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: Active, not recruiting; Phase 3

Conditions: Vitiligo

Treatments: Drug: Upadacitinib; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy; 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 (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.

Enrollment: 614 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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614 participants in 10 patient groups, including a placebo group

Study 1, Period A: Group 1

Experimental group

Description:

Participants will receive upadacitinib 15 mg once daily 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 1

Experimental group

Description:

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

Treatment:

Drug: Upadacitinib

Study 2, Period A: Group 2

Placebo Comparator group

Description:

Participants will receive placebo once daily for 48 weeks.

Treatment:

Drug: Placebo

Study 1, Period B: Group 1 Open-Label Extension Period

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Study 1, Period B: Group 2 Open-Label Extension Period

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Study 2, Period B: Group 1 Open-Label Extension Period

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Study 2, Period B: Group 2 Open-Label Extension Period

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

(Optional) Study 3, Period B: Open Label Upadacitinib

Experimental group

Description:

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

Treatment:

Other: NB-UVB (narrow-band ultraviolet B) Phototherapy

Drug: Upadacitinib

(Optional) Study 3:

Experimental group

Description:

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

Treatment:

Other: NB-UVB (narrow-band ultraviolet B) Phototherapy

Drug: Upadacitinib