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Ritlecitinib higher dose

Phase 3

Severe Alopecia Areata | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Apr 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment365
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07029828A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.PHASE3 RECRUITING 140 — — Sep 10, 2025Jun 26, 2030Apr 28, 202641 United States, China +4
NCT07029711A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia AreataPHASE3 RECRUITING 225 — — Jul 31, 2025May 18, 2027Mar 30, 202680 United States, Canada +8
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (AEs).
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.
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).
For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20.
Week 24

The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10.
Week 24

The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Secondary Endpoints
Proportion of participants achieving absolute Severity of Alopecia Tool (SALT) score ≤10.
Months 3,6,9,12,15,18,21,24,27,30,33 and 36.
Proportion of participants achieving absolute SALT score ≤20.
Months 3,6,9,12,15,18,21,24,27,30,33 and 36.
Change from baseline (CFB) in SALT score.
Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ritlecitinib higher doseEXPERIMENTALParticipants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
Ritlecitinib lower doseEXPERIMENTALParticipants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
PlaceboPLACEBO_COMPARATORParticipants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.
Interventions
NameTypeDescription
Ritlecitinib higher doseDRUGStudy intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Ritlecitinib lower doseDRUGStudy intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
PlaceboDRUGStudy intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
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Eligibility Criteria
Age Range6 Years — 14 Years
SexALL
Healthy VolunteersNo
Study Sites41

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 ...

Countries:United StatesChinaCzechiaFranceJapanPolandCanadaItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07029711primaryCompletionDate: changed
LOWMay 26, 2026NCT07029828primaryCompletionDate: changed
LOWMay 24, 2026NCT07029711studyFirstPostDate: changed
LOWMay 24, 2026NCT07029828studyFirstPostDate: changed