Suspended

Viti-UpUpadacitinib for Non-Segmental Vitiligo in Adults and Adolescents

Study Aim

The study aims to evaluate if Upadacitinib can improve skin pigmentation in adults and adolescents with non-segmental vitiligo by measuring changes in vitiligo area scoring index on the face and body.

What is being tested

Upadacitinib

+ NB-UVB (narrow-band ultraviolet B) Phototherapy

+ Placebo

DrugOther

Who is being recruted

Pigmentation Disorders+2

+ Skin Diseases

+ Vitiligo

Over 12 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorAbbVie

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 19, 2023

Actual date on which the first participant was enrolled.

This study is focused on understanding how safe and effective a drug called upadacitinib is for people with a skin condition known as non-segmental vitiligo (NSV), which is where the immune system mistakenly attacks skin cells that produce pigment. The study is significant because NSV affects many people and finding a reliable treatment can improve their quality of life by potentially restoring skin color. The trial involves adults and teenagers who are eligible for systemic therapy, meaning they may not have responded to other treatments. Participants in this study will either receive upadacitinib or a placebo, which is a substance with no active drug, taken as a tablet once a day for 48 weeks. After this period, all participants will receive upadacitinib for an additional 112 weeks. There is also an optional part of the study where some adults might receive upadacitinib along with a type of light therapy. Throughout the study, the effects of the treatments will be closely monitored through medical checks, blood tests, and questionnaires to track any side effects and changes in the vitiligo. Participants will need to visit a hospital or clinic regularly, which could be more demanding than their usual care routine.

Official TitleA 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

NCT06118411

Principal SponsorAbbVie

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

614 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pigmentation DisordersSkin DiseasesVitiligoSkin and Connective Tissue DiseasesHypopigmentation

Criteria

Inclusion Criteria: * Documented clinical diagnosis of non-segmented vitiligo (NSV). * At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria: * \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have failed at 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 sign of 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 could interfere with the assessment of vitiligo. * \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

10 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Open Label Upadacitinib Participants will receive upadacitinib 15 mg once daily for 112 weeks

Group II

Experimental

Participants will receive 15 mg upadacitinib once daily for 112 weeks and NB-UVB for up to 28 weeks

Group III

Experimental

Participants will receive upadacitinib 15 mg once daily for 48 weeks.

Group IV

Experimental

Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group 5

Experimental

Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group 6

Experimental

Participants will receive upadacitinib 15 mg once daily for 48 weeks.

Group 7

Experimental

Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group 8

Experimental

Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

Group 9

Placebo

Participants will receive placebo once daily for 48 weeks.

Group 10

Placebo

Participants will receive placebo once daily for 48 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 148 locations

Suspended

Advanced Research Associates - Glendale /ID# 259915

Glendale, United StatesOpen Advanced Research Associates - Glendale /ID# 259915 in Google Maps

Suspended

Alliance Dermatology and Mohs Center /ID# 259926

Phoenix, United States

Suspended

Private Practice - Dr. Tooraj Raoof /ID# 260055

Encino, United States

Suspended

University of California Irvine /ID# 260080

Irvine, United States

Suspended148 Study Centers