Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo

Active, not recruiting

• Conditions: Non-Segmental Vitiligo

• Registration Number: jRCT2031230663
• Lead Sponsor: AbbVie GK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

-Documented clinical diagnosis of non-segmented vitiligo(NSV). -At Screening and Baseline Visits, participants must satisfyat least 1 of the following criteria: -- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failedat least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or -- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have a signof actively progressing vitiligo; or -- >= 0.5 F-VASI and 10 <= T-VASI < 50.

Exclusion Criteria

-Segmental or localized vitiligo. -History of active skin disease other than vitiligo that couldinterfere with the assessment of vitiligo.

• 33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (includingthe face).

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI)50	week 48	50% Improvement in T-VASI From Baseline
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI)75	week 48	75% Improvement in F-VASI From Baseline

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving F-VASI 50	week48	50% Improvement in F-VASI From Baseline
Percentage of Participants Achieving T-VASI 75	week 48	75% Improvement in T-VASI From Baseline
Percentage of Participants Achieving Patient Global Impression of Severity of Vitiligo Sun Sensitivity Score of "Not Sensitive at All (0)" or "Mildly Sensitive (1)"	week 48	For Participants with a Score of "Moderately Sensitive (2)" or Higher at Baseline
Percentage of Participants Achieving Patient Global Impression of Noticeability(PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)"	week 48	For Participants with a Score of "Moderately Noticeable (2)" or "Very Noticeable (3)"at Baseline
Percentage of Participants Achieving F-VASI 75	week 24	75% Improvement in F-VASI From Baseline
Percentage of Participants Achieving F-VASI 90	week 48	90% Improvement in F-VASI From Baseline
Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40	week 48	40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline (Study 1 Only)