Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531109
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESTO
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 patients 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 2b3 study ALLEGRO 2b3 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
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 2b3 study ALLEGRO 2b3 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: