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Topical Agent

Tapinarof Cream for Plaque Psoriasis

Phase 3
Recruiting
Research Sponsored by Dermavant Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
Be younger than 18 years old
Must not have
Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Current or chronic history of liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 and week 12
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new cream to see if it helps kids with plaque psoriasis.

Who is the study for?
This trial is for children and teens aged 2 to 17 with chronic plaque psoriasis covering at least 3% of their body. They must have had stable disease for the past three months, not be pregnant or immunocompromised, and have normal liver function tests. Girls who can get pregnant must use birth control.
What is being tested?
The study is testing tapinarof cream, a medication applied to the skin, in kids with plaque psoriasis. It's an open-label Phase 3 trial which means everyone knows they're getting tapinarof and it's being tested for safety and effectiveness.
What are the potential side effects?
While specific side effects are not listed here, common ones from topical treatments like creams may include skin irritation, redness, itching or burning at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My psoriasis covers 3% or more of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously participated in a study involving tapinarof.
Select...
I have a history of liver disease.
Select...
My psoriasis is not the plaque type.
Select...
I haven't had any cancer in the past 5 years, except for certain skin cancers or cervical pre-cancer.
Select...
My psoriasis spots show signs of infection.
Select...
I have not had major surgery in the last 8 weeks and do not plan to during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Secondary study objectives
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.

Side effects data

From 2021 Phase 3 trial • 763 Patients • NCT04053387
23%
Folliculitis
6%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tapinarof cream, 1%
2021
Completed Phase 3
~1580

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,921 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,810 Total Patients Enrolled

Media Library

Tapinarof (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05172726 — Phase 3
Plaque Psoriasis Research Study Groups: Open Label
Plaque Psoriasis Clinical Trial 2023: Tapinarof Highlights & Side Effects. Trial Name: NCT05172726 — Phase 3
Tapinarof (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172726 — Phase 3
~33 spots leftby May 2026
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