MedTrace Logo

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

NCT03956355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2025-06-12

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Conditions

Interventions

DRUG

Tapinarof

Tapinarof cream, 1%, applied once daily

DRUG

Vehicle Cream

Vehicle cream applied once daily

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Victoria Butners · Dermavant Sciences GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-05-26
Completion
2020-05-26
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956355 on ClinicalTrials.gov