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

A Phase 3, Randomized, Placebo-Controlled, Double-BlindStudy to Evaluate the Efficacy, Safety, and Tolerability ofUpadacitinib 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

JPRN

Registry ID

JPRN-jRCT2031230663

Enrollment

450

Registered

2024-02-27

Start date

2023-12-19

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Non-Segmental Vitiligo

Interventions

Upadacitinib or Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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 = 0.5 F-VASI and 5 = 0.5 F-VASI and 10 <= T-VASI < 50.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Argentina, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, Slovakia, South Africa, South Korea, Spain, United States of America

Contacts

Public ContactPatients and HCP Contact

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026