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Topical Cream

Tapinarof Cream for Eczema

Phase 3

Waitlist Available

Research Sponsored by Dermavant Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Roll-over Subjects Only: Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study). Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only: Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD. Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old. Must not be pregnant at Screening or Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to each visit

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new cream for treating atopic dermatitis, a chronic skin condition. The trial will last up to 48 weeks and include follow-up appointments.

Who is the study for?

This trial is for individuals, including children as young as 2 years old, with atopic dermatitis (eczema). Participants must have had the condition for a minimum of 3 to 6 months depending on age. Women who can become pregnant must use birth control. Those previously in certain related studies or failing initial study criteria may also join.

What is being tested?

The trial tests Tapinarof cream, 1%, over up to 48 weeks to assess its long-term safety and effectiveness in treating atopic dermatitis. It's an open-label study where everyone receives the treatment and includes subjects from previous phase trials or new enrollees.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with topical treatments like Tapinarof cream could include skin irritation, redness, itching or burning sensation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 49

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 49

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 49 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in %BSA Affected

Change From Baseline in Eczema Area and Severity Index (EASI) Score

Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear )

+11 more

Secondary study objectives

Absolute value, change and percent change from Baseline in %BSA affected by visit

Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit

Mean change in PP- NRS score

+5 more

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT04042103

19%

Folliculitis

19%

Headache

10%

Back pain

10%

Pruritus

Chest Pain

Fatigue

Pain

pancreatitis

Abdominal Pain

Nausea

Pancreatitis

Furuncle

Diabetes mellitus

Nasopharyngitis

Dehydration

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Tapinarof (DMVT-505) Cream, 1%

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: tapinarof creamExperimental Treatment1 Intervention

Subjects entering with vIGA-AD (Validated Investigator Global Assessment of Atopic Dermatitis) ≥1 receive treatment with study drug until they achieve vIGA-AD=0, at which time treatment is discontinued and subjects are monitored for durability of response (remittive response). If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. Subjects entering with a vIGA-AD=0 discontinue treatment and are monitored for duration of remittive response. If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. This treatment and re-treatment pattern of use continue until the end of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tapinarof cream, 1%

2021

Completed Phase 3

~790

0 / 3Eligibility criteria met