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Active, not recruiting No phase listed Observational

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

ClinicalTrials.gov ID: NCT06531109

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.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 2:40 PM EDT

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
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Pfizer
Industry
Enrollment
450 participants

Conditions and interventions

Interventions

Drug

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 7, 2024 (Actual)
Primary completion
Apr 15, 2028 (Estimated)
Completion
Apr 15, 2028 (Estimated)
Last update posted
Oct 6, 2026

2024 – 2028

United States locations

U.S. sites
28
U.S. states
16
U.S. cities
26
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
C2 Research Center Montgomery Alabama 36117 —
CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc Fremont California 94538 —
Rao Dermatology Fresno California 93720 —
Cura Clinical Research Oxnard California 93030 —
Stanford Redwood City California 94063 —
Southern California Clinical Research Santa Ana California 92701 —
Dermatology of Boca Boca Raton Florida 33431 —
Pediatric Skin Research,LLC Coral Gables Florida 33146 —
Suncoast Skin Solutions Jacksonville Florida 32256 —
University of Miami Miami Florida 33136 —
Skin Research of South Florida LLC Miami Florida 33173 —
University of Iowa Health Care Iowa City Iowa 52242 —
Kindred Hair and Skin Center Marriottsville Maryland 21104 —
Brigham & Women's Hospital/Harvard Medical School Boston Massachusetts 02115 —
Oakland Hills Dermatology Auburn Hills Michigan 48326 —
Michigan Dermatology Institute Waterford Michigan 48328 —
Twin Cities Dermatology Center Minneapolis Minnesota 55416 —
University of Minnesota Minneapolis Minnesota 55455 —
Hickory Dermatology Research Center Hickory North Carolina 28602 —
NW Dermatology Institute Portland Oregon 97210 —
UPMC Pittsburgh Pennsylvania 15213 —
Goodlettsville Dermatology Research Goodlettsville Tennessee 37072 —
Epiphany Dermatology Southlake Texas 76092 —
Raven Clinical Reseach Fairfax Virginia 22033 —
Raven Clinical Reseach McLean Virginia 22102 —
Frontier Dermatology Mill Creek Washington 98012 —
Raven Clinical Reseach Burlington Wisconsin 53105 —

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.

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 Oct 6, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06531109 live on ClinicalTrials.gov.

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