Psoriasis Clinical Trial

Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Summary

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

Must have the following atopic dermatitis criteria:

Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

Exclusion Criteria:

History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
Infected with hepatitis B or hepatitis C viruses.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

269

Study ID:

NCT02780167

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 62 Locations for this study

See Locations Near You

Clinical Research Center of Alabama
Birmingham Alabama, 35209, United States
California Dermatology & Clinical Research Institute
Encinitas California, 92024, United States
Huntington Medical Foundation
Pasadena California, 91105, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates California, 90274, United States
Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery
Sacramento California, 95819, United States
TCR Medical Corporation
San Diego California, 92123, United States
Clinical Science Institute
Santa Monica California, 90404, United States
University of Connecticut Health Center (UConn Health)
Farmington Connecticut, 06032, United States
Olympian Clinical Research
Clearwater Florida, 33756, United States
North Florida Dermatology Associates, PA
Jacksonville Florida, 32204, United States
Park Avenue Dermatology Administration Annex
Orange Park Florida, 32073, United States
Park Avenue Dermatology
Orange Park Florida, 32073, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach Florida, 32174, United States
Forward Clinical Trials, Inc.
Tampa Florida, 33624, United States
MedaPhase, Inc.
Newnan Georgia, 30263, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46256, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis Indiana, 46256, United States
The Indiana Clinical Trials Center
Plainfield Indiana, 46168, United States
DS Research
Louisville Kentucky, 40241, United States
Shondra L Smith, MD Dermatology & Advanced Aesthetics
Lake Charles Louisiana, 70605, United States
Somerset Skin Centre
Troy Michigan, 48084, United States
MediSearch Clinical Trials
Saint Joseph Missouri, 64506, United States
Clinical Research Consortium
Las Vegas Nevada, 89119, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
The Dermatology Group, P.C
Verona New Jersey, 07044, United States
Forest Hills Dermatology Group
Forest Hills New York, 11375, United States
Sadick Research Group
New York New York, 10075, United States
Vital Prospects Clinical Research Institute, P.C
Tulsa Oklahoma, 74136, United States
DermDox Centers for Dermatology
Hazleton Pennsylvania, 18201, United States
UPMC Department of Dermatology
Pittsburgh Pennsylvania, 15213, United States
Clinical Partners, LLC
Johnston Rhode Island, 02919, United States
Health Concepts
Rapid City South Dakota, 57702, United States
Bellaire Dermatology Associates
Bellaire Texas, 77401, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Virginia Clinical Research,Inc
Norfolk Virginia, 23502, United States
West End Dermatology Associates
Richmond Virginia, 23233, United States
Woden Dermatology
Phillip Australian Capital Territory, 2606, Australia
Australian Clinical Research Network
Sydney New South Wales, 2035, Australia
The Skin Centre
Benowa Queensland, 4217, Australia
Veracity Clinical Research
Woolloongabba Queensland, 4102, Australia
Sinclair Dermatology
East Melbourne Victoria, 3002, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Fremantle Dermatology
Fremantle Western Australia, 6160, Australia
North Eastern Health Specialists
Hectorville, South Australia , 5073, Australia
University of British Columbia
Vancouver British Columbia, V5Z 4, Canada
Wiseman Dermatology Research Inc.
Winnipeg Manitoba, R3M 3, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
Research by ICLS
Oakville Ontario, L6J 7, Canada
Skin Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
The Centre for Dermatology
Richmond Hill Ontario, L4B I, Canada
K. Papp Clinical Research
Waterloo Ontario, N2J 1, Canada
Windsor Clinical Research Inc
Windsor Ontario, N8W 5, Canada
Innovaderm Research Inc.
Montreal Quebec, H2K 4, Canada
Diex Research Sherbrooke Inc.
Sherbrooke Quebec, J1H 1, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Quebec , G1V 4, Canada
ISA GmbH
Berlin , 10789, Germany
Universitaetsklinikum Schleswig-Holstein
Luebeck , 23538, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo
Kecskemet , 6000, Hungary
CRU Hungary Ltd., MISEK-CRU
Miskolc , 3529, Hungary
Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika
Szeged , 6720, Hungary
Allergo-Derm Bakos Kft.
Szolnok , 5000, Hungary

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

269

Study ID:

NCT02780167

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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