Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118411
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-28
First Post:
2023-11-01
Brief Title:
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy Safety and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Viti-Up
Brief Summary:
Vitiligo is a common chronic autoimmune disease that causes the bodys 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506195-27-00 | OTHER | EU CT | None |