Trial Search Results

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

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. Adverse effects and change in disease activity will be assessed.

Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide.

Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: Upadacitinib
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Clinical diagnosis of non-segmental vitiligo (NSV) and no segmental or localized
   vitiligo.

   - Participants with all of the following at Screening and Baseline.

      - Visits: ≥ 0.5 F-VASI and ≥ 5 total vitiligo area scoring index (T-VASI).

      - Participants who have had prior exposure to immunomodulatory biologic therapy,
      for any indications, but discontinued the biologic therapy prior to the first
      dose of study drug. Recommended washout periods for biologic therapies include ≥
      4 weeks for etanercept; ≥ 8 weeks for adalimumab, infliximab, certolizumab,
      golimumab, abatacept, tocilizumab, and ixekizumab; ≥ 16 weeks for secukinumab;
      and ≥ 12 weeks for ustekinumab. For biologic therapies not specified, therapies
      must be discontinued at least 5 times the mean terminal elimination half-life of
      a drug or 3 months prior to Baseline, whichever is longer.

Exclusion Criteria:

   - Participants with segmental or localized vitiligo.

   - Participants with other skin conditions that would interfere with evaluation of
   vitiligo, participants with uncontrolled thyroid disease, and participants with > 33%
   leukotrichia on the face or > 33% leukotrichia on the body (including face).

   - Participants previously treated with any topical or systemic janus kinase (JAK)
   inhibitor or permanent skin bleaching agents.

   - Participants treated with any systemic vitiligo therapy (e.g., methotrexate,
   mycophenolate mofetil, corticosteroids), supplemental vitiligo therapy
   (antioxidants/vitamins/herbal medicine/traditional Chinese medicine), and/or topical
   vitiligo therapy including permanent or temporary tattoos within a minimum of 30 days
   prior to the first dose of study drug (Note: Camouflage and makeup may be used).

   - Participants treated with any phototherapy, including excimer (or other forms of laser
   therapy), within a minimum of 12 weeks prior to the first dose of study drug.

   - Participants have history of malignancy other than successfully treated non-melanoma
   skin cancer (NMSC) or localized carcinoma in situ of the cervix.

   - Recent (within past 6 months) cerebrovascular accident, myocardial infarction,
   coronary stenting, and aorto-coronary bypass surgery;

   - History of an organ transplant which requires continued immunosuppression;

   - History of gastrointestinal (GI) perforation (other than due to appendicitis or
   mechanical injury), diverticulitis, or significantly increased risk for GI perforation
   per investigator judgment;

   - Conditions that could interfere with drug absorption including but not limited to
   short bowel syndrome or gastric bypass surgery; subjects with a history of gastric
   banding/segmentation are not excluded;

   - Uncontrolled thyroid disease;

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting