Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Vehicle (Placebo); Drug: PF-06700841

Study type: Interventional

Funder types: Industry

Identifiers

NCT03850483

B7931023

2018-003051-38 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.

Enrollment: 344 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• plaque psoriasis for 6 months
• PGA score mild or moderate
• body surface area (BSA) 2-15%

Exclusion criteria

• other skin conditions that would interfere with the evaluation of psoriasis
• history of herpes zoster or simplex
• Infected with Mycobacterium tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 9 patient groups, including a placebo group

Vehicle cream QD

Placebo Comparator group

Description:

Vehicle cream applied once daily (QD)

Treatment:

Drug: Vehicle (Placebo)

PF-06700841 0.1% cream QD

Experimental group

Description:

PF-06700841 0.1% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 0.3% cream QD

Experimental group

Description:

PF-06700841 0.3% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 1% cream QD

Experimental group

Description:

PF-06700841 1% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 3% cream QD

Experimental group

Description:

PF-06700841 3% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 0.3% cream BID

Experimental group

Description:

PF-06700841 0.3% cream applied twice daily (BID)

Treatment:

Drug: PF-06700841

PF-06700841 1% cream BID

Experimental group

Description:

PF-06700841 1% cream applied twice daily (BID)

Treatment:

Drug: PF-06700841

Vehicle cream BID

Placebo Comparator group

Description:

Vehicle cream applied twice daily (BID)

Treatment:

Drug: Vehicle (Placebo)

PF-06700841 3% cream BID

Experimental group

Description:

PF-06700841 3% cream applied twice daily (BID)

Treatment:

Drug: PF-06700841