A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: PF-06826647; Drug: PF-06826647 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03895372

C2501004

2018-004669-16 (EudraCT Number)

Details and patient eligibility

About

This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.

Enrollment: 179 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female between the ages of 18 and 75 years.
• Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
• Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
• Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

Exclusion criteria

• Have non-plaque forms of psoriasis.
• Drug-induced psoriasis.
• Current active infection.
• Infected with Mycobacterium tuberculosis (TB).
• Have any history of malignancies.
• Require treatment with prohibited concomitant medications(s).
• Positive for hepatitis B or C, or human immunodeficiency virus (HIV).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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179 participants in 5 patient groups

PF-06826647 Drug Dose Level 1

Experimental group

Description:

Delivered orally for 16 weeks during the Investigational Treatment Period

Treatment:

Drug: PF-06826647 or Placebo

PF-06826647 Placebo

Experimental group

Description:

Delivered orally for 16 weeks during the Investigational Treatment Period

Treatment:

Drug: PF-06826647 or Placebo

PF-06826647 Drug Dose Level 2

Experimental group

Description:

Delivered orally for 16 weeks during the Investigational Treatment Period

Treatment:

Drug: PF-06826647 or Placebo

PF-06826647 Drug Dose Level 3

Experimental group

Description:

Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.

Treatment:

Drug: PF-06826647 or Placebo

Drug: PF-06826647

PF-06826647 Drug Dose Level 4

Experimental group

Description:

Delivered orally for 16 weeks then for 24 weeks in Extension Period.

Treatment:

Drug: PF-06826647 or Placebo

Drug: PF-06826647