Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT06648772
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.

Key Dates

Start date
Nov 14, 2024
Status verified
Oct 2024
Primary completion
Jun 28, 2025
Completion
Jul 4, 2025

Study Design

Enrollment
189 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast Cream 0.3%
    For topical use, Q.D.
  • Placebo Comparator: Vehicle cream
    For topical use, Q.D.

Primary Outcome Measure

Proportion of subjects achieving IGA treatment success after 8 weeks of treatment [ Time Frame: Baseline, week 8 ]

Central Contacts

Related Studies