Clinical trial NCT04927975: Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Segmental Vitiligo
Keywords: Vitiligo
Non-segmental vitiligo (NSV)
Upadacitinib
ABT-494
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 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;

Primary outcomes:
measure: Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in T-VASI at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine /ID# 229390
state: California
city: Redwood City
country: United States
facility: Stanford University /ID# 228000
state: California
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology /ID# 227993
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center /ID# 229403
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA /ID# 229400
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 228010
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 227996
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center /ID# 228087
state: Massachusetts
city: Worcester
country: United States
facility: Duplicate_UMass Chan Medical School /ID# 228066
state: Massachusetts
city: Clarkston
country: United States
facility: Duplicate_Michigan Center for Research Company /ID# 228054
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology /ID# 228056
state: Michigan
city: Columbus
country: United States
facility: Remington-Davis Clinical Research /ID# 229401
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research, LLC /ID# 228074
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 228007
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 228073
state: Oregon
city: Charleston
country: United States
facility: Duplicate_Medical University of South Carolina /ID# 228067
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC /ID# 228059
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 228004
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston /ID# 229399
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc. /ID# 228050
state: Virginia
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 228403
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 228410
state: Manitoba
city: Toronto
country: Canada
facility: Research Toronto /ID# 228401
state: Ontario
city: Waterloo
country: Canada
facility: Duplicate_K. Papp Clinical Research /ID# 228877
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 228388
state: Quebec
city: Nice
country: France
facility: Chu de Nice-Hopital Larchet Ii /Id# 228192
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: Duplicate_Hopital Saint-Andre /ID# 228193
state: Gironde
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 228194
state: Rhone
city: Creteil
country: France
facility: Duplicate_Hopital Henri Mondor /ID# 228198
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 228196
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 228725
state: Aichi
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 230361
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 230288
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 230362
state: Yamagata
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital /ID# 229441
state: Yamanashi
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: