A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up)

AbbVie

Status and phase: Invitation-only; Phase 3

Conditions: Vitiligo

Treatments: Drug: Upadacitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06118411

M19-044

2023-506195-27-00 (Other Identifier)

Details and patient eligibility

About

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. 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 be in one treatment arm where they all receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each study (540 participants total) at approximately 90 sites worldwide.

In 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.

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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540 participants in 6 patient groups, including a placebo group

Study 1, Period A: Group 1

Experimental group

Description:

Participants will receive upadacitinib 15 mg once a day for 48 weeks.

Treatment:

Drug: Upadacitinib

Study 2, Period A: Group 1

Experimental group

Description:

Participants will receive upadacitinib 15 mg once a day for 48 weeks.

Treatment:

Drug: Upadacitinib

Study 1, Period A: Group 2

Placebo Comparator group

Description:

Participants will receive placebo once daily for 48 weeks.

Treatment:

Drug: Placebo

Study 2, Period A: Group 2

Placebo Comparator group

Description:

Participants will receive placebo once a day for 48 weeks.

Treatment:

Drug: Placebo

Study 1, Period B: Extension Period

Experimental group

Description:

Participants will receive upadacitinib 15 mg once daily for 112 weeks.

Treatment:

Drug: Upadacitinib

Study 2, Period B: Extension Period

Experimental group

Description:

Participants will receive upadacitinib 15 mg once daily for 112 weeks.

Treatment:

Drug: Upadacitinib