A PHASE 2B DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM IN PARTICIPANTS WITH CHRONIC PLAQUE PSORIASIS

Phase 1

• Conditions: Plaque psoriasis (PsO); MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-003051-38-BG
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-31
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 75 years, inclusive
• Diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Day 1.
• Physician Global Assessment (PGA) score mild or moderate
• Body surface area (BSA) 2-15% (based on treatment eligible areas)

See section 5.1 of the Protocol for a full list of Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• non plaque forms of psoriasis
• other skin conditions that would interfere with the evaluation of psoriasis (eg eczema)
• History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 3 months prior to Day 1. History of infection requiring oral antimicrobial therapy within 2 weeks prior to Day 1.
• Infected with Mycobacterium tuberculosis (TB)

See section 5.2 of the Protocol for a full list of Exclusion Criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified