A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031 - B7981028

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041250189

Enrollment

140

Registered

2026-02-26

Start date

2026-04-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alopecia Areata

Interventions

*Drug: Ritlecitinib higher dose -Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. *Drug: Ritlecitinib lower dose -Study intervention will be provided as o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031. 2.For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of >=50) at both the Screening and Baseline visits.

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria for participants originating from Study B7981027 with 30 Days between last dose in Study B7981027 and first visit of Study B7981028 1.During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol. 2.Any present malignancies or history of malignancies or lymphoproliferative disorders. 3.Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (AEs). [Time Frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).] Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. [Time Frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).]	—

Measure

Time frame

*Incidence of treatment-emergent adverse events (AEs). [Time Frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).] *Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. [Time Frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).]

—

Secondary

Measure	Time frame
Proportion of participants achieving absolute Severity of Alopecia Tool (SALT) score <=10. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] Proportion of participants achieving absolute SALT score <=20. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] Change from baseline (CFB) in SALT score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score in participants with an abnormal EBA at baseline. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score in participants with an abnormal ELA at baseline. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] Proportion of participants achieving Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] CFB in PROMIS Parent Proxy Anxiety Symptoms T-score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] CFB in Behavior Rating Inventory of Executive Function (BRIEF2) T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)). [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] CFB in Wechsler Intelligence Scale for Children Fifth Edition (WISC-V). [Time Frame: Baseline, Month 36]	—

Measure

Time frame

*Proportion of participants achieving absolute Severity of Alopecia Tool (SALT) score <=10. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *Proportion of participants achieving absolute SALT score <=20. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *Change from baseline (CFB) in SALT score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score in participants with an abnormal EBA at baseline. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score in participants with an abnormal ELA at baseline. [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *Proportion of participants achieving Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". [Time Frame: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *CFB in PROMIS Parent Proxy Anxiety Symptoms T-score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *CFB in Behavior Rating Inventory of Executive Function (BRIEF2) T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)). [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score. [Time Frame: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.] *CFB in Wechsler Intelligence Scale for Children Fifth Edition (WISC-V). [Time Frame: Baseline, Month 36]

—

Countries

China, Czechia, France, Japan, Poland, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026