Vitiligo

 

Below is a list of our vitiligo studies that are currently enrolling.

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non-Segmental Vitiligo

 

• Population: Adult participants 18-75 years of age with non-segmental vitiligo
• Study Condition: Non-segmental vitiligo, both active and stable, in participants with a diagnosis for at least 6 months with inclusive body surface area involvement of ≥4% and body surface area and involvement on the face
• Study Design: This study is a phase 2a randomized, double-blind, placebo-controlled study investigating the efficacy and safety of MK-6194 in adult participants with non-segmental vitiligo. Participants will be randomized to receive subcutaneous injections of the investigational drug MK-6194 or its corresponding placebo.
• Duration: 52 weeks
• Compensation is provided for participation
• Study is currently enrolling

 

Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo

• Population: Participants aged 12 years or older
• Study Condition: Non-Segmental Vitiligo (NSV)
• Study Design: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with NSV who are eligible for systemic therapy. This study is comprised of a 35-day Screening Period; a 48-week placebo-controlled, double-blinded treatment period (Period A); a 112-week open-label extension period (Period B); and a 30-day follow-up period. In Period A, adult and adolescent subjects who meet eligibility criteria will be randomized 2:1 to receive daily oral doses of upadacitinib 15 mg or matching placebo. Subjects who complete Period A will continue into Period B and will receive open-label upadacitinib 15 mg.
• Duration: Approximately 168 weeks
• Compensation may be provided for participation

Phase III Vitiligo Study

• Population: Participants aged 12 years or older
• Study Condition: Stable or active vitiligo diagnosed for at least three months
• Study Design: This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalized vitiligo. Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
  • Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105(±4) and 126 (±4) (seven implants in total));

  To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

• Duration: Approximately 12 months
• Compensation may be provided for participation.

• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).

 

A Phase 3 Randomized, Double-Blind, 52-Week Placebo-Controlled, Multi-Center Study Investigating The Efficacy, Safety, and Tolerability of Ritlecitinib In Adult And Adolescent Participants With Non Segmental Vitiligo 

 

• Population: Adult participants ≥18 years of age with non-segmental vitiligo
• Study Condition: Non-segmental vitiligo, both active and stable, in participants with a diagnosis for at least 3 months with inclusive body surface area involvement of 4%-60% and body surface area ≥0.5% involvement on the face
• Study Design: This study is a phase 3 randomized, double-blind, placebo-controlled, multi-center study investigating the efficacy, safety, and tolerability of Ritlecitinib in adult participants with non-segmental vitiligo. Participants will be randomized to receive a daily set dose of the oral investigational drug Ritlecitinib, 50 mg or its corresponding placebo.
  • Arm 1: Ritlecitinib 50mg
  • Arm 2: Placebo
• Duration: 52 weeks
• Compensation is provided for participation
• Study is currently enrolling

 

Please contact Dr. Veronica Emmerich for more information regarding ongoing vitiligo studies.

Email: emmerich@musc.edu

Phone: (843) 876-0110