Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Last updated: February 19, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hair Loss

Alopecia

Treatment

Ritlecitinib

Clinical Study ID

NCT06531109
B7981105
  • Ages > 12
  • All Genders

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 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.

Eligibility Criteria

Inclusion

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 thedecision to enroll a patient in this study.

  3. Evidence of a personally signed and dated informed consent document indicating thatthe patient (or a legally acceptable representative) has been informed of allpertinent aspects of the study. Following receipt of oral and written informationabout the trial, the adolescent (depending on local institutional reviewboard/independent ethics committee requirements) must provide assent, and one orboth (according to local regulations) parents or guardians of the child must providesigned informed consent before any study-related activity is carried out.

  4. Patients, who in the opinion of the investigator, are willing and able to complywith regular clinic visits as per standard practice at the site and agree tocomplete PRO questionnaires and other patient completed questions.

Exclusion

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 scarringalopecia, telogen effluvium).

  2. Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalppsoriasis, dermatitis, etc.) or other active systemic diseases that may cause hairloss (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 thestudy, site staff otherwise supervised by the investigator, and their respectivefamily.

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: Ritlecitinib
Phase:
Study Start date:
August 07, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • C2 Research Center

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

    Fremont, California 94538
    United States

    Site Not Available

  • Rao Dermatology

    Fresno, California 93720
    United States

    Site Not Available

  • Cura Clinical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Southern California Clinical Research

    Santa Ana, California 92701
    United States

    Site Not Available

  • Dermatology of Boca

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Pediatric Skin Research,LLC

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Suncoast Skin Solutions

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Skin Research of South Florida LLC

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Kindred Hair and Skin Center

    Marriottsville, Maryland 21104
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Michigan Dermatology Institute

    Waterford, Michigan 48328
    United States

    Active - Recruiting

  • Twin Cities Dermatology Center

    Minneapolis, Minnesota 55416
    United States

    Active - Recruiting

  • NW Dermatology Institute

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Epiphany Dermatology

    Southlake, Texas 76092
    United States

    Site Not Available

  • Frontier Dermatology

    Mill Creek, Washington 98012
    United States

    Site Not Available

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