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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: PF-04965842; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201524

B7451005

JAK-1 FOR PSORIASIS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

200mg of PF-04965842 twice daily

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 2

Experimental group

Description:

400mg of PF-04965842 once daily

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 3

Experimental group

Description:

200mg of PF-04965842 once daily

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Drug: PF-04965842

Cohort 4

Placebo Comparator group

Description:

Placebo comparator daily

Treatment:

Other: Placebo