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RECRUITING

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

NCT06531109 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 850 participants
Start Date 2024-08-07
Est. Completion 2028-03-31

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06531109

The ClinicalTrials.gov registry entry for NCT06531109 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06531109 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06531109?

The interventions under investigation include: Ritlecitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06531109?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial