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A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506195-27-00
Acronym
M19-044
Enrollment
239
Registered
2024-03-26
Start date
2024-04-05
Completion date
Unknown
Last updated
2025-12-01

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

Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48, Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48

Detailed description

Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;, Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;, Percent change from Baseline in F-VASI at Week 24;, Percent change from Baseline in T-VASI at Week 48;, Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;, Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;, Achievement of PaGIC-V of "Much better (1)" at Week 48., Achievement of PhGIC-V of "Much better (1)" at Week 48;

Interventions

DRUGUpadacitinib

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48, Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48

Secondary

MeasureTime frame
Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;, Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;, Percent change from Baseline in F-VASI at Week 24;, Percent change from Baseline in T-VASI at Week 48;, Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;, Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;, Achievement of PaGIC-V of "Much better (1)" at Week 48., Achievement of PhGIC-V of "Much better (1)" at Week 48;

Countries

Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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