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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Segmental Vitiligo

In brief

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.

Key facts

Study ID

NCT04927975

Run by

AbbVie

People needed

185

Starts

2021-06-30

Expected to finish

2023-08-29

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• University of California Irvine /ID# 229390 — Irvine, California, United States
• Stanford University /ID# 228000 — Redwood City, California, United States
• Clearlyderm Dermatology /ID# 227993 — Boca Raton, Florida, United States
• New Horizon Research Center /ID# 229403 — Miami, Florida, United States
• Park Avenue Dermatology, PA /ID# 229400 — Orange Park, Florida, United States
• ForCare Clinical Research /ID# 228010 — Tampa, Florida, United States
• Dawes Fretzin, LLC /ID# 227996 — Indianapolis, Indiana, United States
• Tufts Medical Center /ID# 228087 — Boston, Massachusetts, United States
• Duplicate_UMass Chan Medical School /ID# 228066 — Worcester, Massachusetts, United States
• Duplicate_Michigan Center for Research Company /ID# 228054 — Clarkston, Michigan, United States
• Hamzavi Dermatology /ID# 228056 — Fort Gratiot, Michigan, United States
• Remington-Davis Clinical Research /ID# 229401 — Columbus, Ohio, United States
• Essential Medical Research, LLC /ID# 228074 — Tulsa, Oklahoma, United States
• Oregon Dermatology and Research Center /ID# 228007 — Portland, Oregon, United States
• Oregon Medical Research Center /ID# 228073 — Portland, Oregon, United States
• Duplicate_Medical University of South Carolina /ID# 228067 — Charleston, South Carolina, United States
• International Clinical Research - Tennessee LLC /ID# 228059 — Murfreesboro, Tennessee, United States
• Bellaire Dermatology Associates /ID# 228004 — Bellaire, Texas, United States
• University of Texas Health Science Center at Houston /ID# 229399 — Houston, Texas, United States
• Virginia Clinical Research, Inc. /ID# 228050 — Norfolk, Virginia, United States
• Dr. Chih-ho Hong Medical Inc. /ID# 228403 — Surrey, British Columbia, Canada
• Wiseman Dermatology Research /ID# 228410 — Winnipeg, Manitoba, Canada
• Research Toronto /ID# 228401 — Toronto, Ontario, Canada
• Duplicate_K. Papp Clinical Research /ID# 228877 — Waterloo, Ontario, Canada
• Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388 — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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