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

Status:	Terminated
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - 65
Updated:	4/21/2016
Start Date:	November 2014
End Date:	September 2015

A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis

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.

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).

We found this trial at

sites

Clinical Science Institute

Santa Monica, California 90404

from

Santa Monica, CA