What side effects are associated with this type of intervention?

Ruxolitinib cream, a Janus kinase (JAK) inhibitor, is being studied for its efficacy and safety in treating vitiligo. Common side effects of JAK inhibitors like Ruxolitinib include application site reactions such as redness, itching, and irritation. Systemic side effects are less common but can include increased risk of infections, acne, and elevated liver enzymes. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of the treatment.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for vitiligo that are similar to Ruxolitinib cream, a Janus kinase (JAK) inhibitor. However, Ruxolitinib cream is currently being studied for its efficacy and safety in treating non-segmental vitiligo. This study aims to evaluate its use with or without phototherapy in patients with vitiligo affecting up to 10% of their body surface area. Other JAK inhibitors, such as tofacitinib, have shown promise in treating autoimmune conditions like alopecia areata, but their use in vitiligo remains under investigation.

What other types of research exist?

Promising alternatives to Ruxolitinib cream for vitiligo patients include: 1) Tacrolimus, a topical calcineurin inhibitor, which has shown efficacy in combination therapies. 2) Phototherapy, particularly narrowband UVB, which is often used in conjunction with topical treatments. 3) Emerging biologics and small molecules targeting specific pathways involved in vitiligo pathogenesis, such as IL-15 inhibitors and other JAK inhibitors under investigation. Patients should discuss these options with their dermatologist to determine the best individualized treatment plan.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream + Phototherapy for Vitiligo

Q: What is the mechanism of action of this treatment?

Vitiligo treatments aim to restore skin pigmentation by targeting the underlying autoimmune response and promoting melanocyte function. Ruxolitinib cream, a Janus kinase (JAK) inhibitor, works by blocking the JAK-STAT pathway, which is involved in the inflammatory process that leads to melanocyte destruction. By inhibiting this pathway, Ruxolitinib reduces inflammation and helps in the repigmentation of the skin. This is crucial for Vitiligo patients as it addresses the root cause of the depigmentation, potentially leading to more effective and sustained results compared to treatments that only manage symptoms. Other common treatments include corticosteroids and phototherapy, which also aim to reduce inflammation and stimulate melanocyte activity, but may not target the specific pathways involved in the autoimmune response as precisely as JAK inhibitors.

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special cream called Ruxolitinib, sometimes combined with light therapy, on teenagers and adults with a type of vitiligo that affects less than 10% of their skin. The cream works by calming the immune system in the skin, and the light therapy helps improve skin color. The cream has shown repigmentation effects in previous studies for vitiligo.

Who is the study for?

This trial is for adolescents and adults with non-segmental vitiligo, where the affected area doesn't cover more than 10% of their body. Participants should have a certain level of facial and body depigmentation. They must stop other vitiligo treatments during the study and can't join if they have skin infections, other skin diseases, serious health issues, no pigmented hair in vitiligo areas on the face, used certain past treatments or had bad reactions to phototherapy.

What is being tested?

The trial tests Ruxolitinib cream's effectiveness and safety when used alone or combined with NB-UVB phototherapy for treating non-segmental vitiligo. It focuses on participants whose condition affects less than 10% of their body surface area.

What are the potential side effects?

Potential side effects may include local skin reactions at the application site such as redness, itching or irritation. Systemic side effects are not detailed but could be similar to those seen with other topical medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 14 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in T-VASI

Secondary study objectives

Number of treatment-related adverse events

Percentage change from baseline in F-BSA at each post-baseline visit

Percentage change from baseline in F-VASI at each post-baseline visit

+5 more

Side effects data

From 2016 Phase 4 trial • 97 Patients • NCT01553058

upper respiratory infection

vasovagal syncope

joint range of motion decrease

nasal congestion

headache

100%

80%

60%

40%

20%

Study treatment Arm

Adalimumab (Humira)

Placebo Injection

NB-UVB Phototherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Ruxolitinib MonotherapyExperimental Treatment1 Intervention

Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.

Group II: Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)Experimental Treatment2 Interventions

Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NB-UVB phototherapy

2017

Completed Phase 4

~150

Do I qualify?Apply below to find out

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

Vitiligo treatments aim to restore skin pigmentation by targeting the underlying autoimmune response and promoting melanocyte function. Ruxolitinib cream, a Janus kinase (JAK) inhibitor, works by blocking the JAK-STAT pathway, which is involved in the inflammatory process that leads to melanocyte destruction. By inhibiting this pathway, Ruxolitinib reduces inflammation and helps in the repigmentation of the skin. This is crucial for Vitiligo patients as it addresses the root cause of the depigmentation, potentially leading to more effective and sustained results compared to treatments that only manage symptoms. Other common treatments include corticosteroids and phototherapy, which also aim to reduce inflammation and stimulate melanocyte activity, but may not target the specific pathways involved in the autoimmune response as precisely as JAK inhibitors.