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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06531109 | Registry Identifier | ClinicalTrials.gov |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alopecia Areata (AA) patients treated with ritlecitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib | Drug | As provided in the real world practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24 | SALT score is used to calculate the severity of alopecia areata. Physician calculate it by summing the percentage of hair loss in different regions of scalp. | 24 weeks from initiation of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status | Number/percentage of patients by age, sex, race, ethnicity, socio-economic status, area of residence, smoking status. Race and ethnicity variables will only be collected in participating countries where it is allowed. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The study population eligible for enrollment includes any adult and adolescent patients aged ≥12 years diagnosed with AA who receive at least one dose of ritlecitinib and satisfy the inclusion and exclusion criteria. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study. It will be allowed to enroll patients with previous use of topical JAK inhibitors only if there was at least a 4-week wash-out period prior to Baseline Visit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C2 Research Center | Recruiting | Montgomery | Alabama | 36117 | United States | |
| CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Demographic Characteristic of Participants: Date of Initial AA diagnosis | Baseline |
| Demographic Characteristics of participants: Duration of AA since diagnosis | Baseline |
| Demographic characteristics of participants: Duration of current AA Episode | Baseline |
| Demographic Characteristic of Participants: Predominant AA phenotype | Predominant AA phenotype (eg, patchy; ophiasis; AT; AU, etc | Baseline |
| Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score | SALT score is used to calculate the severity of alopecia areata. | Baseline |
| Clinical characteristics of participants: Eyelash Assessment (ELA) score | ELA score is used to calculate the severity of the involvement of eyelashes. | Baseline |
| Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score | EBA score is used to calculate the severity of the involvement of eyebrows | Baseline |
| Clinical Characteristics of participants: number of affected nails | Baseline |
| Clinical Characteristics of participants: Presence of Beard involvement | Determine whether the beard is affected or not. | Baseline |
| AA treatment history of participants: number of patients with prior AA treatments | Baseline |
| AA treatment history of participants: prior AA treatment class and route | Baseline |
| AA treatment history of participants: duration of prior therapy / frequency | baseline |
| AA treatment history of the participants: total number of prior AA treatments | Baseline |
| RW effectiveness of ritlecitinib: proportion of patients with <20 in SALT score | decrease in SALT score is the indicator of effectiveness. | week 24, 48, 72 and 96 |
| RW effectiveness of ritlecitinib: Proportion of patients with <10 | Decrease in SALT score is the indicator of effectiveness | week 24, 48, 72 and 96 |
| RW effectiveness of ritlecitinib: Change from baseline in SALT score | Decrease in SALT score is the indicator of effectiveness | week 24, 48, 72 and 96 |
| RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyebrow Assessment score (EBA) | Improvement in EBA score will indicate ritlecitinib effectiveness in eyebrow involvement. | Week 24, 48, 72 and 96 |
| RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyelashes Assessment Score (ELA) | Improvement in ELA score will indicate ritlecitinib effectiveness in eyebrow involvement. | Week 24, 48, 72 and 96 |
| RW effectiveness of ritlecitinib: proportion of patients with improvement from abnormal baseline in beard assessment and nail involvement | week 24, 48, 72 and 96 |
| Patient reported outcome: Evaluate ritlecitinib treatment satisfaction | Patient-reported satisfaction (P-sat) Response (defined as slightly, moderately, or very satisfied) at 24, 48, 72 and 96 weeks | week 24, 48, 72 and 96 |
| Patient reported outcome: Evaluate impression of hair growth | Patient Global Impression of Change (PGI-C) Response (defined as a score of moderate to severe), at 24, 48, 72 and 96 weeks | week 24, 48, 72 and 96 |
| Evaluate impact of ritlecitinib: Patient reported quality of life | Changes in AAPPO. · Improvement in hair loss AAPPO items 1-4, defined as a score of 0="no hair loss" or 1=" little hair loss", among patients with a baseline score 2-4 indicating moderate-complete hair loss. | week 24, 48, 72 and 96 |
| Evaluate impact of ritlecitinib: Patient reported quality of life | Change from baseline in emotional symptoms (ES) and activity limitations (AL) subscores | week 24, 48, 72 and 96 |
