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NCT06531109 · ClinicalTrials.gov registry record
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
A clinical trial of Alopecia Areata, sponsored by Pfizer.
- Recruiting
- Registry status
- 850
- Enrollment target
- 20
- Study locations
NCT06531109: Recruiting study of Alopecia Areata, sponsored by Pfizer.
NCT06531109 is a study of Alopecia Areata that is actively recruiting participants, run by Pfizer. The registered enrollment target is 850 participants, below the 1,923-participant average among 26 other Alopecia Areata trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06531109, a study of Alopecia Areata, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- 850 participants
- Enrollment target
- 20
- Study locations
Study Summary
Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are: * Patchy alopecia (PA), as seen in 90% of clinical diagnoses * Alopecia totalis (AT), that affects all scalp hair * Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020). Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally. Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib. The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patien
Primary Outcome
SALT score is used to calculate the severity of alopecia areata. Physician calculate it by summing the percentage of hair loss in different regions of scalp.
Conditions Studied
Interventions
- DRUG Ritlecitinib
Study Locations (20)
California
- CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc - Fremont
- Rao Dermatology - Fresno
- Cura Clinical Research - Oxnard
- Stanford - Redwood City
- Southern California Clinical Research - Santa Ana
Florida
- Dermatology of Boca - Boca Raton
- Pediatric Skin Research,LLC - Coral Gables
- Suncoast Skin Solutions - Jacksonville
- University of Miami - Miami
- Skin Research of South Florida LLC - Miami
Michigan
- Oakland Hills Dermatology - Auburn Hills
- Michigan Dermatology Institute - Waterford
Alabama
- C2 Research Center - Montgomery
Maryland
- Kindred Hair and Skin Center - Marriottsville
Massachusetts
- Brigham & Women's Hospital/Harvard Medical School - Boston
Minnesota
- Twin Cities Dermatology Center - Minneapolis
North Carolina
- Hickory Dermatology Research Center - Hickory
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2028-03-31 |
What NCT06531109 shows while recruiting
NCT06531109 is an observational study that tracks outcomes without assigning an intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, below the 1,923-participant average among 26 other Alopecia Areata trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 1 intervention - of which Ritlecitinib is the first listed.
NCT06531109 names 20 study sites across 11 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT06531109 about?
NCT06531109 is a clinical study titled "Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib". Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on t...
What is the current status of trial NCT06531109?
This trial is currently recruiting. The enrollment target is 850 participants. The study started on 2024-08-07. Estimated completion is 2028-03-31.
What conditions does trial NCT06531109 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT06531109?
The interventions under investigation include: Ritlecitinib (DRUG).
Who is sponsoring clinical trial NCT06531109?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06531109 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alopecia Areata
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06531109's enrollment target sits among peer trials
850 9th of 26 higher than 18 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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