Recruiting

Ritlecitinib

Sponsor:

Pfizer

Code:

NCT06531109

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Ritlecitinib

Study Details

Brief 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 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.

Conditions

Alopecia Areata

Study ID

NCT06531109

Start date

Aug 7, 2024

Status verified date

Jul, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Apr 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male and female patients aged >12 years at baseline.
2. Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
4. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.

Exclusion Criteria:

1. Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium).
2. Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
3. Patients previously treated with ritlecitinib or other JAK inhibitors.
4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Alopecia Areata (AA) patients treated with ritlecitinib

Interventions

Ritlecitinib

As provided in the real world practice.

Primary outcome measure

  • Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24 [ Time Frame: 24 weeks from initiation of the treatment ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

C2 Research Center

Recruiting

Montgomery, Alabama, United States, 36117

CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

Recruiting

Fremont, California, United States, 94538

Rao Dermatology

Recruiting

Fresno, California, United States, 93720

Cura Clinical Research

Recruiting

Oxnard, California, United States, 93030

Southern California Clinical Research

Recruiting

Santa Ana, California, United States, 92701

Dermatology of Boca

Recruiting

Boca Raton, Florida, United States, 33431

Pediatric Skin Research,LLC

Recruiting

Coral Gables, Florida, United States, 33146

Suncoast Skin Solutions

Recruiting

Jacksonville, Florida, United States, 32256

University of Miami

Recruiting

Miami, Florida, United States, 33136

Skin Research of South Florida LLC

Recruiting

Miami, Florida, United States, 33173

Kindred Hair and Skin Center

Recruiting

Marriottsville, Maryland, United States, 21104

Brigham & Women's Hospital/Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02115

Oakland Hills Dermatology

Recruiting

Auburn Hills, Michigan, United States, 48326

Michigan Dermatology Institute

Recruiting

Waterford, Michigan, United States, 48328

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Hickory Dermatology Research Center

Recruiting

Hickory, North Carolina, United States, 28602

NW Dermatology Institute

Recruiting

Portland, Oregon, United States, 97210

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Goodlettsville Dermatology Research

Recruiting

Goodlettsville, Tennessee, United States, 37072

Epiphany Dermatology

Recruiting

Southlake, Texas, United States, 76092

Raven Clinical Reseach

Recruiting

Fairfax, Virginia, United States, 22033

Raven Clinical Reseach

Recruiting

McLean, Virginia, United States, 22102

Frontier Dermatology

Recruiting

Mill Creek, Washington, United States, 98012

Raven Clinical Reseach

Recruiting

Burlington, Wisconsin, United States, 53105

More Information

Sponsor

Pfizer

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-23.