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 can include increased risk of infections, elevated liver enzymes, and changes in blood counts. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of treatment.

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 autoimmune conditions. Ruxolitinib cream, for instance, has been studied for its efficacy in repigmenting vitiligo patches. The ongoing research, including the study of povorcitinib, aims to establish the safety and efficacy of JAK inhibitors in treating vitiligo.

What other types of research exist?

Promising alternatives to Povorcitinib for Vitiligo patients could include other Janus Kinase inhibitors like Ruxolitinib, which has shown efficacy in treating atopic dermatitis. Additionally, narrowband ultraviolet B (UVB) phototherapy is a well-established treatment for various skin conditions and might be considered. Consulting with a healthcare provider for personalized treatment options is recommended.

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Tyrosine Kinase 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

Aged ≥ 18 years.

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

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 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical drug-related side effects may include nausea, headaches, possible allergic reactions, or skin irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I agree to stop all vitiligo treatments during the study.

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. In vitiligo, the immune system attacks melanocytes, the cells that produce skin pigment. By inhibiting JAK enzymes, these treatments can reduce the immune system's attack on melanocytes, potentially allowing for repigmentation of the skin. This targeted approach is crucial for vitiligo patients as it addresses the underlying autoimmune component of the disease, offering a promising strategy to manage and potentially reverse depigmentation.