CompletedPhase 3

Long-Term PF-06651600 for the Treatment of Alopecia Areata

United States, Argentina, Australia1,057 participantsStarted 2019-07-18

Plain-language summary

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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: * Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed. * De novo participants \>=12 to \<18 years of age: \>=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis * De novo participants \>=18 years of age and participants from Study B7931005 or B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: \>=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis * No evidence of terminal scalp hair regrowth within 6 months (de novo only) * Current episode of terminal scalp hair loss \<=10 years (de novo only) Exclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: * Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive * History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ * History of a single episode of disseminated herpes zoster o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response

Timeframe: Month 1

Trial details

NCT IDNCT04006457

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-25

Results submitted2025-06-24

View on ClinicalTrials.gov More Alopecia Areata trials