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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
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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