Povorcitinib for Vitiligo

Recruiting at126 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

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. ^{1 2 3 4 5}

How 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. ^{1 2 4 5 6}

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility 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.

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

Treatment Details

Interventions

• Povorcitinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Experimental: Povorcitinib Dose A Experimental Treatment 1 Intervention

Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

In a phase 2 trial involving patients with vitiligo, those using 1.5% ruxolitinib cream showed a significant improvement in facial Vitiligo Area Scoring Index scores, with a mean improvement of 79.9% at week 24 compared to only 1.1% in those who did not respond.

Proteomic analysis revealed distinct inflammatory biomarker profiles between patients who achieved at least a 50% improvement and those who did not, suggesting that these biomarkers could help identify which patients are more likely to benefit from ruxolitinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. Howell, MD., Kuo, FI., Rumberger, B., et al.[2023]

In two 52-week phase 3 trials, 52% of patients treated with ruxolitinib 1.5% cream experienced at least a 75% improvement in their vitiligo, demonstrating its efficacy as a treatment.

Ruxolitinib is the first FDA-approved topical medication for repigmentation in vitiligo patients, showing it is both safe and effective, although its cost may limit accessibility for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review on the Use of Topical Ruxolitinib for the Treatment of Vitiligo. Grossmann, MC., Haidari, W., Feldman, SR.[2023]

The combination of apremilast and narrowband UVB therapy significantly reduces immune cell markers (like CD8+ T cells) and enhances melanogenesis markers in vitiligo skin, suggesting a more effective treatment approach than narrowband UVB alone.

This study supports the clinical observation that apremilast can enhance the repigmentation effects of narrowband UVB therapy in patients with generalized vitiligo, particularly in skin types IV-VI, although it was limited by a small sample size and high dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kim, HJ., Del Duca, E., Pavel, AB., et al.[2023]

Combining low-dose tofacitinib with 308-nm excimer laser treatment shows promise as an effective therapy for patients with nonsegmental vitiligo who have not responded to standard treatments.

This combination therapy could offer a new option for patients struggling with vitiligo, potentially improving their skin condition when other therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. Fang, WC., Lin, SY., Huang, SM., et al.[2022]

Topical tofacitinib, a Janus kinase (JAK) inhibitor, was used in combination with phototherapy for 9 months to treat an adolescent patient with long-standing and treatment-resistant vitiligo.

The treatment resulted in near complete repigmentation of the skin, suggesting that JAK inhibitors may be a promising therapy for vitiligo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. Berbert Ferreira, S., Berbert Ferreira, R., Neves Neto, AC., et al.[2021]

Topical ruxolitinib cream has been shown to significantly improve vitiligo symptoms, with 58% of patients achieving a 50% improvement in Vitiligo Area Scoring Index (VASI) after 52 weeks of treatment, making it an effective option for repigmentation.

The treatment has a favorable safety profile, with only mild adverse effects reported, such as erythema and pruritus, and it offers significant clinical improvements compared to traditional therapies, which may have more severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. Hwang, JR., Driscoll, MS.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Review on the Use of Topical Ruxolitinib for the Treatment of Vitiligo. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. [2023]