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Janus Kinase (JAK) Inhibitor

Ritlecitinib for Vitiligo (Tranquillo 2 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
Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening.
A clinical diagnosis of nonsegmental vitiligo for at least 3 months;
Timeline
Screening 3 weeks
Treatment Varies
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

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
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I am at least 18 years old or meet the minimum age of consent according to local laws.
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I have been diagnosed with nonsegmental vitiligo for over 3 months.
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I have a skin condition affecting more than half a percent of my face.
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I have small, clustered white spots on my skin.
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My skin has areas with three different shades.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
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, Varies 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
8%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 1: Tolbutamide
Period 2: Ritlecitinib
Period 2: Ritlecitinib + Tolbutamide

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

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.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,282,744 Total Patients Enrolled
8 Trials studying Vitiligo
182,727 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,457,320 Total Patients Enrolled
3 Trials studying Vitiligo
1,366 Patients Enrolled for Vitiligo
~967 spots leftby Jul 2027
Unbiased ResultsWe believe in providing patients with all the options.
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