Ritlecitinib for Baldness
(B7981027 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, ritlecitinib, for treating severe alopecia areata, a condition causing significant hair loss. The researchers aim to determine if ritlecitinib is safe and effective in promoting hair regrowth. Participants will receive either ritlecitinib at varying doses or a placebo (a pill with no active medicine) for comparison. Suitable candidates have lost at least half of their scalp hair due to alopecia areata and are either vaccinated against chickenpox or have had the infection. The study lasts six months, with regular clinic visits and phone calls to monitor progress. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for alopecia areata.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that ritlecitinib is likely to be safe for humans?
Research has shown that ritlecitinib is generally well-tolerated by people with alopecia areata. In studies involving patients with significant hair loss, ritlecitinib produced positive results and remained safe for long-term use. A detailed safety review confirmed that the treatment's side effects aligned with earlier findings, revealing no new or unexpected side effects.
In a controlled study, participants taking ritlecitinib experienced no major safety issues compared to those taking a placebo (a non-active treatment). This suggests that the treatment is safe for people with alopecia areata.12345Why do researchers think this study treatment might be promising for alopecia areata?
Most treatments for baldness, like minoxidil or finasteride, work by stimulating hair growth or blocking hormones that lead to hair loss. But Ritlecitinib works differently, targeting the JAK-STAT signaling pathway, which is involved in inflammation that can lead to hair loss. Researchers are excited about Ritlecitinib because it offers a novel approach, potentially leading to more effective results for people who haven’t responded well to existing treatments. Additionally, the treatment is available in a capsule form, making it easy to incorporate into daily routines.
What evidence suggests that ritlecitinib might be an effective treatment for alopecia areata?
Research has shown that ritlecitinib may help treat severe alopecia areata, a condition that causes hair loss. In earlier studies, 14% to 31% of patients experienced significant hair regrowth, with only 20% or less of their scalp still affected by hair loss. Another study found that almost one-third of patients achieved complete hair regrowth after three years of treatment. Ritlecitinib was generally well tolerated, with most people not experiencing serious side effects. This trial will evaluate different doses of ritlecitinib, with some participants receiving a higher dose and others a lower dose, to determine its effectiveness and safety. These findings suggest that ritlecitinib could be an effective option for those dealing with this condition.14678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for children aged 6 to 12 with severe alopecia areata, which causes significant hair loss. Participants must have lost at least 50% of scalp hair and either had varicella (chickenpox) or been vaccinated against it. In the EU/UK, they should have tried other treatments without success.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ritlecitinib or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension (optional)
Participants may opt into continuation of treatment long-term if eligibility criteria are met
What Are the Treatments Tested in This Trial?
Interventions
- Ritlecitinib
Trial Overview
The study tests ritlecitinib's safety and effectiveness in treating severe alopecia areata. It compares two doses of ritlecitinib against a placebo over six months, with participants taking capsules daily at home and attending eight clinic visits while receiving phone calls from the study team.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.
Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks.
Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Long-term safety and efficacy of ritlecitinib in adults ...
In patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment.
Efficacy and safety of ritlecitinib in adults and adolescents ...
In a placebo-controlled, phase 2a clinical trial, ritlecitinib was efficacious and generally well tolerated in adults with alopecia areata.
Results with LITFULO® (ritlecitinib) | Safety Info
View study results and before-and-after photos of actual patients with severe alopecia areata and explore the safety and effectiveness of LITFULO® medication.
New Clinical Trial Data Published for Ritlecitinib
Between 14% and 31% of patients in the different treatment groups reached the study endpoint, which was 20% or less scalp hair loss. In addition ...
Complete hair regrowth for some with alopecia after 3-year ...
Almost one-third of people treated for 3 years with ritlecitinib for alopecia areata achieved complete scalp hair regrowth, according to a study ...
Pooled Safety Data
In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 patients were exposed to LITFULO with 130 patients receiving LITFULO 50 ...
Study Details | NCT04517864 | PLACEBO-CONTROLLED ...
This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ...
Updated Integrated Safety Analysis of Ritlecitinib Up to
Conclusion Ritlecitinib was generally well tolerated ~5 years in patients with AA. Safety was consistent with previously reported data. Funding ...
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