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B7981040 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501668-16-00
Acronym
B7981040
Enrollment
81
Registered
2023-04-04
Start date
2023-06-26
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

NON SEGMENTAL VITILIGO

Brief summary

Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities

Detailed description

Response based on F-VASI75 at Weeks 24 and 36, Response based on T-VASI50 at Weeks 24, 36, and 52, % CFB in F-VASI at Weeks 24, 36, and 52., % CFB in T-VASI at Weeks 24, 36, and 52., Response based on improvement in PGIS-Fb at Weeks 24, 36, and 52, Response based on improvement in PGIS-Vc at Weeks 24, 36, and 52

Interventions

DRUGDEXAMETHASONE
DRUGplacebo for the PF-06651600 50mg

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities

Secondary

MeasureTime frame
Response based on F-VASI75 at Weeks 24 and 36, Response based on T-VASI50 at Weeks 24, 36, and 52, % CFB in F-VASI at Weeks 24, 36, and 52., % CFB in T-VASI at Weeks 24, 36, and 52., Response based on improvement in PGIS-Fb at Weeks 24, 36, and 52, Response based on improvement in PGIS-Vc at Weeks 24, 36, and 52

Countries

Bulgaria, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026