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

Last updated: September 16, 2024
Sponsor: Vyne Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Vitiligo

Treatment

Vehicle Gel

VYN201 Gel

Clinical Study ID

NCT06493578
VY2024-02
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has completed and signed an Informed Consent Form (ICF) prior to any study-relatedprocedures.

  2. Able to understand and comply with study requirements.

  3. Male or female aged 18 to 75 years, inclusive.

  4. Clinical diagnosis of non-segmental vitiligo where the total affected BSA does notexceed 10%.

  5. F-VASI score of ≥0.5 and ≤3.0.

  6. T-VASI score of ≥3.0 and ≤10.0.

  7. Agree to discontinue all agents used to treat vitiligo from Screening through thestudy completion. Over-the-counter preparations deemed acceptable by theinvestigator are permitted.

  8. If receiving concomitant medication for any reason other than vitiligo, must be on astable regimen at Screening, and anticipating staying on a stable regimen throughthe study completion.

  9. Female participants must:

  • Be of non-childbearing potential (i.e., surgically sterilized [hysterectomy,bilateral salpingectomy, bilateral oophorectomy, tubal ligation/occlusion atleast 6 weeks before the Screening]) or postmenopausal (where postmenopausal isdefined 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 tobecome pregnant and, if engaging in sexual intercourse with a male partner,must agree to use an acceptable method of contraception from signing the ICFuntil at least 1 month after the last dose of IMP. An acceptable method ofcontraception includes one of the following:

  1. Hormonal contraception (for at least 3 months prior to Screening) incombination with a barrier method.

  2. Intrauterine device (placement at least 3 months prior to Screening).

  3. Diaphragm with spermicide.

  4. Cervical cap with spermicide.

  5. Condoms with spermicide.

  6. Vasectomized partner (6 months minimum since vasectomy).

  7. Male participants, if not biologically or surgically sterilized, must agree not todonate sperm and, if engaging in sexual intercourse, must agree to use a condom fromsigning the ICF until at least 1 month after the last dose of study drug. Ifengaging with a female partner who could become pregnant, the female partner mustadditionally use an acceptable method of contraception for this same period.

Exclusion

Exclusion Criteria:

  1. Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- orde-pigmentation skin diseases (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Haradadisease, malignancy induced hypopigmentation, etc.).

  2. Concomitant dermatologic conditions or other medical condition(s) which may, in theopinion of the investigator, interfere with IMP application or study assessments.

  3. History of melanocyte transplantation procedure or depigmentation treatment [e.g.Monobenzyl ether of hydroquinone (Monobenzone)].

  4. Visible test site skin injury, damage, or observations in or around the applicationsite which, in the opinion of the investigator, will interfere with studyassessments or increase participation risk.

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

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

  7. Leukotrichia in >33% of vitiligo lesional surface of the face or the body.

  8. History or presence of any clinically significant condition(s) which, in the opinionof the investigator, could interfere with the course of the study or expose theparticipant to undue risk by participating in this study, including, but not limitedto: 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).

  9. Major surgery within 3 months of randomization or with planned major surgery duringtrial.

  10. Current or recent history (<30 days before Screening and/or <45 days beforerandomization) of a clinically meaningful bacterial, fungal, parasitic, ormycobacterial infection.

  11. Any known or suspected premalignant or malignant disease within 5 years prior toScreening (excluding successfully treated basal or squamous cell carcinomas, actinickeratoses, melanoma in situ, cervical dysplasias, cervical cancer).

  12. Systemic biologic or immune-modulating treatment within 12 weeks prior to Screeningand through study completion or topical treatment in the vitiligo areas within 2weeks prior to Screening and through study completion.

  13. Received any investigational therapy, device or procedure within 30 days or 5half-lives (whichever is longer) prior to Screening. Investigational biologicsshould be discussed with the sponsor to determine if a longer period ofdiscontinuation is required.

  14. Relevant (in the investigator opinion) ultraviolet light exposure includingphototherapy within 8 weeks prior to Screening.

  15. Use of any other prior and concomitant therapy not listed above that, in the opinionof the investigator, may interfere with the evaluation of study outcomes, includingdrugs that cause photosensitivity or skin pigmentation (e.g. antibiotics such astetracyclines, antifungals). These medications should be discontinued within 4 weeksof randomization.

  16. Known or suspected history of alcohol or drug abuse within 12 months of Screening orin the opinion of the investigator, will interfere with the subject's ability tocomply with the administration schedule and study assessments (alcohol abuse isdefined as regular consumption of >10 standard units of alcohol per week).

  17. Subjects who are pregnant or breastfeeding.

  18. Clinically significant abnormal laboratory values at Screening:

  19. Neutrophils < lower limit of normal.

  20. Hemoglobin < 10 g/dL.

  21. Platelets < 100 × 109/L.

  22. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 × upper limitof normal.

  23. Estimated creatinine clearance < 30 mL/min or renal disease requiring dialysisas determined by Cockcroft-Gault.

  24. Positive serology tests for Hepatitis B surface antigen (HBsAg), hepatitis Cvirus antibody (anti-HCV), or human immunodeficiency virus (HIV)-1 and HIV-2antibody.

  25. Subjects who received a live vaccine within 4 weeks prior to Screening.

  26. Subjects with known allergy or reaction to any component of the study formulation.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Vehicle Gel
Phase: 2
Study Start date:
June 04, 2024
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • JRB Research Inc

    Ottawa, Ontario K1KL2
    Canada

    Active - Recruiting

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Active - Recruiting

  • Siena Medical Research

    Montréal, Quebec H3Z 2S6
    Canada

    Active - Recruiting

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Saguaro Dermatology

    Phoenix, Arizona 85008
    United States

    Active - Recruiting

  • Center for Dermatology and Plastic Surgery/CCT Research

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Clinical Trial Institute of Northwest Arkansas, LLC

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Active - Recruiting

  • First OC Dermatology Research, Inc

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Center for Dermatology Clinical Research, Inc

    Fremont, California 94538
    United States

    Active - Recruiting

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Palmtree Clinical Research, Inc.

    Palm Springs, California 92262
    United States

    Active - Recruiting

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Colorado Medical Research Center

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • Skin Care Research

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Driven Research LLC

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Skin Care Research

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • International Clinical Research - FL LLC

    Sanford, Florida 32771
    United States

    Active - Recruiting

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • MetroMed Clinical Trials

    Chicago, Illinois 60614
    United States

    Active - Recruiting

  • DS Research of Southern Indiana

    Clarksville, Indiana 47129
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • DS Research of Kentucky

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • DelRicht Research at Audubon Dermatology

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Lawrence J. Green, MD LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • JDR Dermatology Research

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • The Skin Center Dermatology Group

    New City, New York 10956
    United States

    Active - Recruiting

  • Bobby Buka MD, PC

    New York, New York 10012
    United States

    Active - Recruiting

  • Hickory Dermatology Research Center

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • The Skin Surgery Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • DOCS Dermatology Research - Canal Winchester

    Canal Winchester, Ohio 43110
    United States

    Active - Recruiting

  • Clarity Dermatology

    Castle Rock, Ohio 80109
    United States

    Active - Recruiting

  • Central Sooner Research

    Oklahoma City, Oklahoma 73170
    United States

    Active - Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Cumberland Skin Center for Clinical Research

    Hermitage, Tennessee 37076
    United States

    Active - Recruiting

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Newco 3A Research

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Austin Insitute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • DelRicht Research at Lockhart Matter Dermatology

    Prosper, Texas 75078
    United States

    Active - Recruiting

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Active - Recruiting

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