A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.
NCT Number: NCT06493578
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-segmental Vitiligo
Interventions: DRUG: VYN201 Gel|DRUG: Vehicle Gel
Sponsor: Vyne Therapeutics Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2026-01-30
Locations: Cahaba Dermatology & Skin Health Center, Birmingham, Alabama, 35244, United States|Center for Dermatology and Plastic Surgery/CCT Research, Scottsdale, Arizona, 85260, United States|Noble Clinical Research, Tucson, Arizona, 85704, United States|Burke Pharmaceutical Research, Hot Springs, Arkansas, 71913, United States|California Dermatology & Clinical Research Institute, Encinitas, California, 92024, United States|First OC Dermatology Research, Inc, Fountain Valley, California, 92708, United States|Center for Dermatology Clinical Research, Inc, Fremont, California, 94538, United States|Marvel Clinical Research, Huntington Beach, California, 92647, United States|Northridge Clinical Trials, Northridge, California, 91325, United States|Integrative Skin Science and Research, Sacramento, California, 95815, United States|Colorado Medical Research Center, Denver, Colorado, 80210, United States|Skin Care Research, Boca Raton, Florida, 33486, United States|Driven Research LLC, Coral Gables, Florida, 33134, United States|Skin Care Research, Hollywood, Florida, 33021, United States|International Clinical Research - FL LLC, Sanford, Florida, 32771, United States|Metabolic Research Institute, Inc, West Palm Beach, Florida, 33401, United States|DS Research of Southern Indiana, Clarksville, Indiana, 47129, United States|DS Research of Kentucky, Louisville, Kentucky, 40241, United States|Lawrence J. Green, MD LLC, Rockville, Maryland, 20850, United States|JDR Dermatology Research, Las Vegas, Nevada, 89148, United States|The Skin Center Dermatology Group, New City, New York, 10956, United States|Bobby Buka MD, PC, New York, New York, 10012, United States|Hickory Dermatology Research Center, Hickory, North Carolina, 28602, United States|The Skin Surgery Center for Clinical Research, Winston-Salem, North Carolina, 27103, United States|Central Sooner Research, Oklahoma City, Oklahoma, 73170, United States|Dermatology Associates of Plymouth Meeting, Plymouth Meeting, Pennsylvania, 19462, United States|Cumberland Skin Center for Clinical Research, Hermitage, Tennessee, 37076, United States|Dermatology Treatment and Research Center, Dallas, Texas, 75230, United States|Austin Insitute for Clinical Research, Pflugerville, Texas, 78660, United States|Jordan Valley Dermatology Center, South Jordan, Utah, 84095, United States|SimcoDerm Medical and Surgical Dermatology Center, Barrie, Ontario, L4M 7G1, Canada|Lynderm Research Inc., Markham, Ontario, L3P 1X3, Canada|Siena Medical Research, Montréal, Quebec, H3Z 2S6, Canada

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

Primary Outcome Measures: 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 Outcome Measures: To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV., Proportion of subjects who achieve a ≥50% improvement and mean and percent changes from baseline in T-VASI at Week 52., Week 52|To evaluate the efficacy of VYN201 as measured by F-VASI over time in subjects with NSV., Mean and percent changes from Baseline in F-VASI at Week 24 and Week 52., Week 24 and Week 52|To evaluate the efficacy of VYN201 as measured by Vitiligo Noticeability Scale over time in subjects with NSV., Vitiligo Noticeability Scale (VNS) is the subjects' perception of their vitiligo. A rating of 'More noticeable' would indicate the subject perceived the treatment as ineffective and a rating of 'No longer noticeable' would indicate the subjects' perceived the treatment to be highly effective.

The assessment is rated by the following measures:

1. More noticeable
2. As noticeable
3. Slightly less noticeable
4. A lot less noticeable
5. No longer noticeable, Week 52|To evaluate the safety and tolerability of VYN201 as measured by Treatment-Emergent Adverse Events (TEAEs) over time in subjects with NSV., Frequency and severity of TEAEs. TEAEs will be defined as events that emerge after the first application of IMP having been absent pre-treatment, or worsens relative to the pre-treatment state., Baseline through Week 56|To evaluate the safety and tolerability of VYN201 as measured by Physical Examinations over time in subjects with NSV., Changes from baseline in physical examination findings.

General physical examinations will include: height (cm) and weight (kg), head and neck, eyes, ears, nose and throat, lymph nodes, and the cardiovascular, respiratory systems, abdominal, urologic, and musculoskeletal systems.

Targeted physical examinations will be a symptom-directed evaluation and will include body weight and assessment(s) of the body systems or organs, as indicated by subject's symptoms, AEs, or other findings., Screening through Week 56|To evaluate the safety and tolerability of VYN201 as measured by Local Skin Tolerability assessment over time in subjects with NSV., Changes from baseline in Local Skin Tolerability. Assessment of the dryness, scaling, erythema, hyperpigmentation, burning/stinging and pruritus of the affected area. Incidence of severity grades in skin tolerability are assessed with the following severity scoring:

0 = None

1. = Mild
2. = Moderate
3. = Severe, Baseline through Week 56|To evaluate the safety and tolerability of VYN201 as measured by ECGs over time in subjects with NSV., Changes from baseline in ECG assessments. A standard 12-lead ECG will be used to obtain RR interval (ms), PR interval (ms), QRS interval (ms), QT interval (ms), QTcF (ms), and QTcB (ms)., Screening through Week 56|To evaluate the efficacy of VYN201 as measured by vital signs over time in subjects with NSV., Changes from baseline of vital signs. The following will be monitored as safety variables:

* Systolic and diastolic blood pressure (mmHg)
* Pulse rate (beats per minute)
* Respiration rate (breaths per minute)
* Arterial oxygen saturation (SpO2)
* Body temperature (°C), Screening through Week 56|To evaluate the efficacy of VYN201 as measured by Laboratory Tests over time in subjects with NSV., Changes from baseline in Laboratory Safety assessments. Assessed laboratory values include the following: clinical chemistry/biochemistry, hematology, coagulation parameters, urinalysis, urine drug screen, and viral serology., Screening through Week 56|To determine the PK of VYN201 in subjects with NSV (Cmax), Maximum observed plasma concentration of VYN201, Baseline through Week 52|To determine the PK of VYN201 in subjects with NSV (Tmax), Time to reach Maximum observed plasma concentration of VYN201, Baseline through Week 52|To determine the PK of VYN201 in subjects with NSV (Dose Proportionality), Dose response relationship with VYN201, Week 24 and Week 52|To determine the PK of VYN201 in subjects with NSV (Accumulation Ratio), Ratio of VYN201 accumulation under steady state conditions, Week 24 and Week 52|To determine the PK of VYN201 in subjects with NSV (Time to Steady State Ratio), Time to Steady State Ratio, Week 24 and Week 52