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Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Plaque Psoriasis

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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,...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • 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).

Key Trial Info

Start Date :

November 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT02201524

Start Date

November 1 2014

End Date

September 1 2015

Last Update

October 5 2016

Active Locations (45)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (45 locations)

1

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States, 32505

2

Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA

Rogers, Arkansas, United States, 72758

3

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

4

Dermatology Research Associates

Los Angeles, California, United States, 90045