What side effects are associated with this type of intervention?

Common treatments for vitiligo include topical corticosteroids, calcineurin inhibitors, phototherapy, and JAK inhibitors like Ritlecitinib. The known side effects of JAK inhibitors can include increased risk of infections, headaches, acne, and gastrointestinal issues. Topical corticosteroids may cause skin thinning, stretch marks, and acne. Calcineurin inhibitors can lead to burning sensations and increased risk of skin infections. Phototherapy might result in skin redness, itching, and an increased risk of skin cancer with prolonged use.

What prior FDA approvals exist?

As of now, there are no FDA-approved Janus kinase (JAK) inhibitors specifically for the treatment of vitiligo. However, other treatments for vitiligo include topical corticosteroids, calcineurin inhibitors, and phototherapy. The study of Ritlecitinib, a JAK inhibitor, represents a novel approach in the treatment of vitiligo, aiming to address the underlying immune mechanisms involved in the condition.

What other types of research exist?

Promising novel alternatives to Ritlecitinib for Vitiligo patients include ruxolitinib cream, which has shown efficacy and safety in phase 3 trials for atopic dermatitis and is being explored for vitiligo. Another potential alternative is the use of phototherapy, specifically narrowband ultraviolet B (UVB) therapy, which has been effective in treating vitiligo. These treatments offer different mechanisms of action and have demonstrated positive outcomes in related dermatological conditions.

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Janus Kinase (JAK) Inhibitor

Ritlecitinib for Vitiligo (Tranquillo Trial)

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 non segmental vitiligo for at least 3 months;

BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, dorsal aspect of fingers and thumbs including metacarpophalangeal joints, soles of the feet, or dorsal aspect of the feet;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 4, week 8, week 12, week 24, week 36, week 48

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called ritlecitinib, which is taken as oral capsules. It aims to help adults and adolescents who have non-segmental vitiligo, a condition that causes skin to lose its color. The medication works by managing the immune system to stop the skin from losing its color.

Who is the study for?

Adults and adolescents with vitiligo, both active (with at least one active lesion) and stable (no signs of disease progression), can join this study. Participants must have a certain amount of facial involvement and overall body surface area affected by vitiligo. Those under 18 may join in some regions if approved. People with skin conditions that could affect the trial or severe psychiatric issues, recent infections requiring hospitalization, or other health risks are excluded.

What is being tested?

The trial is testing Ritlecitinib oral capsules for treating vitiligo over a period of 52 weeks against a placebo (a pill without any medication). The goal is to see if Ritlecitinib helps restore skin color in patients with either active spots where pigment is lost or stable conditions where there hasn't been any change.

What are the potential side effects?

While specific side effects for Ritlecitinib in this trial aren't listed, common side effects from similar medications include headaches, nausea, digestive issues, fatigue, and potential allergic reactions. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with non-segmental vitiligo for over 3 months.

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My skin condition affects 4%-60% of my body, not including hands, fingers, feet, or toes.

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I have a skin condition affecting more than half a percent of my face.

Select...

I experience skin color loss in areas where my skin has been injured.

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My vitiligo has not changed or worsened recently.

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I have at least one active vitiligo lesion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 4, week 8, week 12, week 24, week 36, week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 4, week 8, week 12, week 24, week 36, week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 4, week 8, week 12, week 24, week 36, week 48 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), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities

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

Secondary study objectives

All Countries: Proportion of participants achieving disease stabilization

All Countries: Time to rescue medication

Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)

+32 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 2: Ritlecitinib

Period 1: Tolbutamide

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: Ritlecitinib 50 mgExperimental Treatment1 Intervention

Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)

Group II: PlaceboPlacebo Group1 Intervention

Placebo (placebo arm; approximately 200 participants)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ritlecitinib

2020

Completed Phase 1

~60

0 / 6Eligibility 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 Ritlecitinib, 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 JAK enzymes, these treatments can reduce the immune system's attack on melanocytes, potentially leading to repigmentation of the skin. This mechanism helps patients understand how these treatments can manage their condition and what outcomes to expect.