| Recruiting |
| Fremont |
| California |
| 94538 |
| United States |
| Rao Dermatology | Recruiting | Fresno | California | 93720 | United States |
| Cura Clinical Research | Recruiting | Oxnard | California | 93030 | United States |
| Stanford | Not yet recruiting | Redwood City | California | 94063 | United States |
| Southern California Clinical Research | Recruiting | Santa Ana | California | 92701 | United States |
| Dermatology of Boca | Recruiting | Boca Raton | Florida | 33431 | United States |
| Pediatric Skin Research,LLC | Recruiting | Coral Gables | Florida | 33146 | United States |
| Suncoast Skin Solutions | Recruiting | Jacksonville | Florida | 32256 | United States |
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
| Skin Research of South Florida LLC | Recruiting | Miami | Florida | 33173 | United States |
| Kindred Hair and Skin Center | Recruiting | Marriottsville | Maryland | 21104 | United States |
| Brigham & Women's Hospital/Harvard Medical School | Recruiting | Boston | Massachusetts | 02115 | United States |
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| Michigan Dermatology Institute | Recruiting | Waterford | Michigan | 48328 | United States |
| Twin Cities Dermatology Center | Active, not recruiting | Minneapolis | Minnesota | 55416 | United States |
| Hickory Dermatology Research Center | Recruiting | Hickory | North Carolina | 28602 | United States |
| NW Dermatology Institute | Recruiting | Portland | Oregon | 97210 | United States |
| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Goodlettsville Dermatology Research | Recruiting | Goodlettsville | Tennessee | 37072 | United States |
| Epiphany Dermatology | Recruiting | Southlake | Texas | 76092 | United States |
| Raven Clinical Reseach | Recruiting | Fairfax | Virginia | 22033 | United States |
| Raven Clinical Reseach | Recruiting | McLean | Virginia | 22102 | United States |
| Frontier Dermatology | Recruiting | Mill Creek | Washington | 98012 | United States |
| Raven Clinical Reseach | Recruiting | Burlington | Wisconsin | 53105 | United States |
| Beijing Tongren Hospital | Recruiting | Beijing | 100006 | China |
| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| The Fist Hospital of Jilin Province | Not yet recruiting | Changchun | 130021 | China |
| Xiangya Hospital, Central South University | Recruiting | Changsha | 410028 | China |
| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | 510091 | China |
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | 200040 | China |
| Shanghai Skin Disease Hospital | Recruiting | Shanghai | 200443 | China |
| Ch Victor Dupouy | Not yet recruiting | Argenteuil | 95100 | France |
| CHU de CAEN | Recruiting | Caen | 14033 | France |
| Chu Dijon Bourgogne | Not yet recruiting | Dijon | 21000 | France |
| CHU de Grenoble Alpes | Not yet recruiting | La Tronche | 38700 | France |
| CHU de Rennes Hôpital Pontchaillou | Not yet recruiting | Rennes | 35000 | France |
| Rouen University Hospital | Recruiting | Rouen | 76000 | France |
| Centre Sabouraud | Not yet recruiting | Paris | Île-de-France Region | 75010 | France |
| Hospital of the University of Occupational and Environmental Health | Recruiting | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| Kurume University Hospital | Recruiting | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Nagomi Dermatology Clinic | Recruiting | Ebina | Kanagawa | 243-0432 | Japan |
| Tohoku University Hospital | Not yet recruiting | Sendai | Miyagi | 908-8574 | Japan |
| Niigata University Medical & Dental Hospital | Recruiting | Niigata | Niigata | 951-8520 | Japan |
| Osaka Metropolitan University Hospital | Recruiting | Osaka | Osaka | 545-0051 | Japan |
| Hamamatsu University Hospital | Recruiting | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Teikyo University Hospital | Not yet recruiting | Itabashi-Ku | Tokyo | 173-8606 | Japan |
| Tokyo Medical University Hospital | Not yet recruiting | Shinjuku-Ku | Tokyo | 160-0023 | Japan |
| University Hospitals Sussex | Not yet recruiting | Brighton | EAST Sussex | BN2 3EW | United Kingdom |
| NHS Fife | Not yet recruiting | Dunfermline | FIFE | KY120SU | United Kingdom |
| Gloucestershire Hospitals NHS Foundation Trust | Recruiting | Gloucester | Gloucestershire | GL13PX | United Kingdom |
| Royal United Hospital Bath | Recruiting | Bath | BA1 3NG | United Kingdom |
| NHS Greater Glasgow and Clyde | Recruiting | Glasgow | G4 0SF | United Kingdom |
| Whipps Cross (Barts Health) | Recruiting | London | E11 1NR | United Kingdom |
| London North West University Healthcare Trust | Recruiting | London | NW10 7NS | United Kingdom |
| Chelsea and Westminster NHS Foundation Trust | Recruiting | London | SW10 9NH | United Kingdom |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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