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Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1)

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ClinicalTrials.gov Identifier: NCT03349060
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety 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 of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: PF-04965842 100 mg Drug: PF-04965842 200 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: PF-04965842 100 mg Drug: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks

Experimental: PF-04965842 200 mg Drug: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 12 ]
    Response based on IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at Week 12

  2. Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 12 ]
    Response based on 75% improvement from baseline on EASI (EASI-75) at Week 12


Secondary Outcome Measures :
  1. Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Response based on at least 4 points improvement in severity of pruritus NRS from baseline at Weeks 2, 4 and 12

  2. Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PSAAD total score at Week 12

  3. Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 8, Week 16 (follow-up) ]
    Response based on at least 4 points improvement in severity of pruritus NRS from baseline at Weeks 8 and 16 (follow-up)

  4. Prutitus Numerical Rating Scale (NRS) [ Time Frame: Time from Baseline ]
    Time from baseline to achieve at least a 4 points improvement in the severity of pruritus NRS

  5. Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on 75% improvement from baseline in EASI (EASI-75) at Week 2, Week 4, Week 8, Week 16 (follow-up)

  6. Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on the IGA of clear (0) or almost clear (1) and >=2 point reduction from baseline at Week 2, Week 4, Week 8, Week 16 (follow-up)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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: BSA 10%, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349060


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Locations
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United States, Alabama
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35209
United States, California
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, United States, 92123
TCR Medical Corporation
San Diego, California, United States, 92123
Clinical Science Institute
Santa Monica, California, United States, 90404
United States, Florida
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States, 33134
Olympian Clinical Research
Largo, Florida, United States, 33770
Forward Clinical Trials, Inc.
Tampa, Florida, United States, 33624
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Illinois
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States, 60077
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States, 48202
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina Investigational Drug Service
Charleston, South Carolina, United States, 29425
MUSC SCTR Research Nexus Clinic and Laboratory
Charleston, South Carolina, United States, 29425
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
The University of Texas Health Science Center Houston
Houston, Texas, United States, 77030
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
United States, Washington
Pace Dermatology Associates
Lakewood, Washington, United States, 98499
MultiCare Allenmore Hospital
Tacoma, Washington, United States, 98405
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Pace Dermatology Associates
Tacoma, Washington, United States, 98405
Australia, New South Wales
Australian Clinical Research Network
Maroubra, New South Wales, Australia, 2035
Spectrum Medical Imaging
Maroubra, New South Wales, Australia, 2035
Australia, Queensland
Queensland X-Ray
Upper Mount Gravatt, Queensland, Australia, 4122
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Emeritus Research
Camberwell, Victoria, Australia, 3124
Skin and Cancer Foundation Inc
Carlton, Victoria, Australia, 3053
Sinclair Dermatology
East Melbourne, Victoria, Australia, 3002
The Royal Childrens Hospital
Parkville, Victoria, Australia, 3052
Bridge Road Imaging
Richmond, Victoria, Australia, 3121
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Mayfair Diagnostics
Calgary, Alberta, Canada, T3A 2N1
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A2N1
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc
Surrey, British Columbia, Canada, V3R 6A7
West Coast Medical Imaging Inc.
Surrey, British Columbia, Canada, V3R 6A7
University of British Columbia Department of Dermatology and Skin Science
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
Lynderm Research Inc
Markham, Ontario, Canada, L3P 1X2
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7
Research Toronto
Toronto, Ontario, Canada, M4W 2N2
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1L 0H8
Czechia
Lekarna Na Vaclavskem namesti
Kutna Hora, Czechia, 284 01
Kozni ambulance Kutna Hora, s.r.o.
Kutna Hora, Czechia, 28401
Lekarna Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Fakultni Nemocnice Ostrava, Kozni oddeleni
Ostrava - Poruba, Czechia, 70852
Sanatorium profesora Arenbergera
Praha 1, Czechia, 11000
Lekarna U sv. Ignace
Praha 2, Czechia, 120 00
Krajska zdravotni a.s.,Masarykova nemocnice o.z.
Usti nad Labem, Czechia, 40113
Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.
Usti nad Labem, Czechia
Germany
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
Luebeck, Schleswig-holstein, Germany, 23538
Fachklinik Bad Bentheim
Bad Bentheim, Germany, 48455
Charité - Universitaetsmedizin Berlin, CCM
Berlin, Germany, 10117
ISA - Interdisciplinary Study Association GmbH
Berlin, Germany, 10789
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, Germany, 01307
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Germany, 91054
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Ludwig-Maximilians-University Munich
Munich, Germany, 80337
Universitätsklinikum Münster
Münster, Germany, 48 149
Klinische Forschung Schwerin GmbH
Schwerin, Germany, 19055
Hungary
Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés
Kecskemet, Bács-kiskun, Hungary, 6000
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hungary, 4032
CRU Hungary Ltd.
Miskolc, Hungary, 3529
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika
Pecs, Hungary, 7632
Poland
MULTIKLINIKA Salute Sp. z o.o.
Katowice, Poland, 40-123
Silmedic Sp. z o.o., Oddzial w Katowicach
Katowice, Poland, 40-282
Centrum Medyczne Angelius Provita
Katowice, Poland, 40-611
Pro Familia Altera Sp. z o.o.
Katowice, Poland, 40-648
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Lodz, Poland, 90-265
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Poland, 90-436
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Poland, 27-400
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Warszawa, Poland, 04-141
United Kingdom
Derriford Hospital, Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom, PL6 8DH
Royal Free London NHS Foundation Trust
London, Greater London, United Kingdom, NW3 2QG
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, England, United Kingdom, S5 7AU
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2TH
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom, DY1 2HQ
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03349060     History of Changes
Other Study ID Numbers: B7451012
2017-003651-29 ( EudraCT Number )
MONO-1 ( Other Identifier: Alias Study Number )
JADE MONO-1 ( Other Identifier: Alias Study Number )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
atopic dermatitis
atopic eczema
eczema
JAK
janus kinase

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases