Vitiligo
main-banner
Vitiligo
M19-044 Enrolling

Non-Segmental Vitiligo – Clinical Research for Adults and Adolescents


Treatment: Oral Age: 12 Years


Who can participate?

Adults and adolescents aged 12 or older are needed for a clinical trial conducted in Canada and the U.S.

 

Inclusion Criteria:

      • Adolescent subjects (≥ 12 and < 18 years of age) must have a body weight of ≥ 30 kg.
      • Have a documented clinical diagnosis of non-segmental vitiligo.
      • Must have no other active skin disease other than vitiligo that could interfere with the assessment of vitiligo.

 

Participant Info:

As a participant in our research trial, you will receive an oral investigational treatment (active study drug) or placebo at no cost. All study-related assessments will also be provided at no charge. In addition, you may be reimbursed for study-related expenses.

 

How long will the study last?

Study lasts for a duration of 106 weeks and involves about 20 visits to the study centre.


Participating Locations

COUNTRY
country-icon
Canada

Participating Experts

Dr. Kim Alexander Papp

Dermatologist

You May Also Be Interested In

Similar Trials

No Similar Trials Found

The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

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

ClinicalTrials.gov ID

NCT06118411

Sponsor

AbbVie

Study Description

  • 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 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.

  • Condition or Disease:

    Vitiligo

  • Intervention/Treatment:

    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Placebo
    Drug: Placebo
    Drug: Upadacitinib
    Drug: Upadacitinib
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    12 Years and older (Child)

  • Sexes Eligible for Study:

    All

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).


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



about-icon

Learn More About

Vitiligo

Learn More
2022 all rights reserved probity medical research inc
find a trial
filter trials
Skip to content