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VYN201 Gel for Vitiligo

Phase 2

Recruiting

Research Sponsored by Vyne Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Male or female aged 18 to 75 years, inclusive

Clinical diagnosis of non-segmental vitiligo where the total affected BSA does not exceed 10%

Must not have

Dyed hair in the treatment area that could interfere with any clinical assessments

Significant facial hair or are unable to maintain very short cropped facial hair (<5mm) during course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 and week 52

Summary

"This trial aims to see how well VYN201 Gel works, how safe it is, and how the body processes it in people with non-segmental vitiligo."

Who is the study for?

This trial is for individuals with non-segmental vitiligo, a condition where skin loses its pigment. Details about who can join or reasons why someone might not be eligible are not provided.

What is being tested?

The study is testing the effectiveness and safety of VYN201 Gel compared to a Vehicle Gel (a gel without the active drug) in treating non-segmental vitiligo. It also looks at how the body processes the gel.

What are the potential side effects?

Specific side effects of VYN201 Gel are not listed, but they may include typical reactions to topical treatments such as skin irritation, redness, itching, or swelling at the application site.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have vitiligo affecting less than 10% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hair in the treatment area is not dyed.

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I cannot keep my facial hair shorter than 5mm during the study.

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I have had treatments to change the color of my skin.

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More than a third of my vitiligo spots are white without any pigment.

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I am not pregnant or breastfeeding.

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I have not had major surgery in the last 3 months and do not plan any during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the efficacy of VYN201 compared to vehicle at Week 24 in subjects with NSV.

Secondary study objectives

To determine the PK of VYN201 in subjects with NSV (Accumulation Ratio)

To determine the PK of VYN201 in subjects with NSV (Cmax)

To determine the PK of VYN201 in subjects with NSV (Dose Proportionality)

+11 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Low dose VYN201 (1.0%)Active Control1 Intervention

Subjects will apply VYN201 1.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 1.0% will remain and continue on the same dose until Week 52.

Group II: Mid dose VYN201 (2.0%)Active Control1 Intervention

Subjects will apply VYN201 2.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 2.0% will remain and continue on the same dose until Week 52.

Group III: High dose VYN201 (3.0%)Active Control1 Intervention

Subjects will apply VYN201 3.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 3.0% will remain and continue on the same dose until Week 52.

Group IV: VehiclePlacebo Group2 Interventions

Subjects will apply VYN201 vehicle (placebo) once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to vehicle (placebo) will be re-randomized to 1 of the 3 higher VYN201 (active) dose groups (1.0%, 2.0% or 3.0% once daily) in a 1:1:1 ratio while maintaining the blind until Week 52.

0 / 8Eligibility criteria met