Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.

Key facts

Study ID

NCT02201524

Run by

Pfizer

People needed

59

Starts

2014-11-01

Expected to finish

2015-09-01

Last updated by the study team

2016-10-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
• Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
• Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
• Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

You may not qualify if…

• Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
• 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
• Have received any of the following treatment regimens specified in the timeframes outlined below:
• Within 9 months of first dose of study drug:
• Ustekinumab (Stelara).
• Within 12 weeks of first dose of study drug:
• Any experimental therapy for psoriasis or rheumatoid arthritis.
• Within 4 8 weeks of first dose of study drug:
• Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:
• 4 weeks: etanercept (Enbrel).
• 8 weeks: infliximab (Remicade), adalimumab (Humira).
• Within 4 weeks of first dose of study drug:
• Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).
• Phototherapy and psoralen plus ultraviolet A therapy (PUVA).
• Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.
• Within 2 weeks of first dose of study drug:
• Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).
• Phototherapy with ultraviolet B (UVB) (narrowband or broadband).

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA — Rogers, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• Huntington Medical Foundation/Specialty Office — Pasadena, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Westcoast Radiology Services — Clearwater, Florida, United States
• North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Park Avenue Dermatology, PA — Orange Park, Florida, United States
• Leavitt Medical Associates of Florida d/b/a Ameriderm Research — Ormond Beach, Florida, United States
• Advanced Medical Research, Inc — Atlanta, Georgia, United States
• Columbus Dermatology, P.C. — Columbus, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Shondra L Smith, MD — Lake Charles, Louisiana, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center - Section of Dermatology — Lebanon, New Hampshire, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center - Shipment Only — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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