Povorcitinib for Vitiligo

Not currently recruiting at 111 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Depigmenting agents

Disqualifiers: Pregnancy, Cardiovascular diseases, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new treatment, povorcitinib, for individuals with nonsegmental vitiligo, a condition that causes patches of skin to lose color. Participants will receive either the actual treatment or a placebo (a substance with no active drug) to compare effects over time. Suitable candidates have nonsegmental vitiligo covering at least 5% of their body and are willing to stop other treatments for this condition during the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop using any treatments specifically for vitiligo from the screening through the final safety follow-up visit. It does not specify about other medications, so you may need to discuss this with the trial team.

Is there any evidence suggesting that povorcitinib is likely to be safe for humans?

Studies have shown that povorcitinib is generally well-tolerated in people with nonsegmental vitiligo. Research indicates that it helps restore skin color, a main goal of vitiligo treatment. Reports from previous studies highlight that povorcitinib led to noticeable improvements in skin color without major safety concerns. While some side effects can occur with any medication, the studies did not find any unexpected or severe side effects with povorcitinib. This suggests that the treatment is safe for most people, with no serious issues reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for vitiligo?

Researchers are excited about Povorcitinib for vitiligo because it targets a different mechanism compared to existing treatments. Most treatments for vitiligo, such as topical corticosteroids and calcineurin inhibitors, focus on reducing inflammation. However, Povorcitinib is a Janus kinase (JAK) inhibitor, which works by blocking specific pathways involved in the immune response that leads to skin depigmentation. This unique approach could offer a new and potentially more effective solution for restoring skin color in people with vitiligo.

What evidence suggests that povorcitinib might be an effective treatment for vitiligo?

Research has shown that povorcitinib is likely effective for treating nonsegmental vitiligo. In earlier studies, patients using povorcitinib experienced significant improvements in restoring their skin color. In this trial, participants in the experimental arm will receive Povorcitinib Dose A for 52 weeks. After 52 weeks, more patients achieved a 50% reduction in vitiligo severity compared to results at 24 weeks. The treatment led to noticeable repigmentation on the face and body. These findings suggest that povorcitinib can help restore skin color in people with vitiligo. ^{2 4 6 7 8}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with nonsegmental vitiligo, which causes loss of skin color in blotches. Participants should have a certain level of skin involvement and agree to stop other vitiligo treatments during the study. They must also take precautions to prevent pregnancy or avoid fathering children.

Inclusion Criteria

I agree to stop all vitiligo treatments during the study.

Your F-VASI score is at least 0.5 or higher.

More than 5% of your body surface area is affected by the condition being studied.

Timeline for a Trial Participant

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

Extension

Participants who received placebo switch to Povorcitinib Dose A for an additional 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

Trial Overview The trial is testing Povorcitinib's effectiveness and safety against a placebo in treating nonsegmental vitiligo. Participants will randomly receive either the actual drug or a placebo to compare results between the two groups.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-52-week-data-phase-2b-study-evaluating

Incyte Announces Positive 52-Week Data from Phase 2b ... More on-treatment patients achieved ≥50% reduction from baseline in T-VASI (T-VASI50) at Week 52 compared to initial findings at Week 24 ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40518122/

Efficacy and safety of the oral Janus kinase 1 inhibitor ... At week 24, povorcitinib significantly improved T-VASI from baseline (15 mg, 19.1%; 45 mg, 17.8%; 75 mg, 15.7%) versus placebo (-2.3%; least squares mean ...

3. academic.oup.com academic.oup.com/bjd/article-abstract/191/Supplement_2/ljae266.094/7728676

Efficacy and safety of povorcitinib for extensive vitiligo: 52 ... Oral povorcitinib was associated with substantial facial and total body repigmentation in patients with extensive nonsegmental vitiligo through 52 weeks of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04818346?tab=results

NCT04818346 | A Study to Evaluate the Efficacy and ... These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the ...

5. jaad.org jaad.org/article/S0190-9622(25)02304-7/fulltext

Efficacy and safety of the oral Janus kinase 1 inhibitor ... Povorcitinib demonstrated substantial total body and facial repigmentation in adult patients with extensive nonsegmental vitiligo and was ...

6. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-data-phase-2b-study-evaluating-povorcitinib

Incyte Announces Data from Phase 2b Study Evaluating ... Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06113445

NCT06113445 | A Study to Evaluate Efficacy and Safety of ... This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225023047

Efficacy and safety of the oral Janus kinase 1 inhibitor ... Povorcitinib demonstrated substantial total body and facial repigmentation in adult patients with extensive nonsegmental vitiligo and was generally well ...