Upadacitinib for Vitiligo
(Viti-Up Trial)

Recruiting in Palo Alto (17 mi)

+159 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed. Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3. In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with non-segmented vitiligo.

I have vitiligo that hasn't improved with certain creams or is getting worse.

Treatment Details

Interventions

Placebo (Other)
Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.