A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.

NCT06493578 | Terminated Phase 2 FDA Drug

• 1 other identifier: VY2024-02
• Study Type: interventional
• Target: 205
• Locations: 2 countries
• Sites: 49

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of VYN201 Gel in subjects with non-segmental vitiligo.

Conditions

Non-segmental Vitiligo

Keywords

NSV; VYN201 Gel; vitiligo

Outcome Measures

Primary Outcomes (1)

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

  Proportion of subjects who achieve a ≥50% improvement from Baseline in F-VASI score at Week 24.

  Week 24

Secondary Outcomes (2)

• To evaluate the efficacy of VYN201 as measured by F-VASI over time in subjects with NSV.

  Week 24 and Week 52

• To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.

  Week 52

Other Outcomes (14)

• To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.

  Week 24 and Week 52

• To evaluate the efficacy of VYN201 as measured by Vitiligo Noticeability Scale over time in subjects with NSV.

  Week 52

• To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.

  Week 24

Study Arms (4)

Low dose VYN201 (1.0%)

ACTIVE COMPARATOR

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.

Drug: VYN201 Gel

Mid dose VYN201 (2.0%)

ACTIVE COMPARATOR

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.

Drug: VYN201 Gel

High dose VYN201 (3.0%)

ACTIVE COMPARATOR

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.

Drug: VYN201 Gel

Vehicle

PLACEBO COMPARATOR

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.

Drug: VYN201 Gel; Drug: Vehicle Gel

Interventions

VYN201 Gel DRUG

VYN201 Gel is a topical formulation applied as a thin layer to affected areas.

High dose VYN201 (3.0%); Low dose VYN201 (1.0%); Mid dose VYN201 (2.0%); Vehicle

Vehicle Gel DRUG

Vehicle gel (placebo) is matching in appearance to VYN201 gel and is to be applied in the same manner as VYN201 gel.

Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures.
• Able to understand and comply with study requirements.
• Male or female aged 18 to 75 years, inclusive.
• Clinical diagnosis of non-segmental vitiligo where the total affected BSA does not exceed 10%.
• F-VASI score of ≥0.5 and ≤3.0.
• T-VASI score of ≥3.0 and ≤10.0.
• Agree to discontinue all agents used to treat vitiligo from Screening through the study completion. Over-the-counter preparations deemed acceptable by the investigator are permitted.
• If receiving concomitant medication for any reason other than vitiligo, must be on a stable regimen at Screening, and anticipating staying on a stable regimen through the study completion.
• Female participants must:
• Be of non-childbearing potential (i.e., surgically sterilized \[hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal ligation/occlusion at least 6 weeks before the Screening\]) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause) OR
• If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the ICF until at least 1 month after the last dose of IMP. An acceptable method of contraception includes one of the following:
• Hormonal contraception (for at least 3 months prior to Screening) in combination with a barrier method.
• Intrauterine device (placement at least 3 months prior to Screening).
• Diaphragm with spermicide.
• Cervical cap with spermicide.

You may not qualify if:

• Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or de-pigmentation skin diseases (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy induced hypopigmentation, etc.).
• Concomitant dermatologic conditions or other medical condition(s) which may, in the opinion of the investigator, interfere with IMP application or study assessments.
• History of melanocyte transplantation procedure or depigmentation treatment \[e.g. Monobenzyl ether of hydroquinone (Monobenzone)\].
• Visible test site skin injury, damage, or observations in or around the application site which, in the opinion of the investigator, will interfere with study assessments or increase participation risk.
• 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.
• Leukotrichia in \>33% of vitiligo lesional surface of the face or the body.
• History or presence of any clinically significant condition(s) which, in the opinion of the investigator, could interfere with the course of the study or expose the participant to undue risk by participating in this study, including, but not limited to: metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, hematologic (including bleeding disorders), gastrointestinal (including peptic ulcer disease, gastritis or bleeding diathesis, excluding appendectomy or hernia repair), endocrine, immunologic, dermatologic, muscular, neurological, psychiatric, neoplastic, or other disease(s).
• Major surgery within 3 months of randomization or with planned major surgery during trial.
• Current or recent history (\<30 days before Screening and/or \<45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
• Any known or suspected premalignant or malignant disease within 5 years prior to Screening (excluding successfully treated basal or squamous cell carcinomas, actinic keratoses, melanoma in situ, cervical dysplasias, cervical cancer).
• Systemic biologic or immune-modulating treatment within 12 weeks prior to Screening and through study completion or topical treatment in the vitiligo areas within 2 weeks prior to Screening and through study completion.
• Received any investigational therapy, device or procedure within 30 days or 5 half-lives (whichever is longer) prior to Screening. Investigational biologics should be discussed with the sponsor to determine if a longer period of discontinuation is required.
• Relevant (in the investigator opinion) ultraviolet light exposure including phototherapy within 8 weeks prior to Screening.
• Use of any other prior and concomitant therapy not listed above that, in the opinion of the investigator, may interfere with the evaluation of study outcomes, including drugs that cause photosensitivity or skin pigmentation (e.g. antibiotics such as tetracyclines, antifungals). These medications should be discontinued within 4 weeks of randomization.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (49)

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

Location

Center for Dermatology and Plastic Surgery/CCT Research

Scottsdale, Arizona, 85260, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Clinical Trial Institute of Northwest Arkansas, LLC

Fayetteville, Arkansas, 72703, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology Research, Inc

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Clarity Dermatology

Castle Rock, Colorado, 80109, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Skin Care Research

Boca Raton, Florida, 33486, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Skin Care Research

Hollywood, Florida, 33021, United States

Location

International Clinical Research - FL LLC

Sanford, Florida, 32771, United States

Location

Metabolic Research Institute, Inc

West Palm Beach, Florida, 33401, United States

Location

MetroMed Clinical Trials

Chicago, Illinois, 60614, United States

Location

DS Research of Southern Indiana

Clarksville, Indiana, 47129, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

Location

DelRicht Research at Audubon Dermatology

New Orleans, Louisiana, 70115, United States

Location

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

The Skin Center Dermatology Group

New City, New York, 10956, United States

Location

Bobby Buka MD, PC

New York, New York, 10012, United States

Location

Hickory Dermatology Research Center

Hickory, North Carolina, 28602, United States

Location

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Clarity Dermatology

Canal Winchester, Ohio, 80109, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Cumberland Skin Center for Clinical Research

Hermitage, Tennessee, 37076, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Newco 3A Research

El Paso, Texas, 79902, United States

Location

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004, United States

Location

Austin Insitute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

DelRicht Research at Lockhart Matter Dermatology

Prosper, Texas, 75078, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

JRB Research Inc

Ottawa, Ontario, K1KL2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

Siena Medical Research

Montreal, Quebec, H3Z 2S6, Canada

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double-blind, vehicle-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: July 10, 2024
• Study Start: June 4, 2024
• Primary Completion: July 10, 2025
• Study Completion: September 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CA (7); US (42)