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Ritlecitinib

Phase 3

Stable Nonsegmental Vitiligo | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Mar 27, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment2,178
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06072183A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2PHASE3 ACTIVE NOT_RECRUITING 1,571 — — Nov 8, 2023Jul 30, 2027Mar 27, 2026228 United States, Australia +16
NCT05583526A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) TranquilloPHASE3 COMPLETED 607 — — Dec 1, 2022Feb 5, 2026Feb 27, 2026115 United States, Australia +13
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Study Endpoints
Primary Endpoints
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52
52 Weeks

Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)

Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
52 Weeks

Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.
Baseline through 108 weeks

To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo

Incidence of Clinically significant laboratory abnormalities.
Baseline through 108 weeks
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52
Week 52

Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities
Baseline through Week 52

Safety and tolerability of ritlecitinib in participants with nonsegmental vitiligo

Secondary Endpoints
Response based on F-VASI75 at 24 and 36 weeks
24 and 36 Weeks
US-Only: Response based on T-VASI50 at 24 and 36 weeks
24 and 36 weeks
Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
Week 24, 36 and week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1- Ritlecitinib 100 milligrams (mg)EXPERIMENTALRandomized to Ritlecitinib 100 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 2- Ritlecitinib 50mgEXPERIMENTALRandomized to Ritlecitinib 50 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 3- PlaceboPLACEBO_COMPARATORRandomized to Placebo QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 4- Ritlecitinib 100mgEXPERIMENTALNon-randomized open-label Ritlecitinib 100mg QD for 52 weeks.
Ritlecitinib 50 mgEXPERIMENTALRitlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
PlaceboPLACEBO_COMPARATORPlacebo (placebo arm; approximately 200 participants)
Interventions
NameTypeDescription
RitlecitinibDRUG100mg Capsule
PlaceboDRUGMatching capsule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites228

Inclusion Criteria: 1. Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening. • Meeting reproductive criteria for female participants. Disease Characteristics: 2. Eligible participants must have at both Scr...

Countries:United StatesAustraliaBelgiumBulgariaCanadaChinaGermanyHungaryItalyJapanMexicoPolandPuerto RicoSlovakiaSpainTaiwanTurkey (Türkiye)United KingdomSouth AfricaSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06072183primaryCompletionDate: changed
LOWMay 24, 2026NCT06072183studyFirstPostDate: changed
MEDIUMApr 8, 2026NCT05583526TRIAL_REMOVED: changed
MEDIUMApr 8, 2026NCT05583526TRIAL_REMOVED: changed