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Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

NCT04053387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 763

Last updated 2025-08-06

Study results available
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Summary

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Conditions

Interventions

DRUG

tapinarof cream, 1%

Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Victoria Butners · Dermavant Sciences GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2021-04-06
Completion
2021-04-06
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 NCT04053387 on ClinicalTrials.gov