Viti-Up

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Brief summary

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 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), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). 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. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4. 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 Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks. 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.

Interventional study

Status:
Active, not recruiting
Conditions:
Vitiligo
Enrollment:
614 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-044
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

12 Years and older.

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).

All the cities where the clinical studies are located

Calgary - T2J 7E1
Surrey - V3R 6A7
Hamilton - L8L 3C3
Waterloo - N2J 1C4
Québec - G1V 4X7
Fredericton - R3M 3Z4
Winnipeg - R3M 3Z4

Alberta

British Columbia

Manitoba

New Brunswick

More information about this study

clinicaltrials.gov