Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Public ClinicalTrials.gov record NCT06531109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06531109
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2024
- Primary completion
- Apr 14, 2028
- Completion
- Apr 14, 2028
- Last update posted
- Jul 22, 2026
2024 – 2028
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Recruiting |
| C2 Research Center | Montgomery | Alabama | 36117 | Recruiting |
| CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc | Fremont | California | 94538 | Recruiting |
| Rao Dermatology | Fresno | California | 93720 | Recruiting |
| Cura Clinical Research | Oxnard | California | 93030 | Recruiting |
| Stanford | Redwood City | California | 94063 | Not yet recruiting |
| Southern California Clinical Research | Santa Ana | California | 92701 | Recruiting |
| Dermatology of Boca | Boca Raton | Florida | 33431 | Recruiting |
| Pediatric Skin Research,LLC | Coral Gables | Florida | 33146 | Recruiting |
| Suncoast Skin Solutions | Jacksonville | Florida | 32256 | Recruiting |
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Skin Research of South Florida LLC | Miami | Florida | 33173 | Recruiting |
| Kindred Hair and Skin Center | Marriottsville | Maryland | 21104 | Recruiting |
| Brigham & Women's Hospital/Harvard Medical School | Boston | Massachusetts | 02115 | Recruiting |
| Oakland Hills Dermatology | Auburn Hills | Michigan | 48326 | Recruiting |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | Recruiting |
| Twin Cities Dermatology Center | Minneapolis | Minnesota | 55416 | Active, not recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Hickory Dermatology Research Center | Hickory | North Carolina | 28602 | Recruiting |
| NW Dermatology Institute | Portland | Oregon | 97210 | Recruiting |
| UPMC | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Goodlettsville Dermatology Research | Goodlettsville | Tennessee | 37072 | Recruiting |
| Epiphany Dermatology | Southlake | Texas | 76092 | Recruiting |
| Raven Clinical Reseach | Fairfax | Virginia | 22033 | Recruiting |
| Raven Clinical Reseach | McLean | Virginia | 22102 | Recruiting |
| Frontier Dermatology | Mill Creek | Washington | 98012 | Recruiting |
| Raven Clinical Reseach | Burlington | Wisconsin | 53105 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
Recently updated Alopecia Areata trials
Other public records listing Alopecia Areata. Sorted by last update posted; newest first. Not a recommendation.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06531109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Aug 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06531109 live on ClinicalTrials.gov.