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

Non-Segmental Vitiligo Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927975
• Other study ID #: M19-051
• Secondary ID: 2021-000081-15
• Status: Completed
• Phase: Phase 2
• Start date: June 16, 2021
• Est. completion date: August 29, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: August 29, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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;

Related Conditions & MeSH terms

• Non-Segmental Vitiligo
• Vitiligo

Intervention

Drug:
• Upadacitinib
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
Canada	Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388	Québec	Quebec
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 228403	Surrey	British Columbia
Canada	Research Toronto /ID# 228401	Toronto	Ontario
Canada	K. Papp Clinical Research /ID# 228877	Waterloo	Ontario
Canada	Wiseman Dermatology Research /ID# 228410	Winnipeg	Manitoba
France	Hopital Saint-Andre /ID# 228193	Bordeaux	Gironde
France	Hopital Henri Mondor /ID# 228198	Creteil
France	HCL - Hopital Edouard Herriot /ID# 228194	Lyon	Rhone
France	Chu de Nice-Hopital L'Archet Ii /Id# 228192	Nice	Alpes-Maritimes
France	CHU Toulouse - Hopital Larrey /ID# 228196	Toulouse
Japan	Nippon Medical School Hospital /ID# 230361	Bunkyo-ku	Tokyo
Japan	Yamanashi Prefectural Central Hospital /ID# 229441	Kofu-shi	Yamanashi
Japan	Nagoya City University Hospital /ID# 228725	Nagoya shi	Aichi
Japan	Tokyo Medical University Hospital /ID# 230288	Shinjuku-ku	Tokyo
Japan	Yamagata University Hospital /ID# 230362	Yamagata-shi	Yamagata
United States	Bellaire Dermatology Associates /ID# 228004	Bellaire	Texas
United States	Clearlyderm Dermatology /ID# 227993	Boca Raton	Florida
United States	Tufts Medical Center /ID# 228087	Boston	Massachusetts
United States	Medical University of South Carolina /ID# 228067	Charleston	South Carolina
United States	Michigan Center for Research Company /ID# 228054	Clarkston	Michigan
United States	Remington-Davis Clinical Research /ID# 229401	Columbus	Ohio
United States	Hamzavi Dermatology /ID# 228056	Fort Gratiot	Michigan
United States	University of Texas Health Science Center at Houston /ID# 229399	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 227996	Indianapolis	Indiana
United States	University of California Irvine /ID# 229390	Irvine	California
United States	New Horizon Research Center /ID# 229403	Miami	Florida
United States	International Clinical Research - Tennessee LLC /ID# 228059	Murfreesboro	Tennessee
United States	Virginia Clinical Research, Inc. /ID# 228050	Norfolk	Virginia
United States	Park Avenue Dermatology, PA /ID# 229400	Orange Park	Florida
United States	Oregon Dermatology and Research Center /ID# 228007	Portland	Oregon
United States	Oregon Medical Res Center PC /ID# 228073	Portland	Oregon
United States	Stanford University /ID# 228000	Redwood City	California
United States	ForCare Clinical Research /ID# 228010	Tampa	Florida
United States	Essential Medical Research, LLC /ID# 228074	Tulsa	Oklahoma
United States	UMass Chan Medical School /ID# 228066	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	At 24 weeks
Secondary	Percentage of Participants Achieving F-VASI 75 (= 75% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	At 24 weeks
Secondary	Percentage of Participants Achieving F-VASI 50 (= 50% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	At 24 weeks
Secondary	Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (= 50% Improvement in T-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	At 24 weeks
Secondary	Percent Change From Baseline in T-VASI	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	At 24 weeks
Secondary	Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score	The VitiQoL is a validated questionnaire used in clinical trials to assess stigma-related vitiligo impacts. The VitiQoL uses subject-elicited social, affective, and behavior items, asking the subject's appraisal of the vitiligo-related impacts over the last month. Fifteen items are scored on a 7-point scale ranging from 0 ("Not at all") to 6 ("All of the time"). Item scores (0 to 6) are summed to provide a total score range of 0 to 90; higher scores indicate greater impairment of quality of life (QoL).	At 24 weeks

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.