

St. Louis Children's Hospital

Saint Louis, Missouri 63110

United States

Washington University School of Medicine

Saint Louis, Missouri 63110

United States

Advanced Dermatology of the Midlands

Omaha, Nebraska 68144

United States

Clinical Research Consortium

Las Vegas, Nevada 89119

United States

JDR Dermatology Research

Las Vegas, Nevada 89148

United States

Skin Laser and Surgery Specialists of New York & New Jersey

Hackensack, New Jersey 07601

United States

DermResearch Center of New York, Inc.

Stony Brook, New York 11790

United States

Synexus Clinical Research US, Inc.

Cincinnati, Ohio 45236

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Synexus Clinical Research US, Inc.

Anderson, South Carolina 29621

United States

Synexus Clinical Research US, Inc.

Greer, South Carolina 29651

United States

Austin Institute for Clinical Research, Inc.

Austin, Texas 78705

United States

Stephen Miller, MD, PA

San Antonio, Texas 78249

United States

Center for Clinical Studies, LTD.LLP

Webster, Texas 77598

United States

Virginia Clinical Research, Inc

Norfolk, Virginia 23502

United States

West Virginia Research Institute

Morgantown, West Virginia 26505

United States

Children's Hospital of Wisconsin Investigational Drug Service

Milwaukee, Wisconsin 53226

United States

Children's Hospital of Wisconsin Translational Research Unit

Milwaukee, Wisconsin 53226

United States

Australian Clinical Research Network

Maroubra, New South Wales 2035

Australia

The Skin Hospital (Skin & Cancer Foundation Australia)

Westmead, New South Wales 2145

Australia

The Skin Centre

Benowa, Queensland 4217

Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland 4102

Australia

Sinclair Dermatology

East Melbourne, Victoria (vic) 3002

Australia

The Royal Children's Hospital

Parkville, Victoria 3052

Australia

Beijing United Family Hospital

Beijing, Beijing 100015

China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing 100050

China

The Third Xiangya Hospital of Central South University

Changsha, Hunan 410013

China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi 330000

China

Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin

Jinan, Shandong 250022

China

Hangzhou Third Hospital

Hangzhou, Zhejiang 310009

China

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

Hangzhou, Zhejiang 310009

China

Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology

Shanghai, 200092

China

Shanghai Dermatology Hospital

Shanghai, 200443

China

Lekarna Na Vaclavskem namesti

Kutna Hora, 284 01

Czechia

Kozni ambulance Kutna Hora, s.r.o

Kutna Hora, 28401

Czechia

Dermamedica S.R.O.

Nachod, 547 01

Czechia

Lekarna U Stribrneho orla (pharmacy)

Nachod, 547 01

Czechia

Oblastni nemocnice Nachod (x-ray)

Nachod, 547 01

Czechia

Fakultni nemocnice Kralovske Vinohrady

Praha 10, 100 34

Czechia

Sanatorium profesora Arenbergera

Praha 1, 11000

Czechia

Lekarna Cisarska (Pharmacy)

Praha 2, 120 00

Czechia

Lekarna U sv. Ignace

Praha 2, 120 00

Czechia

Synexus Czech S.R.O.

Praha 2, 120 00

Czechia

Mestska poliklinika Praha (x-ray)

Praha, 110 00

Czechia

Dermatologicka Ambulance

Svitavy, 568 02

Czechia

Lekarna na Hranicni (Pharmacy)

Svitavy, 56802

Czechia

Nemocnice Svitavy (x-ray)

Svitavy, 56825

Czechia

Universitaetsklinikum Bonn

Bonn, NRW 53105

Germany

Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH

Bad Bentheim, 48455

Germany

Universitaetsklinikum Bonn

Bonn, 53105

Germany

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

Dresden, 01307

Germany

MENSINGDERMA research GmbH

Hamburg, 22391

Germany

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105

Germany

Clinexpert Kft.

Budapest, 1033

Hungary

Bugát Pál Kórház, Bőrgyógyászati Szakrendelés

Gyöngyös, 3200

Hungary

Trial Pharma Kft.

Győr, 9026

Hungary

Trial Pharma Kft.

Kaposvár, 7400

Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet

Miskolc, 3526

Hungary

Trial Pharma Kft.

Püspökladány, 4150

Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, 6720

Hungary

MEDIPARS Kft.

Szekszárd, 7100

Hungary

Istituto Clinico Humanitas IRCSS - UOC di Dermatologia

Milano, 20089

Italy

Ospedale San Pietro Fatebenefratelli

Roma, 00189

Italy

Takagi Dermatological Clinic

Obihiro, Hokkaido 080-0013

Japan

Dermatology Shimizu Clinic

Kobe, Hyogo 657-0846

Japan

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto 861-3101

Japan

Yoshioka Dermatology Clinic

Neyagawa, Osaka 572-0838

Japan

Kume Clinic

Sakai, Osaka 593-8324

Japan

Fukuwa Clinic

Chuo-ku, Tokyo 103-0027

Japan

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, 814-0171

Japan

Matsuda Tomoko Dermatological Clinic

Fukuoka, 819-0167

Japan

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, LV-1003

Latvia

Outpatient Clinic Of Ventspils

Ventspils, LV-3601

Latvia

Trials in Medicine S.C.

Cuauhtemoc, Ciudad DE México 06700

Mexico

Clinical Research Institute Saltillo S.A. de C.V.

Saltillo, Coahuila 25020

Mexico

Centro para el desarrollo de la medicina y de asistencia médica Especializada S.C.

Culiacan, Sinaloa 80230

Mexico

Unidad de Atención Médica e Investigación en Salud

Merida, Yucatan 97000

Mexico

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Merida, Yucatan 97130

Mexico

Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)

Chihuahua, 31238

Mexico

Hospital de Jesus Nazareno

Mexico City, 06090

Mexico

Sociedad de Metabolismo y Corazón S.C.

Veracruz, 91900

Mexico

KLIMED Marek Klimkiewicz

Bialystok, 15-704

Poland

Centrum Medyczne Pratia Czestochowa

Czestochowa, 42-200

Poland

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"

Czestochowa, 42-217

Poland

Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska

Gdansk, 80-462

Poland

Centrum Medyczne Angelius Provita

Katowice, 40-611

Poland

Centrum medyczne PLEJADY

Krakow, 30-363

Poland

Krakowskie Centrum Medyczne

Krakow, 31-501

Poland

Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak

Lodz, 90-436

Poland

Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, 27-400

Poland

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

Poznan, 60-702

Poland

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

Warszawa, 01-192

Poland

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

Wroclaw, 50-381

Poland

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, LAS Palmas 35010

Spain

Hospital General Universitario de Alicante

Alicante, 03010

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital del Nino Jesus

Madrid, 28009

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Miguel Servet Consultas Externas Dermatología

Zaragoza, 50009

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

Chung Shan Medical University Hospital

Taichung City, South DIST 402

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire S75 2EP

United Kingdom