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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 36 and 52 weeks
Awards & highlights

Tranquillo Trial Summary

This trial studied the effects of ritlecitinib capsules on adults & teens with vitiligo, to observe changes in skin pigmentation & overall condition.

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.Check my eligibility
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.See study design
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.

Tranquillo Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with non-segmental vitiligo for over 3 months.
Select...
My skin condition affects 4%-60% of my body, not including hands, fingers, feet, or toes.
Select...
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.
Select...
My vitiligo has not changed or worsened recently.
Select...
I have at least one active vitiligo lesion.

Tranquillo Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
F-VASI75 and T-VASI50 comprise the primary endpoint family at 52 weeks
For the EU: Proportion of participants achieving F-VASI75 at Week 52.
Secondary outcome measures
CDLQI/DLQI
For the EU: Proportion of participants achieving T-VASI50 at Week 52
Anxiety
+8 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 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
~50

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,274 Total Patients Enrolled
8 Trials studying Vitiligo
183,577 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,442 Total Patients Enrolled
3 Trials studying Vitiligo
2,216 Patients Enrolled for Vitiligo

Media Library

Ritlecitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05583526 — Phase 3
Vitiligo Research Study Groups: Ritlecitinib 50 mg, Placebo
Vitiligo Clinical Trial 2023: Ritlecitinib Highlights & Side Effects. Trial Name: NCT05583526 — Phase 3
Ritlecitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583526 — Phase 3
Vitiligo Patient Testimony for trial: Trial Name: NCT05583526 — Phase 3

Frequently Asked Questions

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

Is Ritlecitinib 50 mg safe for patients to use when prescribed?

"There is ample evidence for the safety of Ritlecitinib 50 mg, giving it a score of 3 on our internal scale. This rating reflects both its Phase 3 status and multiple rounds data validating its efficacy."

Answered by AI

What end-result are researchers expecting from this investigation?

"This medical trial will last for just over a year and the primary endpoints are F-VASI75 and T-VASI50 at week 52. Secondary outcomes include Patient Global Impression of Change-Face, PGIS Severity Face, and Proportion of participants achieving F-VASI75 by 24 weeks to evaluate ritlecitinib's comparative efficacy compared to placebo in treating facial vitiligo."

Answered by AI

What is the number of medical centers currently administering this experiment?

"At this moment, 8 medical sites are enrolling suitable patients for the trial. These locations include Lutz, Miami and Baton Rouge as well as other cities in close proximity to these 3 hubs. It is wise to select a site that requires minimal travel if you decide to become a participant of the study."

Answered by AI

What is the maximum enrollment capacity for this clinical experiment?

"To complete this study, 600 eligible patients are required by the sponsor - Pfizer. These participants will be sourced from two clinical sites: JC Audiology in Lutz, Louisiana and Millennium Clinical Research in Miami, Ohio."

Answered by AI

Are there any open recruitment slots for this research project?

"Affirmative. According to records on clinicaltrials.gov, this medical investigation is currently enrolling individuals after being first posted on December 2nd 2022. 600 candidates need to be sourced from 8 distinct sites by November 30th 2022."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Texas
Florida
Other
What site did they apply to?
Marietta Dermatology Clinical Research, Inc
DelRicht Research
Advanced Medical Research, PC.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
1
3+

What questions have other patients asked about this trial?

What is the compensation and how long does the screening take? I have never been a part of a trial so I am not sure what would be expected. How long is the trial? What is the time commitment per visit and how often are the visits? Would I need to journal anything between visits?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have not tried any treatment. To find a treatment that will stop it from spreading more.
PatientReceived 1 prior treatment
Try to help find a better treatment for a challenging disease. I was look for a medication that would help and to make extra money.
PatientReceived no prior treatments
I’ve tried 2 other topical drugs excluding opzelura with no success.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Marietta Dermatology Clinical Research, Inc: < 24 hours
  2. Millennium Clinical Research: < 24 hours
  3. PMG Research of Wilmington, LLC: < 24 hours
Average response time
  • < 2 Days
~280 spots leftby Jun 2025