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NCT06531109Recruiting

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Pfizer

Start Date

8/7/2024

Completion Date

4/15/2028

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

Age Range: 12 years to No maximum

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.

Interventions

DRUG

Ritlecitinib

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Conditions

Alopecia Areata

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

C2 Research Center

Montgomery, Alabama 36117

United States

CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

Fremont, California 94538

United States

Rao Dermatology

Fresno, California 93720

United States

Rao Dermatology

Fresno, California 93720

United States

Cura Clinical Research

Oxnard, California 93030

United States

Stanford

Redwood City, California 94063

United States

Southern California Clinical Research

Santa Ana, California 92701

United States

Dermatology of Boca

Boca Raton, Florida 33431

United States

Pediatric Skin Research,LLC

Coral Gables, Florida 33146

United States

Suncoast Skin Solutions

Jacksonville, Florida 32256

United States

University of Miami

Miami, Florida 33136

United States

Skin Research of South Florida LLC

Miami, Florida 33173

United States

Kindred Hair and Skin Center

Marriottsville, Maryland 21104

United States

Brigham & Women's Hospital/Harvard Medical School

Boston, Massachusetts 02115

United States

Oakland Hills Dermatology

Auburn Hills, Michigan 48326

United States

Michigan Dermatology Institute

Waterford, Michigan 48328

United States

Twin Cities Dermatology Center

Minneapolis, Minnesota 55416

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Hickory Dermatology Research Center

Hickory, North Carolina 28602

United States

NW Dermatology Institute

Portland, Oregon 97210

United States

UPMC

Pittsburgh, Pennsylvania 15213

United States

Goodlettsville Dermatology Research

Goodlettsville, Tennessee 37072

United States

Epiphany Dermatology

Southlake, Texas 76092

United States

Raven Clinical Reseach

Fairfax, Virginia 22033

United States

Raven Clinical Reseach

McLean, Virginia 22102

United States

Frontier Dermatology

Mill Creek, Washington 98012

United States

Raven Clinical Reseach

Burlington, Wisconsin 53105

United States

Beijing Tongren Hospital

Beijing, 100006

China

Peking University First Hospital

Beijing, 100034

China

Peking University People's Hospital

Beijing, 100044

China

The Fist Hospital of Jilin Province

Changchun, 130021

China

The Fist Hospital of Jilin Province

Changchun, 130021

China

Xiangya Hospital, Central South University

Changsha, 410028

China

Dermatology Hospital of Southern Medical University

Guangzhou, 510091

China

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040

China

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040

China

Shanghai Skin Disease Hospital

Shanghai, 200443

China

University hospital of Bordeaux

Bordeaux, New Aquitaine 33000

France

Ch Victor Dupouy

Argenteuil, 95100

France

CHU de CAEN

Caen, 14033

France

Chu Dijon Bourgogne

Dijon, 21000

France

Chu Dijon Bourgogne

Dijon, 21000

France

CHU de Grenoble Alpes

La Tronche, 38700

France

CHU de Grenoble Alpes

La Tronche, 38700

France

Hôpital Saint Vincent de Paul

Lille, 59000

France

CHU de Rennes Hôpital Pontchaillou

Rennes, 35000

France

CHU de Rennes Hôpital Pontchaillou

Rennes, 35000

France

Rouen University Hospital

Rouen, 76000

France

Hôpital Larrey

Toulouse, 31059

France

Centre Sabouraud

Paris, Île-de-France Region 75010

France

Centre Sabouraud

Paris, Île-de-France Region 75010

France

A.O.U.C Policlinico de Bari

Bari, BA 70124

Italy

Istituto clinico Humanitas

Rozzano, Milan 20089

Italy

Irccs, Aoubo, Policlinico S.Orsola

Bologna, 40138

Italy

AO G. Rodolico - San Marco di Catania UOC DERMATOLOGIA

Catania, 95123

Italy

Policlinico Umberto I

Roma, 00161

Italy

Policlinico Tor Vergata

Rome, 00133

Italy

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka 807-8556

Japan

Kurume University Hospital

Kurume-shi, Fukuoka 830-0011

Japan

Nagomi Dermatology Clinic

Ebina, Kanagawa 243-0432

Japan

Tohoku University Hospital

Sendai, Miyagi 908-8574

Japan

Tohoku University Hospital

Sendai, Miyagi 908-8574

Japan

Niigata University Medical & Dental Hospital

Niigata, Niigata 951-8520

Japan

Osaka Metropolitan University Hospital

Osaka, Osaka 545-0051

Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka 431-3192

Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431

Japan

Teikyo University Hospital

Itabashi-Ku, Tokyo 173-8606

Japan

Teikyo University Hospital

Itabashi-Ku, Tokyo 173-8606

Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo 160-0023

Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo 160-0023

Japan

University Hospitals Sussex

Brighton, EAST Sussex BN2 3EW

United Kingdom

University Hospitals Sussex

Brighton, EAST Sussex BN2 3EW

United Kingdom

NHS Fife

Dunfermline, FIFE KY120SU

United Kingdom

NHS Fife

Dunfermline, FIFE KY120SU

United Kingdom

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire GL13PX

United Kingdom

Royal United Hospital Bath

Bath, BA1 3NG

United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, G4 0SF

United Kingdom

Whipps Cross (Barts Health)

London, E11 1NR

United Kingdom

London North West University Healthcare Trust

London, NW10 7NS

United Kingdom

Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH

United Kingdom