A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

Phase 1

• Conditions: Alopecia Areata; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2023-000824-12-Outside-EU/EEA
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Participants who are 6 to less than12 years old at the baseline visit.
2. A diagnosis of severe AA, including AT and AU, with =50% scalp hair loss due to AA (ie, a SALT score of =50) at both the Screening and Baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.A known congenital cause of AA, other systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc) or other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc).
2.Any present malignancies or history of malignancies, history of any lymphoproliferative disorder
3.History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.
4.Other medical or psychiatric condition (including recent [within the past year] or active suicidal ideation/behavior) that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
5.Not up to date with all age appropriate vaccines (including 2-dose vaccination for varicella) or vaccination with attenuated live vaccine within 6 weeks of first dose of study medicine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the Pharmacokinetics (PK) of ritlecitinib in children with AA 6 to <12 years of age;Secondary Objective: To further characterize the PK of ritlecitinib in children with AA 6 to <12 years of age <br><br>To characterize the pharmacodynamics (PD) of ritlecitinib in children with AA 6 to <12 years of age. <br><br>To evaluate the safety and tolerability of ritlecitinib in children with AA 6 to <12 years of age. <br><br>To assess the overall palatability, acceptability, and tolerability of the proposed age appropriate formulation in children with AA aged 6 to <12 years of <br>age. ;Primary end point(s): AUC24 on Day 7 ;Timepoint(s) of evaluation of this end point: Day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cmax, Tmax, CL/F, VZ/F and t½ on Day 7 <br><br>Change from baseline in interferon gamma IP-10 and lymphocyte subsets (T cell, B cell, and NK cells) on Day 7 <br><br>TEAE Treatment related AEs through Day 35<br><br>Serious AEs (SAEs) and AEs leading to discontinuation through Day 35<br><br><br> Clinically significant abnormalities in vital signs through Day 7<br><br> Clinically significant abnormalities in clinical laboratory Values through day 7<br><br>Taste assessment Day 1 and Day 7;Timepoint(s) of evaluation of this end point: Day 7<br>Through Day 35<br>Through Day 7<br>Day 1 and Day 7