← Back to Search

Other

Arm 2 for Vitiligo (Tranquillo LTE 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to at least 28 days after last dose of study drug (week 52 or early termination)
Awards & highlights

Tranquillo LTE Trial Summary

This trial is studying a medication called ritlecitinib to see how safe and effective it is in treating non-segmental vitiligo, a skin disorder characterized by white patches on the skin

Who is the study for?
This trial is for adults and adolescents who have non-segmental vitiligo and participated in the previous study B7981040 for 52 weeks. They must start this study within 30 days after their last visit in the prior study.Check my eligibility
What is being tested?
The safety and effectiveness of Ritlecitinib, an oral medication, are being tested to see if it can maintain or improve skin repigmentation in patients with non-segmental vitiligo over a period of 52 weeks compared to a placebo.See study design
What are the potential side effects?
While specific side effects for ritlecitinib in this trial aren't listed, common side effects may include reactions at the site of administration, headaches, nausea, and potential immune system impacts.

Tranquillo LTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to at least 28 days after last dose of study drug (week 52 or early termination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to at least 28 days after last dose of study drug (week 52 or early termination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of clinically significant laboratory abnormalities
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Secondary outcome measures
Patient Global Impression of Change- Overall vitiligo (PGIC-V)
Patient Global Impression of Change-Face (PGIC-F)
Patient Global Impression of Severity-Face (PGIS-F)
+10 more

Tranquillo LTE Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
Group II: Arm 1Experimental Treatment3 Interventions
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Ritlecitinib
2020
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,626 Total Patients Enrolled
8 Trials studying Vitiligo
183,777 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,821 Total Patients Enrolled
3 Trials studying Vitiligo
2,416 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.

Has the second arm of this study been granted approval by the FDA?

"Based on the Phase 3 nature of this trial, indicating both efficacy and repeated safety data, Arm 2 has been assigned a safety rating of 3 by our team at Power."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is actively seeking eligible candidates. The study was originally posted on January 22nd, 2024 and underwent its most recent revision on January 29th, 2024. To complete the trial successfully, a total of 400 participants will be enrolled across four designated sites."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"Presently, this clinical trial is accepting patient enrolment from 4 distinct sites. These sites are situated in Huntington Beach and Columbus, as well as Tokyo with an additional four undisclosed locations. To minimize travel obligations, it is advisable to choose the site closest to your current location when considering participation."

Answered by AI

Who else is applying?

What site did they apply to?
DelRicht Research
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have not found a treatment that works.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
2024. "A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163326.
All > Vitiligo > Indianapolis
~267 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top