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.
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.
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There are 62 Locations for this study
Birmingham Alabama, 35209, United States
Encinitas California, 92024, United States
Pasadena California, 91105, United States
Rolling Hills Estates California, 90274, United States
Sacramento California, 95819, United States
San Diego California, 92123, United States
Santa Monica California, 90404, United States
Farmington Connecticut, 06032, United States
Clearwater Florida, 33756, United States
Jacksonville Florida, 32204, United States
Orange Park Florida, 32073, United States
Orange Park Florida, 32073, United States
Ormond Beach Florida, 32174, United States
Tampa Florida, 33624, United States
Newnan Georgia, 30263, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46256, United States
Indianapolis Indiana, 46256, United States
Plainfield Indiana, 46168, United States
Louisville Kentucky, 40241, United States
Lake Charles Louisiana, 70605, United States
Troy Michigan, 48084, United States
Saint Joseph Missouri, 64506, United States
Las Vegas Nevada, 89119, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Forest Hills New York, 11375, United States
New York New York, 10075, United States
Tulsa Oklahoma, 74136, United States
Hazleton Pennsylvania, 18201, United States
Pittsburgh Pennsylvania, 15213, United States
Johnston Rhode Island, 02919, United States
Rapid City South Dakota, 57702, United States
Bellaire Texas, 77401, United States
San Antonio Texas, 78218, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23233, United States
Phillip Australian Capital Territory, 2606, Australia
Sydney New South Wales, 2035, Australia
Benowa Queensland, 4217, Australia
Woolloongabba Queensland, 4102, Australia
East Melbourne Victoria, 3002, Australia
Parkville Victoria, 3050, Australia
Fremantle Western Australia, 6160, Australia
Hectorville, South Australia , 5073, Australia
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R3M 3, Canada
Markham Ontario, L3P 1, Canada
Oakville Ontario, L6J 7, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4B I, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 5, Canada
Montreal Quebec, H2K 4, Canada
Sherbrooke Quebec, J1H 1, Canada
Quebec , G1V 4, Canada
Berlin , 10789, Germany
Luebeck , 23538, Germany
Muenster , 48149, Germany
Tuebingen , 72076, Germany
Kecskemet , 6000, Hungary
Miskolc , 3529, Hungary
Szeged , 6720, Hungary
Szolnok , 5000, Hungary
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