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
D
David Rosmarin
Primary Investigator
Recruiting
12-75 years
All
Phase
3
5 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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.
Detailed description of study
What will happen during the study?
- There will be 2 replicate studies running at the same time. In Period A,d 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.
- 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 higherburden 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: non-segmented vitiligo, NSV
-
Age: Between 12 Years - 75 Years
-
Gender: All
Inclusion Criteria
- Documented clinical diagnosis of non-segmented vitiligo (NSV).
- 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).
Updated on
11 Sep 2024.
Study ID: DERM-ABBVIE-M19-044, 22347
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
A copy of the message has been sent to your email
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
