Ritlecitinib for Alopecia Areata
(B7981028 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the long-term safety and effects of ritlecitinib, a new treatment for severe alopecia areata, a condition that causes significant hair loss. Participants will take a ritlecitinib capsule once daily at home to determine its effectiveness in addressing hair loss over a period of up to three years. The trial is open to individuals who have previously participated in specific Pfizer studies for alopecia areata and have lost at least half of their scalp hair due to the condition. Regular clinic visits and phone check-ins will monitor participants' 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.
Do I have to stop taking my current medications for 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 safe for people with alopecia areata, a condition that causes hair loss. In studies, most patients did not experience serious side effects. A combined safety review found that ritlecitinib is safe for use for up to 24 months in individuals aged 12 and older.
Ritlecitinib has already received FDA approval for treating severe alopecia areata in people aged 12 and up, indicating that the drug's safety has been thoroughly evaluated. While any treatment can have side effects, evidence so far suggests that ritlecitinib is a safe option for managing alopecia areata.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for alopecia areata, which often involve corticosteroids or immunosuppressants, Ritlecitinib is a promising new option because it targets specific pathways involved in the autoimmune process. Ritlecitinib is a Janus kinase (JAK) inhibitor, which means it works by blocking certain enzymes that contribute to inflammation and immune responses that attack hair follicles. This targeted mechanism could potentially offer a more effective and precise approach to treating alopecia, minimizing the broader side effects associated with traditional immunosuppressive therapies. Researchers are excited about Ritlecitinib because it represents a more focused strategy that could improve hair regrowth and quality of life for patients.
What evidence suggests that ritlecitinib might be an effective treatment for alopecia areata?
Research has shown that ritlecitinib offers promising results for people with alopecia areata, a condition that causes hair loss. In studies, patients who lost at least 25% of their scalp hair experienced significant regrowth with ritlecitinib over time. By week 12 of treatment, about 31.9% of patients with severe hair loss noticed a substantial improvement. In this trial, participants will receive either a higher dose or a lower dose of ritlecitinib. Ritlecitinib not only promotes hair regrowth but also reduces the emotional stress associated with alopecia areata. The treatment has proven to be both effective and safe for long-term use.678910
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 with severe alopecia areata who have finished a previous Pfizer study (B7981027 or B7981031). They should have significant hair loss and must have had varicella vaccination or immunity. The trial involves taking ritlecitinib, an oral medication, daily for up to 3 years.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ritlecitinib (higher or lower dose) or placebo for up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ritlecitinib
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