PF-06651600 for Alopecia Areata
(ALLEGRO-LT Trial)
Trial Summary
What is the purpose of this trial?
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for adults and adolescents (12 years and older) with alopecia areata, including severe forms like totalis and universalis. It's open to new participants with significant hair loss due to alopecia that started within the last 10 years, as well as those from prior related studies. People can't join if they have certain ear conditions, a history of some cancers or herpes infections, or recent serious infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 200 mg PF-06651600 daily for 1 month, followed by 50 mg daily for 59 months
Vaccine Sub-study
Evaluation of immune response to tetanus and meningococcal vaccines in patients after a minimum of 6 months of treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
- PF-06651600
- Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
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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