Povorcitinib for Vitiligo

Not currently recruiting at 145 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 tests a new treatment called povorcitinib to determine its effectiveness and safety for people with nonsegmental vitiligo, a condition causing patches of skin to lose color. Participants will receive either povorcitinib or a placebo (a look-alike with no active ingredient) for a year, after which everyone will receive povorcitinib. This trial may be suitable for individuals diagnosed with nonsegmental vitiligo affecting noticeable skin areas and who are willing to pause other treatments during the study. 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 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.

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

Research has shown that povorcitinib is generally safe and well tolerated. In earlier studies, no new safety issues emerged, and participants handled the treatment well. One study even showed that patients using povorcitinib experienced significant skin repigmentation without major safety problems. While detailed safety information continues to be collected, the results so far are encouraging for those considering participation in trials with povorcitinib. ^{1 2 3 4 5}

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

Unlike the standard treatments for vitiligo, which often include corticosteroids and topical immunomodulators, Povorcitinib is unique because it targets the Janus kinase (JAK) pathway. This pathway is involved in the immune response that contributes to the skin depigmentation seen in vitiligo. By specifically inhibiting JAK, Povorcitinib may offer a more targeted approach to restoring skin pigment. Researchers are excited about Povorcitinib because it could potentially provide a more effective and sustained repigmentation compared to current treatments, with the added benefit of fewer side effects.

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

Research shows that povorcitinib may help treat nonsegmental vitiligo, a condition that causes skin to lose its color. In this trial, participants will join different arms, with some receiving Povorcitinib Dose A and others a placebo. Studies have found that patients using povorcitinib showed noticeable improvements in restoring skin color. Specifically, one study revealed that after 52 weeks, patients experienced significant repigmentation on their face and body. Another study found that after 24 weeks, those taking povorcitinib had more repigmentation than those on a placebo. This treatment works by blocking a protein called Janus kinase 1, which plays a role in the immune system and inflammation, possibly aiding in restoring skin color. ^{1 3 4 6 7}

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, 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.

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

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

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 individuals with nonsegmental vitiligo. It aims to see if this medication can improve skin condition compared to no active treatment.

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]

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]

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]

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]

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06113445

NCT06113445 | A Study to Evaluate Efficacy and Safety of ... A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo.

7. healio.com healio.com/news/dermatology/20250317/new-data-support-efficacy-safety-of-povorcitinib-for-hidradenitis-suppurativa

New data support efficacy, safety of povorcitinib for ... Povorcitinib was considered well tolerated with no new safety signals. Newly released data from the phase 3 STOP-HS clinical trial program ...