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NCT06873945 · ClinicalTrials.gov registry record · Phase 3
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
A Phase 3 study of Alopecia Areata, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
- 20
- Study locations
NCT06873945: Recruiting Phase 3 study of Alopecia Areata, sponsored by Pfizer.
NCT06873945 is a Phase 3 study of Alopecia Areata that is actively recruiting participants, run by Pfizer. The registered enrollment target is 550 participants, below the 1,934-participant average among 26 other Alopecia Areata trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06873945, a Phase 3 study of Alopecia Areata, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose. This study is seeking participants who: * Are 12 years of age or older * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.
Primary Outcome
Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo
Conditions Studied
Interventions
- DRUG Ritlecitinib 50 mg
- DRUG Ritlecitinib 100 mg
- DRUG Placebo - 50 mg
- DRUG Placebo - 100 mg
Study Locations (20)
Florida
- Alliance for Multispecialty Research, LLC - Fort Myers
- Robert B. Pritt, DO, PA - Fort Myers
- Solutions Through Advanced Research - Jacksonville
- Pediatric Skin Research - Miami
- Skin Research of South Florida - Miami
- ForCare Clinical Research - Tampa
- Olympian Clinical Research - Tampa - Memorial Highway - Tampa
California
- Doc1 Healthcare Systems - Brea
- California Dermatology & Clinical Research Institute - Encinitas
- Marvel Clinical Research - Huntington Beach
- Southern California Clinical Research - Santa Ana
Indiana
- Indiana University Health University Hospital Adult Outpatient Center - Indianapolis
- Indiana University School of Medicine - Indiana CTSI Clinical Research Center - Indianapolis
- Sidney & Lois Eskenazi Health Center - Indianapolis
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis
Arkansas
- Burke Pharmaceutical Research - Hot Springs
Connecticut
- Brett King MD, LLC - Fairfield
Illinois
- Endeavor Health - Skokie
Iowa
- University of Iowa - Iowa City
Maryland
- Callender Center for Clinical Research - Glenn Dale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2027-03-09 |
| Phase | Phase 3 |
What NCT06873945 shows while recruiting
NCT06873945 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 1,934-participant average among 26 other Alopecia Areata trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 4 interventions - of which Ritlecitinib 50 mg is the first listed.
NCT06873945 names 20 study sites across 8 states, led by Florida, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT06873945 about?
NCT06873945 is a clinical study titled "A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata". The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 5...
What is the current status of trial NCT06873945?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2025-04-01. Estimated completion is 2027-03-09.
What conditions does trial NCT06873945 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT06873945?
The interventions under investigation include: Ritlecitinib 50 mg (DRUG), Ritlecitinib 100 mg (DRUG), Placebo - 50 mg (DRUG), Placebo - 100 mg (DRUG).
Who is sponsoring clinical trial NCT06873945?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06873945 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06873945's enrollment target sits among peer trials
550 10th of 26 higher than 17 of 26 other Alopecia Areata trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alopecia Areata trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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