What side effects are associated with this type of intervention?

Common treatments for vitiligo, particularly Janus Kinase (JAK) inhibitors like povorcitinib, often include side effects such as nasopharyngitis, headache, acne, and gastrointestinal issues like nausea. Other potential side effects may include increased risk of infections, elevated liver enzymes, and changes in blood counts. It is important for patients to discuss these potential risks with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, the FDA has not approved any Janus Kinase (JAK) inhibitors specifically for the treatment of vitiligo. However, JAK inhibitors like ruxolitinib have shown promise in clinical trials for vitiligo and other dermatological conditions. Ruxolitinib cream, for instance, has been studied for its efficacy in treating vitiligo, demonstrating potential benefits in repigmentation. These treatments work by targeting the immune pathways involved in the depigmentation process, similar to the mechanism of action being studied for povorcitinib.

What other types of research exist?

Promising, novel alternatives to Povorcitinib for Vitiligo patients include ruxolitinib cream and narrowband UVB phototherapy.

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Janus Kinase (JAK) Inhibitor

Povorcitinib for Vitiligo

Phase 3

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.

Aged ≥ 18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52 and week 104

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called povorcitinib to see if it can help people with nonsegmental vitiligo, a condition where skin loses its color in patches. The medication might work by stopping the immune system from attacking the cells that give skin its color. Researchers want to find out if it is effective and safe for these patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the medication application site, potential liver issues, headaches, nausea, or other symptoms as seen with similar medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to stop all vitiligo treatments during the study.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52 and week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52 and week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 and week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)

Secondary study objectives

Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales

Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)

Number of participants with Treatment-emergent Adverse Events (TEAEs)

+19 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Povorcitinib

2024

Completed Phase 1

~170

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Janus Kinase (JAK) inhibitors, such as Povorcitinib, work by blocking the activity of enzymes involved in the signaling pathways that lead to inflammation and autoimmunity. For Vitiligo patients, this is significant because the condition involves the immune system attacking melanocytes, the cells that produce skin pigment. By inhibiting these pathways, JAK inhibitors can reduce the immune system's attack on melanocytes, helping to restore pigmentation. This targeted approach offers the potential for more effective and sustained repigmentation, addressing the autoimmune aspect of Vitiligo.