Ritlecitinib for Vitiligo
(Tranquillo Trial)
Recruiting in Palo Alto (17 mi)
+142 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a medication called ritlecitinib, which is taken as oral capsules. It aims to help adults and adolescents who have non-segmental vitiligo, a condition that causes skin to lose its color. The medication works by managing the immune system to stop the skin from losing its color.
Do I need to stop my current medications for the trial?
You can continue taking your current medications as long as they are not for vitiligo and your regimen is stable, meaning no new drugs or dosage changes within 7 days or 5 half-lives before the trial starts. You must stop all other treatments for vitiligo during the trial.
What data supports the idea that Ritlecitinib for Vitiligo is an effective drug?
The available research does not provide specific data on the effectiveness of Ritlecitinib for Vitiligo. Instead, it highlights other treatments like ruxolitinib cream, tofacitinib, and baricitinib, which have shown positive results in repigmenting skin affected by vitiligo. These treatments are part of a group of drugs known as JAK inhibitors, which have been effective in treating vitiligo by helping the skin regain its color.
12345What safety data is available for Ritlecitinib?
Ritlecitinib, also known as LITFULO, has been evaluated for safety in clinical trials for alopecia areata. In a phase 2b-3 study, common mild to moderate adverse effects included headache, nasopharyngitis, and upper respiratory tract infection. This data is relevant as Ritlecitinib is also being developed for vitiligo.
16789Is the drug Ritlecitinib a promising treatment for vitiligo?
Ritlecitinib is a promising drug because it is being developed for vitiligo and has already shown success in treating similar conditions like alopecia areata. It works by preventing the immune system from attacking the body's own cells, which is helpful in conditions like vitiligo where the immune system attacks skin cells.
13679Eligibility Criteria
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.Inclusion Criteria
My vitiligo is either not changing or slowly getting worse.
I am 18 years or older, or between 12 and 17 with special approval outside the US.
I have trichrome lesions.
+8 more
Exclusion Criteria
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 have vitiligo or another skin condition.
I have been hospitalized or treated for a serious infection recently.
+1 more
Participant Groups
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.
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)
Ritlecitinib is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Litfulo for:
- Severe alopecia areata
🇺🇸 Approved in United States as Litfulo for:
- Severe alopecia areata
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Site - MarylandLaurel, MD
Washington Hospital Health Care SystemFremont, CA
Clever Medical ResearchMiami, FL
Ziaderm Research LLCNorth Miami Beach, FL
More Trial Locations
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Who Is Running the Clinical Trial?
PfizerLead Sponsor
References
Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. [2023]Efficacy of ruxolitinib cream, a topical Jak1/Jak2 inhibitor, was demonstrated in a phase 2 trial in patients with vitiligo.
Low-dose tofacitinib with 308-nm excimer therapy successfully induced repigmentation in patients with refractory vitiligo. [2022]Combining low-dose tofacitinib with 308-nm excimer may be an effective treatment for patients with nonsegmental vitiligo who were refractory to conventional therapies.
Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient. [2021]Vitiligo is an autoimmune skin disease presenting with areas of depigmentation. Recent reports suggest that Janus kinase (JAK) inhibitors may be an effective therapy. In this case report, we show our experience with an adolescent patient with a long history of generalized and refractory vitiligo, for which treatment with topical tofacitinib, a JAK inhibitor, associated with phototherapy for 9 months, resulted in near complete repigmentation.
Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo. [2023]To review the pharmacokinetics, efficacy, and safety of topical ruxolitinib for treatment of nonsegmental vitiligo.
Baricitinib is Effective in Treating Progressing Vitiligo in vivo and in vitro. [2022]To evaluate the clinical efficacy and safety of baricitinib, a Janus kinase (JAK) inhibitor, in treating patient with progressing vitiligo, and to further explore the regulation of baricitinib on melanocytes (MCs) in vitro.
LITFULOTM (Ritlecitinib) Capsules: A Janus Kinase 3 Inhibitor for the Treatment of Severe Alopecia Areata. [2023]LITFULOTM (ritlecitinib) capsules were recently approved for the treatment of severe alopecia areata in adolescents and adults, aged ≥12 years. Ritlecitinib is the active ingredient and a dual inhibitor of Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma kinase family. It prevents immune attack on the hair follicles that leads to hair loss. In a phase 2b-3 dose-dependant study, five doses of oral ritlecitinib and placebo administered once daily (QD) were investigated. Ritlecitinib demonstrated efficacy in achieving the primary outcome, Severity of Alopecia Tool (SALT) score of ≤20, at week 24 (31% [38/124] 200-mg ritlecitinib QD for 4 weeks, then 50 mg QD for 20 weeks; 22% [27/121] 200-mg ritlecitinib QD for 4 weeks, then 30 mg QD for 20 weeks; 23% [29/124] 50-mg ritlecitinib QD; 14% [17/119] 30-mg ritlecitinib QD; 2% [1/59] 10-mg ritlecitinib QD; and 2% [2/130] placebo). Mild to moderate common adverse effects were observed, which included headache, nasopharyngitis, and upper respiratory tract infection. The recommended regimen of ritlecitinib capsules is 50 mg QD with without food and swallowed whole.
Ritlecitinib: First Approval. [2023]Ritlecitinib (LITFULO™), an orally administered kinase inhibitor, is being developed by Pfizer for the treatment of alopecia areata, vitiligo, ulcerative colitis and Crohn's disease. On 23 June 2023, ritlecitinib received approval in the USA for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Ritlecitinib was approved in Japan on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Ritlecitinib has also received a positive opinion in the EU and is under regulatory review in the UK and China. This article summarizes the milestones in the development of ritlecitinib leading to this first approval for severe alopecia areata.
Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. [2021]Vitiligo is a chronic autoimmune disease resulting in skin depigmentation and reduced quality of life. There is no approved treatment for vitiligo repigmentation and current off-label therapies have limited efficacy, emphasising the need for improved treatment options. We investigated the therapeutic potential of ruxolitinib cream in patients with vitiligo and report the efficacy and safety results up to 52 weeks of double-blind treatment.
Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. [2023]Ritlecitinib is an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor undergoing parallel clinical development for alopecia areata, vitiligo, ulcerative colitis, Crohn's disease, and rheumatoid arthritis.