Clinical trial NCT06493578: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.
Official title: A Randomized, Double-Blind, Vehicle-Controlled Phase 2b Trial Evaluating the Efficacy, Safety & Pharmacokinetics of VYN201 Gel in the Treatment of Non Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-segmental Vitiligo
Keywords: NSV
VYN201 Gel
vitiligo
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

1. Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures.
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 not exceed 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 the study completion. Over-the-counter preparations deemed acceptable by the investigator are permitted.
8. 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.
9. 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:

     1. Hormonal contraception (for at least 3 months prior to Screening) in combination 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).
10. Male participants, if not biologically or surgically sterilized, must agree not to donate sperm and, if engaging in sexual intercourse, must agree to use a condom from signing the ICF until at least 1 month after the last dose of study drug. If engaging with a female partner who could become pregnant, the female partner must additionally use an acceptable method of contraception for this same period.

Exclusion Criteria:

1. 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.).
2. Concomitant dermatologic conditions or other medical condition(s) which may, in the opinion 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 application site which, in the opinion of the investigator, will interfere with study assessments 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 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).
9. Major surgery within 3 months of randomization or with planned major surgery during trial.
10. Current or recent history (\<30 days before Screening and/or \<45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
11. 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).
12. 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.
13. 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.
14. Relevant (in the investigator opinion) ultraviolet light exposure including phototherapy within 8 weeks prior to Screening.
15. 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.
16. Known or suspected history of alcohol or drug abuse within 12 months of Screening or in the opinion of the investigator, will interfere with the subject's ability to comply with the administration schedule and study assessments (alcohol abuse is defined 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:

    1. Neutrophils \< lower limit of normal.
    2. Hemoglobin \< 10 g/dL.
    3. Platelets \< 100 × 109/L.
    4. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 × upper limit of normal.
    5. Estimated creatinine clearance \< 30 mL/min or renal disease requiring dialysis as determined by Cockcroft-Gault.
    6. Positive serology tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV)-1 and HIV-2 antibody.
19. Subjects who received a live vaccine within 4 weeks prior to Screening.
20. Subjects with known allergy or reaction to any component of the study formulation.

Primary outcomes:
measure: To evaluate the efficacy of VYN201 compared to vehicle at Week 24 in subjects with NSV.
timeFrame: Week 24
Secondary outcomes:
measure: To evaluate the efficacy of VYN201 as measured by F-VASI over time in subjects with NSV.
timeFrame: Week 24 and Week 52
measure: To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.
timeFrame: Week 52
Other outcomes:
measure: To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.
timeFrame: Week 24 and Week 52
measure: To evaluate the efficacy of VYN201 as measured by Vitiligo Noticeability Scale over time in subjects with NSV.
timeFrame: Week 52
measure: To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.
timeFrame: Week 24
measure: To evaluate the safety and tolerability of VYN201 as measured by Treatment-Emergent Adverse Events (TEAEs) over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To evaluate the safety and tolerability of VYN201 as measured by Physical Examinations over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To evaluate the safety and tolerability of VYN201 as measured by ECGs over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To evaluate the efficacy of VYN201 as measured by vital signs over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To evaluate the efficacy of VYN201 as measured by Laboratory Tests over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To evaluate the safety and tolerability of VYN201 as measured by Local Skin Tolerability assessment over time in subjects with NSV.
timeFrame: Baseline through Week 56
measure: To determine the PK of VYN201 in subjects with NSV (Dose Proportionality)
timeFrame: Week 24 and Week 52
measure: To determine the PK of VYN201 in subjects with NSV (Time to Steady State Ratio)
timeFrame: Week 24 and Week 52
measure: To determine the PK of VYN201 in subjects with NSV (Cmax)
timeFrame: Baseline through Week 52
measure: To determine the PK of VYN201 in subjects with NSV (Accumulation Ratio)
timeFrame: Week 24 and Week 52
measure: To determine the PK of VYN201 in subjects with NSV (Tmax)
timeFrame: Baseline through Week 52
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center
state: Alabama
city: Phoenix
country: United States
facility: Saguaro Dermatology
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT Research
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Fayetteville
country: United States
facility: Clinical Trial Institute of Northwest Arkansas, LLC
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research, Inc
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Castle Rock
country: United States
facility: Clarity Dermatology
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - FL LLC
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc
state: Florida
city: Chicago
country: United States
facility: MetroMed Clinical Trials
state: Illinois
city: Clarksville
country: United States
facility: DS Research of Southern Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: DelRicht Research at Audubon Dermatology
state: Louisiana
city: Rockville
country: United States
facility: Lawrence J. Green, MD LLC
state: Maryland
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: New City
country: United States
facility: The Skin Center Dermatology Group
state: New York
city: New York
country: United States
facility: Bobby Buka MD, PC
state: New York
city: Hickory
country: United States
facility: Hickory Dermatology Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center for Clinical Research
state: North Carolina
city: Canal Winchester
country: United States
facility: Clarity Dermatology
state: Ohio
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Hermitage
country: United States
facility: Cumberland Skin Center for Clinical Research
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: El Paso
country: United States
facility: Newco 3A Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Pflugerville
country: United States
facility: Austin Insitute for Clinical Research
state: Texas
city: Prosper
country: United States
facility: DelRicht Research at Lockhart Matter Dermatology
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Montréal
country: Canada
facility: Siena Medical Research
state: Quebec
Study officials:
References: