What is the mechanism of action of this treatment?

Vitiligo treatments aim to restore skin pigmentation by targeting the underlying autoimmune response that destroys melanocytes, the cells responsible for skin color. Janus kinase (JAK) inhibitors, such as ritlecitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the immune response that leads to melanocyte destruction. By inhibiting this pathway, JAK inhibitors can reduce inflammation and autoimmunity, potentially allowing melanocytes to survive and repopulate the skin. This is crucial for vitiligo patients as it offers a targeted approach to halt disease progression and promote repigmentation, addressing both the cosmetic and psychological impacts of the condition.

What side effects are associated with this type of intervention?

Common treatments for vitiligo include topical corticosteroids, calcineurin inhibitors, and phototherapy. Topical corticosteroids can cause skin thinning, stretch marks, and acne. Calcineurin inhibitors may lead to burning sensations and increased risk of skin infections. Phototherapy can result in sunburn, skin aging, and an increased risk of skin cancer. Janus kinase (JAK) inhibitors, like Ritlecitinib, are being studied for vitiligo and have shown a favorable safety profile in earlier studies. Potential side effects of JAK inhibitors can include infections, headaches, and gastrointestinal issues.

What prior FDA approvals exist?

As of now, there are no FDA-approved oral medications specifically for the treatment of nonsegmental vitiligo, including Janus kinase (JAK) inhibitors like Ritlecitinib. Current treatments for vitiligo primarily include topical corticosteroids, calcineurin inhibitors, and phototherapy. The study of Ritlecitinib represents an exploration into new therapeutic avenues for vitiligo, focusing on the potential benefits of JAK inhibitors.

What other types of research exist?

Promising novel alternatives to Ritlecitinib for vitiligo patients include other JAK inhibitors such as Tofacitinib and Baricitinib, which have shown efficacy in clinical trials. Additionally, biologics targeting immune pathways, such as IL-15 inhibitors, and therapies like afamelanotide, a melanocortin 1 receptor agonist, are also being explored for their potential benefits in treating vitiligo.

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Janus Kinase (JAK) Inhibitor

Ritlecitinib for Vitiligo (Tranquillo 2 Trial)

Kaposvár, Hungary

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

A clinical diagnosis of nonsegmental vitiligo for at least 3 months;

F-VASI ≥0.5 and T-VASI ≥3;

Timeline

Screening 3 weeks

Treatment 26 months

Follow Up baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.

Awards & highlights

Pivotal Trial

Summary

This trial is testing ritlecitinib, a medicine for treating vitiligo, in adults with nonsegmental vitiligo. The medicine works by protecting skin color cells from being destroyed by the immune system. The study will compare ritlecitinib to see if it is safe and effective. Ritlecitinib is being tested for its efficacy in treating alopecia areata and vitiligo.

Who is the study for?

Adults with nonsegmental vitiligo, which causes white skin patches, can join this trial if they've had the condition for at least 3 months. They must be over 18 and willing to stop other vitiligo treatments. Participants should have a certain amount of body and facial skin affected but not on palms or soles.

What is being tested?

The study tests ritlecitinib's safety and effectiveness against placebo in two parts: Part I compares two doses (50 mg & 100 mg) daily to placebo; non-responders after 52 weeks switch to ritlecitinib. In Part II, all receive only the 100 mg dose. The trial involves regular visits for various tests.

What are the potential side effects?

Ritlecitinib has shown a favorable safety profile in earlier studies; however, potential side effects are not detailed here. Typically, such medications may cause reactions like headache, nausea, or mild irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with nonsegmental vitiligo for over 3 months.

Select...

Your F-VASI score is 0.5 or greater and your T-VASI score is 3 or higher.

Select...

You have experienced new or enlarged lesions within the past 3 months (as confirmed by images/records).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 26 months17 visits

Follow Up ~ baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.

Screening ~ 3 weeks

Treatment ~ 26 months

Follow Up ~baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.

This trial's timeline: 3 weeks for screening, 26 months for treatment, and baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 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

Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.

US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52

Secondary study objectives

% CFB in F-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.

% CFB in T-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.

Change from baseline in Dermatology Life Quality Index (DLQI)

+24 more

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT05097716

10%

Hypoglycaemia

10%

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Period 2: Ritlecitinib + Tolbutamide

Period 1: Tolbutamide

Period 2: Ritlecitinib

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 4- Ritlecitinib 100mgExperimental Treatment1 Intervention

Non-randomized open-label Ritlecitinib 100mg QD for 52 weeks.

Group II: Arm 2- Ritlecitinib 50mgExperimental Treatment1 Intervention

Randomized to Ritlecitinib 50 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.

Group III: Arm 1- Ritlecitinib 100 milligrams (mg)Experimental Treatment1 Intervention

Randomized to Ritlecitinib 100 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.

Group IV: Arm 3- PlaceboPlacebo Group1 Intervention

Randomized to Placebo QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ritlecitinib

2020

Completed Phase 1

~60

0 / 3Eligibility 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

Vitiligo treatments aim to restore skin pigmentation by targeting the underlying autoimmune response that destroys melanocytes, the cells responsible for skin color. Janus kinase (JAK) inhibitors, such as ritlecitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the immune response that leads to melanocyte destruction. By inhibiting this pathway, JAK inhibitors can reduce inflammation and autoimmunity, potentially allowing melanocytes to survive and repopulate the skin. This is crucial for vitiligo patients as it offers a targeted approach to halt disease progression and promote repigmentation, addressing both the cosmetic and psychological impacts of the condition.