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Alopecia Areata (AA) patients treated with ritlecitinib for Alopecia Areata (PRESTO Trial)

N/A
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24, 48, 72 and 96
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Alopecia Areata

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24
Secondary study objectives
Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score
Clinical Characteristics of participants: Presence of Beard involvement
Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score
+11 more

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT05097716
10%
Nail disorder
10%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Ritlecitinib
Period 1: Tolbutamide
Period 2: Ritlecitinib + Tolbutamide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alopecia Areata (AA) patients treated with ritlecitinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib
2020
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,650 Previous Clinical Trials
17,742,813 Total Patients Enrolled
14 Trials studying Alopecia Areata
85,223 Patients Enrolled for Alopecia Areata
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,537 Previous Clinical Trials
14,914,001 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,117 Patients Enrolled for Alopecia Areata
~567 spots leftby Dec 2027