Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib (NCT06531109)
PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
🩺 Plain-English Summary (8th-Grade Level)
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 patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- C2 Research Center — Montgomery, Alabama
- CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc — Fremont, California
- Rao Dermatology — Fresno, California
- Rao Dermatology — Fresno, California
- Cura Clinical Research — Oxnard, California
- Stanford — Redwood City, California
- Southern California Clinical Research — Santa Ana, California
- Dermatology of Boca — Boca Raton, Florida
- Pediatric Skin Research,LLC — Coral Gables, Florida
- Suncoast Skin Solutions — Jacksonville, Florida
- University of Miami — Miami, Florida
- Skin Research of South Florida LLC — Miami, Florida
- Kindred Hair and Skin Center — Marriottsville, Maryland
- Brigham & Women's Hospital/Harvard Medical School — Boston, Massachusetts
- Oakland Hills Dermatology — Auburn Hills, Michigan
- Michigan Dermatology Institute — Waterford, Michigan
- Twin Cities Dermatology Center — Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota
- Hickory Dermatology Research Center — Hickory, North Carolina
- NW Dermatology Institute — Portland, Oregon
- UPMC — Pittsburgh, Pennsylvania
- Goodlettsville Dermatology Research — Goodlettsville, Tennessee
- Epiphany Dermatology — Southlake, Texas
- Raven Clinical Reseach — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Alopecia Areata
- Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata — Birmingham, Alabama
- A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo — Northridge, California
- A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) — Northridge, California
- Alopecia Areata Registry — San Francisco, California
- Intralesional Cyclosporine for Alopecia Areata — Sacramento, California
- A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA) — Scottsdale, Arizona
Explore by condition: All Alopecia Areata clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.