Ritlecitinib for Alopecia Areata
(PRESTO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of ritlecitinib for individuals with alopecia areata (AA) in a real-world setting. AA is an autoimmune condition that causes hair loss on the scalp, face, and body. The trial will focus on patients already prescribed ritlecitinib, approved for severe cases of AA. Individuals diagnosed with alopecia areata by a dermatologist and willing to attend regular clinic visits may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how the FDA-approved treatment benefits a broader patient population.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor, who will guide you based on your specific situation.
What is the safety track record for ritlecitinib?
Studies have shown that ritlecitinib is generally well tolerated by people with alopecia areata (AA). For those with at least 25% hair loss on their scalp, ritlecitinib has proven effective and safe for long-term use. Common side effects include headaches, sore throat, mild infections, and hives, which are usually not severe and align with previous research findings.
The FDA has approved ritlecitinib for treating severe AA in adults and teens aged 12 and older. This approval is based on positive safety results from earlier studies. Safety data collected over about five years has remained consistent, indicating that the treatment continues to be well tolerated over time.12345Why are researchers enthusiastic about this study treatment?
Ritlecitinib is unique because it targets Janus kinase 3 (JAK3), a specific enzyme involved in the immune response. Most treatments for alopecia areata, like corticosteroids or other immunosuppressants, broadly suppress the immune system, which can lead to a range of side effects. Ritlecitinib, on the other hand, offers a more targeted approach, potentially reducing these side effects by focusing on a specific part of the immune pathway. Researchers are excited about this treatment because it promises a more precise intervention, which could lead to better outcomes for patients with fewer unwanted effects.
What is the effectiveness track record for ritlecitinib in treating alopecia areata?
Studies have shown that ritlecitinib effectively treats severe alopecia areata (AA), a condition that causes hair loss. In a major study, patients who had lost at least 25% of their scalp hair experienced positive results with ritlecitinib. About 73% of these patients completed 24 weeks of treatment and showed noticeable improvement. Several countries have approved the medication based on these findings. Research indicates that ritlecitinib is both effective and safe for long-term use in adults and teenagers with AA. Participants in this trial will receive ritlecitinib to further evaluate its effectiveness and safety.14567
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ritlecitinib according to the approved product label and standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ritlecitinib
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Real-world efficacy of ritlecitinib in treating alopecia areata ...
A total of 89 patients were included in the efficacy and safety analyses. Among these, 65 (73.0%) and 22 (24.7%) patients completed 24 and 36 weeks of ...
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.
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.
Effectiveness and tolerability of ritlecitinib in children with ...
Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial
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 ...
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 ...
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