A clinical study to evaluate the safety and benefit of upadacitinib in patients with Vitiligo.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose- Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Non-Segmental Vitiligo

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000081-15-FR

Enrollment

160

Registered

2021-06-01

Start date

2021-08-24

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Vitiligo MedDRA version: 21.1 Level: PT Classification code 10047642 Term: Vitiligo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: UPADACITINIB CAS Number: 2050057-56-0 Current Sponsor code: ABT-494 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (male or female) =18 to 65 years of age Documented clinical diagnosis of non-segmental vitiligo (NSV) No segmental or localized vitiligo. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Subjects have been previously been treated with any topical or systemic JAK inhibitor. Subjects must not have previously been treated with any permanent skin bleaching agents Subjects must not have been treated with any topical vitiligo therapy including permanent and temporary tattoos within a minimum of 30 days prior to the first dose of study drug. (Note: Camouflage and makeup may be used). Subjects have history of malignancy other than successfully treated NMSC or localized carcinoma in situ of the cervix.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the safety and efficacy of upadacitinib for the treatment of adult subjects with NSV.;Secondary Objective: Not applicable ;Primary end point(s): 1. The primary endpoint is the percent change from Baseline in F-VASI ;Timepoint(s) of evaluation of this end point: Week 24	—

Secondary

Measure	Time frame
Secondary end point(s): 1.Achievement of F-VASI 75 (= 75% improvement in F-VASI from Baseline) 2.Achievement of F-VASI 50 (= 50% improvement in F-VASI from Baseline) 3.Achievement of total Vitiligo Area Scoring Index (T-VASI) 50 (= 50% improvement in T-VASI from Baseline) 4.Percent change from Baseline in T-VASI 5.Change from Baseline in the vitiligo quality-of-life (VitiQoL) instrument total score ;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Secondary end point(s): 1.Achievement of F-VASI 75 (= 75% improvement in F-VASI from Baseline) 2.Achievement of F-VASI 50 (= 50% improvement in F-VASI from Baseline) 3.Achievement of total Vitiligo Area Scoring Index (T-VASI) 50 (= 50% improvement in T-VASI from Baseline) 4.Percent change from Baseline in T-VASI 5.Change from Baseline in the vitiligo quality-of-life (VitiQoL) instrument total score ;Timepoint(s) of evaluation of this end point: Week 24

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Countries

Canada, France, Japan, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com+441628 561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026