[M19-051] Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Yamazaki Hayato0 sites160 target enrollmentAugust 6, 2021

Conditionson-Segmental Vitiligo

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: on-Segmental Vitiligo
Sponsor: Yamazaki Hayato
Enrollment: 160
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 6, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yamazaki Hayato

Eligibility Criteria

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 Facial Vitiligo Area Scoring Index (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;