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Upadacitinib for Vitiligo (Viti-Up Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented clinical diagnosis of non-segmented vitiligo (NSV).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Pivotal Trial

Summary

This trial will evaluate if the drug upadacitinib is safe and effective in treating vitiligo, a chronic autoimmune skin disease. 540 participants will be enrolled worldwide to receive either upadacitinib or a placebo in Period A, followed by upadacitinib in Period B.

Who is the study for?

Adults and adolescents with non-segmental vitiligo (NSV) who have tried at least one topical treatment without success or show signs of actively worsening vitiligo can join. They must have a certain amount of skin affected but not too much, as measured by specific scales.

What is being tested?

The trial is testing Upadacitinib, an oral tablet for autoimmune diseases, against a placebo to see if it's safe and effective for NSV. Participants are randomly assigned to get either the drug or placebo in Period A for 48 weeks; everyone gets Upadacitinib in Period B for 112 weeks.

What are the potential side effects?

Possible side effects include reactions typical of immune system medications like infections, liver issues, blood problems, allergies, and others that will be monitored through medical assessments and blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with non-segmented vitiligo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)

Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)

Secondary study objectives

EU/EMA Only: Percentage of Participants Achieving a Patient's Global Impression of Change-Vitiligo (PaGIC-V) of "Much better (1)"

EU/EMA Only: Percentage of Participants Achieving a Physician's Global Impression of Change - Vitiligo (PhGIC-V) of "Much better (1)"

EU/EMA Only: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: Study 2, Period B: Group 2 Open-Label Extension PeriodExperimental Treatment1 Intervention

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 II: Study 2, Period B: Group 1 Open-Label Extension PeriodExperimental Treatment1 Intervention

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 III: Study 2, Period A: Group 1Experimental Treatment1 Intervention

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

Group IV: Study 1, Period B: Group 2 Open-Label Extension PeriodExperimental Treatment1 Intervention

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 V: Study 1, Period B: Group 1 Open-Label Extension PeriodExperimental Treatment1 Intervention

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 VI: Study 1, Period A: Group 1Experimental Treatment1 Intervention

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

Group VII: (Optional) Study 3:Experimental Treatment2 Interventions

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

Group VIII: (Optional) Study 3, Period B: Open Label UpadacitinibExperimental Treatment2 Interventions

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

Group IX: Study 2, Period A: Group 2Placebo Group1 Intervention

Participants will receive placebo once daily for 48 weeks.

Group X: Study 1, Period A: Group 2Placebo Group1 Intervention

Participants will receive placebo once daily for 48 weeks.

Treatment

First Studied