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Ritlecitinib for Vitiligo (Tranquillo Trial)
Tranquillo Trial Summary
This trial studied the effects of ritlecitinib capsules on adults & teens with vitiligo, to observe changes in skin pigmentation & overall condition.
Tranquillo Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTranquillo Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 trial • 12 Patients • NCT05097716Tranquillo Trial Design
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Who is running the clinical trial?
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- My vitiligo is either not changing or slowly getting worse.You have a medical or psychiatric condition that could make participating in the study potentially harmful for you or make you unsuitable for the study.I am 18 years or older, or between 12 and 17 with special approval outside the US.I have vitiligo or another skin condition.I have trichrome lesions.I have been hospitalized or treated for a serious infection recently.I have at least one active vitiligo lesion.I have a skin condition affecting more than half a percent of my face.I experience skin color loss in areas where my skin has been injured.You have a certain level of skin lesions on your face and scalp.I have been diagnosed with non-segmental vitiligo for over 3 months.My vitiligo has not changed or worsened recently.You have a mental health condition, including recent or current thoughts of harming yourself.My skin condition affects 4%-60% of my body, not including hands, fingers, feet, or toes.You have a skin lesion that looks like colorful confetti.
- Group 1: Ritlecitinib 50 mg
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Marietta Dermatology Clinical Research, Inc: < 24 hours
- Millennium Clinical Research: < 24 hours
- PMG Research of Wilmington, LLC: < 24 hours
Average response time
- < 2 Days
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