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

JRCT ID: jRCT2031230663

Registered date:27/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-Segmental Vitiligo
• Date of first enrollment: 27/02/2024
• Target sample size: 450
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Slovakia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,United States of America,Japan
• Study type: Interventional
• Intervention(s): Upadacitinib or Placebo

Outcome(s)

Primary Outcome

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

Secondary Outcome

Percentage of Participants Achieving F-VASI 50 ( 50% Improvement in F-VASIFrom Baseline) at week48.
Percent Change from Baseline in F-VASI at week24.
Percentage of Participants Achieving T-VASI 75 ( 75% Improvement in T-VASIFrom Baseline) at week 48.
Percentage of Participants Achieving F-VASI 75 ( 75% Improvement in F-VASIFrom Baseline) at week 24.
Percentage of Participants Achieving F-VASI 90 ( 90% Improvement in F-VASIFrom Baseline) at week 48.
Percentage of Participants Achieving Patient Global Impression of Severity of
Vitiligo Sun Sensitivity Score of "Not Sensitive at All (0)" or "Mildly Sensitive (1)"For Participants with a Score of "Moderately Sensitive (2)" or Higher at Baseline at week 48.
Percent Change From Baseline in T-VASI at week 48.
Percentage of Participants Achieving Patient Global Impression of Noticeability(PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)" For
Participants with a Score of "Moderately Noticeable (2)" or "Very Noticeable (3)"at Baseline at week 48.
Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 ( 40%
Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline)(Study 1 Only) at week 48.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Otani Tetsuya