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Janus Kinase (JAK) Inhibitor

Arm 1- Ritlecitinib 100 milligrams (mg) 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

Tranquillo 2 Trial Summary

This trial is studying the safety and effects of a medicine, ritlecitinib, to see if it can help people with nonsegmental vitiligo, which causes white patches on skin. Participants will be randomly assigned one of three treatments and take part in tests and procedures.

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.Check my eligibility
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.See study design
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.

Tranquillo 2 Trial 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.

Tranquillo 2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
Incidence of Clinically significant laboratory abnormalities.
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.
+1 more
Secondary outcome measures
Change from baseline in Dermatology Life Quality Index (DLQI)
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Global (Other Than US): Response based on T-VASI50 at Week 52
+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

Tranquillo 2 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
~50

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,914,576 Total Patients Enrolled
8 Trials studying Vitiligo
182,727 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,090,771 Total Patients Enrolled
3 Trials studying Vitiligo
1,366 Patients Enrolled for Vitiligo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals being recruited for participation in this experiment currently?

"Affirmative. The information displayed on clinicaltrials.gov shows that this study, first posted November 8th 2023, is actively looking for applicants. In total 1450 patients need to be recruited from 28 distinct locations."

Answered by AI

What degree of security has been established with a dosage of 100 milligrams (mg) Ritlecitinib?

"Based on the available evidence, Power has assigned a score of 3 to ritlecitinib 100 milligrams in regards to safety. This is due to Phase 3 trial data that supports both efficacy and repeated rounds of safety testing."

Answered by AI

Are there multiple locations in the US that are presently administering this research?

"Eligible individuals can receive treatment from one of 31 registered medical centres, including Complete Dermatology in Sugar Land, Texas; NanYang First people's hospital in Nanyang, Henan; Total Skin & Beauty Dermatology Center, PC In Birmingham, Alabama."

Answered by AI

What is the current enrollment total for this experiment?

"This investigation necessitates the enrolment of 1450 suitable participants from Complete Dermatology in Sugar Land, TX and NanYang First people's hospital in Nanyang, Henan."

Answered by AI

Who else is applying?

What site did they apply to?
OptiSkin Medical
Center for Dermatology and Plastic Surgery/CCT Research
NorthShore University Health System
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Previous Vitiligo treatments not successful.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
2023. "A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072183.
All > Kansas City > Vancouver
~967 spots leftby Jul 2027
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