Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Incyte Corporation
Must not be taking: Depigmenting agents
Disqualifiers: Pregnancy, Cardiovascular diseases, Infections, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a medication called povorcitinib to see if it can help people with nonsegmental vitiligo, a condition that causes white patches on the skin. The medication might work by calming the immune system to prevent it from attacking the skin. Researchers want to find out if this treatment is both effective and safe.
Will I have to stop taking my current medications?
The trial requires participants to stop using all treatments for vitiligo from the screening through the final safety follow-up visit. However, it does not specify if you need to stop other medications not related to vitiligo.
What data supports the effectiveness of the drug Povorcitinib for treating vitiligo?
Research on similar drugs, like tofacitinib and ruxolitinib, which are also Janus kinase (JAK) inhibitors, shows they can help repigment skin in vitiligo patients. These studies suggest that JAK inhibitors may be effective for vitiligo treatment.
12345How is the drug Povorcitinib different from other vitiligo treatments?
Povorcitinib is a Janus kinase (JAK) inhibitor, similar to other treatments like tofacitinib and ruxolitinib, which have shown effectiveness in treating vitiligo by targeting the immune system to help repigment the skin. What makes Povorcitinib unique is its specific formulation and potential effectiveness, as it is being studied in clinical trials specifically for vitiligo, whereas other JAK inhibitors have been used off-label or in combination with other therapies.
12456Eligibility Criteria
This trial is for adults over 18 with nonsegmental vitiligo, having a certain amount of body surface area affected. Participants must not be treating their vitiligo with other methods during the study and agree to prevent pregnancy or fathering children.Inclusion Criteria
Your F-BSA is at least 0.5%.
Your total body surface area (T-BSA) is more than 5%.
Your T-VASI score is 4 or higher.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Povorcitinib Dose A or Placebo for 52 weeks
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Extension
Participants receive Povorcitinib Dose A for an additional 52 weeks
52 weeks
Participant Groups
The trial is testing Povorcitinib's effectiveness and safety against a placebo in individuals with nonsegmental vitiligo. It aims to see if this medication can improve skin condition compared to no active treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Povorcitinib Dose AExperimental Treatment1 Intervention
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Sinai Medical CenterNew York, NY
Encore Medical Research, LlcHollywood, FL
University of Texas Physicians - Bellaire StationBellaire, TX
Randall DermatologyKokomo, IN
More Trial Locations
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Who Is Running the Clinical Trial?
Incyte CorporationLead Sponsor
References
Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. [2023]Efficacy of ruxolitinib cream, a topical Jak1/Jak2 inhibitor, was demonstrated in a phase 2 trial in patients with vitiligo.
A Review on the Use of Topical Ruxolitinib for the Treatment of Vitiligo. [2023]This article describes the clinical trial, safety, and efficacy of ruxolitinib 1.5% cream or repigmentation in patients with vitiligo.
Apremilast and narrowband ultraviolet B combination therapy suppresses Th17 axis and promotes melanogenesis in vitiligo skin: a randomized, split-body, pilot study in skin types IV-VI. [2023]Improved repigmentation of generalized vitiligo in skin types IV-VI has been reported in clinical response to combined therapy with apremilast and narrowband (NB)-UVB; however, tissue responses to combined therapy versus NB-UVB monotherapy have not been elucidated. We compared the change from baseline in cellular and molecular markers in vitiligo skin after combined therapy versus NB-UVB monotherapy. We assessed lesional and nonlesional skin samples from enrolled subjects and evaluated for immune infiltrates, inflammatory, and melanogenesis-related markers which were compared across different treatment groups. Combined therapy resulted in significant reduction of CD8+T cells and CD11c+ dendritic cells, downregulation of PDE4B and Th17-related markers, and upregulation of melanogenesis markers. This study was limited to small sample size, skin types IV-VI, and high dropout rate. Our molecular findings support the clinical analysis that apremilast may potentiate NB-UVB in repigmentation of generalized vitiligo in skin types IV-VI.
Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. [2022]Combining low-dose tofacitinib with 308-nm excimer may be an effective treatment for patients with nonsegmental vitiligo who were refractory to conventional therapies.
Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. [2021]Vitiligo is an autoimmune skin disease presenting with areas of depigmentation. Recent reports suggest that Janus kinase (JAK) inhibitors may be an effective therapy. In this case report, we show our experience with an adolescent patient with a long history of generalized and refractory vitiligo, for which treatment with topical tofacitinib, a JAK inhibitor, associated with phototherapy for 9 months, resulted in near complete repigmentation.
Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. [2023]To review the pharmacokinetics, efficacy, and safety of topical ruxolitinib for treatment of nonsegmental vitiligo.