Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
NCT02201524
ABOUT THIS STUDY
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Adult Trials: 18+ Years
1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
psoriasis.
2. 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.
3. 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).
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis | |||
| Official Title ICMJE | A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis | |||
| 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, 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Plaque Psoriasis | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 59 | |||
| Original Estimated Enrollment ICMJE | 196 | |||
| Actual Study Completion Date ICMJE | September 2015 | |||
| Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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:
Within 4 weeks of first dose of study drug:
Within 2 weeks of first dose of study drug:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02201524 | |||
| Other Study ID Numbers ICMJE | B7451005 JAK-1 FOR PSORIASIS ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||