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

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• tapinarof cream, 1% — DRUG
  Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score

Study Details

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.

Key Dates

Start date

Aug 13, 2019

Status verified

Aug 2022

Primary completion

Apr 6, 2021

Completion

Apr 6, 2021

Study Design

Enrollment

763 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tapinarof (DMVT-505) Cream Group
  Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA ≥ 1 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (remittive response). If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re initiated and continued until a PGA = 0 was achieved. Subjects entering with a PGA = 0 had treatment discontinued and were monitored for duration of remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re initiated and continued until a PGA = 0 was achieved. This treatment and re treatment pattern of use was continued until the end of the study

Primary Outcome Measure

Number of Subjects With Adverse Events and Serious Adverse Events [ Time Frame: Baseline to 44 weeks ]

Locations (85)

Find similar trials in Birmingham, AL

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