Clinical trial NCT06118411: A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Vitiligo
Keywords: Vitiligo
Non-Segmented Vitiligo
Viti-Up
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 614
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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 (NSV). Adverse effects and change in disease activity will be assessed.

Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3.

In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone.

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:

* Documented clinical diagnosis of non-segmented vitiligo (NSV).
* At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:

  * \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
  * \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have a sign of actively progressing vitiligo; or
  * \>= 0.5 F-VASI and 10 \<= T-VASI \< 50.

Exclusion Criteria:

* Segmental or localized vitiligo.
* History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
* \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).

Primary outcomes:
measure: Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
timeFrame: Week 48
measure: Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
timeFrame: Week 48
measure: Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
timeFrame: Week 24
measure: Percent Change from Baseline in F-VASI
timeFrame: Week 24
measure: Percent Change From Baseline in T-VASI
timeFrame: Week 48
measure: Percentage of Participants Achieving F-VASI 90 (≥ 90% Improvement in F-VASI From Baseline)
timeFrame: Week 48
measure: Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline)
timeFrame: Week 48
measure: Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 (≥ 40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline) (Study 1 Only)
timeFrame: Week 48
measure: EU/EMA Only: Percentage of Participants Achieving a Physician's Global Impression of Change - Vitiligo (PhGIC-V) of "Much better (1)"
timeFrame: At Week 48
measure: EU/EMA Only: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"
timeFrame: At Week 48
measure: EU/EMA Only: Percentage of Participants Achieving a Patient's Global Impression of Change-Vitiligo (PaGIC-V) of "Much better (1)"
timeFrame: At Week 48
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 259915
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center /ID# 259926
state: Arizona
city: Encino
country: United States
facility: Joseph Raoof Md,Inc /Id# 260055
state: California
city: Irvine
country: United States
facility: University of California Irvine /ID# 260080
state: California
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California /ID# 259970
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 260056
state: California
city: Redwood City
country: United States
facility: Stanford University /ID# 260081
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 260060
state: California
city: Sacramento
country: United States
facility: University of California Davis Health /ID# 260062
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 259910
state: California
city: Boca Raton
country: United States
facility: Skin Care Research Boca Raton /ID# 260094
state: Florida
city: Brandon
country: United States
facility: Apex Clinical Trials /ID# 260096
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center /ID# 259919
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center /ID# 259932
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 260101
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research /ID# 259963
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 259918
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials /ID# 260097
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC /ID# 259968
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 260058
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston /ID# 260542
state: Florida
city: Dawsonville
country: United States
facility: Cleaver Medical Group Dermatology /ID# 259925
state: Georgia
city: Chicago
country: United States
facility: DeNova Research /ID# 260611
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital /ID# 259974
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 260068
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center /ID# 260088
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 259921
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology /ID# 260602
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group - Bay City /ID# 260600
state: Michigan
city: Canton
country: United States
facility: Hamzavi Dermatology - Canton /ID# 260545
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Dermatology /ID# 260069
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One /ID# 260059
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center /ID# 260154
state: Minnesota
city: Las Vegas
country: United States
facility: Vivida Dermatology- Flamingo /ID# 260609
state: Nevada
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 260152
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 259909
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc. /ID# 259906
state: New York
city: Columbus
country: United States
facility: ClinOhio Research Services /ID# 260300
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 259911
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 259917
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 259916
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 260044
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center /ID# 260078
state: Texas
city: Plano
country: United States
facility: Innovative Dermatology - Plano /ID# 260628
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio /ID# 260047
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 260070
state: Texas
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Buenos Aires Skin /ID# 259885
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Neumonologia y Dermatologia /ID# 259888
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Psoriahue Med Interdisciplinar /ID# 259890
state: Ciudad Autonoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Instituto De Investigaciones Clínicas Córdoba /ID# 260371
state: Cordoba
city: San Miguel de Tucumán
country: Argentina
facility: Sanatorio 9 de Julio /ID# 260245
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 259889
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 259429
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi /ID# 259437
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent /ID# 259430
state: Oost-Vlaanderen
city: Liege
country: Belgium
facility: CHU de Liege /ID# 259427
city: Pleven
country: Bulgaria
facility: Medical Center Cordis /ID# 259954
city: Sofia
country: Bulgaria
facility: Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 259955
city: Sofiya
country: Bulgaria
facility: Diagnostic consultative center Focus-5 /ID# 259956
city: Sofiya
country: Bulgaria
facility: XX Diagnostic consultative center Sofia EOOD /ID# 259953
city: Calgary
country: Canada
facility: Dermatology Research Institute - Blackfoot Trail /ID# 261175
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 260239
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 260236
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center /ID# 260237
state: New Brunswick
city: Hamilton
country: Canada
facility: LEADER Research /ID# 260407
state: Ontario
city: Waterloo
country: Canada
facility: Private Practice - Dr. Kim Papp Clinical Research /ID# 260406
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 260241
state: Quebec
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 260238
state: Quebec
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 260919
state: Beijing
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University /ID# 260136
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 259929
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University /ID# 260477
state: Hubei
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xian Jiaotong University /ID# 260011
state: Shaanxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University /ID# 260340
state: Shaanxi
city: Jinan
country: China
facility: Shandong Dermatological Hospital /ID# 260338
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 259823
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Second Municipal People's Hospital /ID# 260423
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 260624
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 259812
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University /ID# 260017
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital /ID# 261005
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260626
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 259822
state: Zhejiang
city: Nice
country: France
facility: Chu de Nice-Hopital Larchet Ii /Id# 259442
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 259443
state: Gironde
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259446
state: Paris
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 259444
state: Rhone
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 259445
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 260153
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 260148
state: Brandenburg
city: Bonn
country: Germany
facility: MVZ Dermatologisches Zentrum Bonn GmbH /ID# 260287
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 260288
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 260293
state: Niedersachsen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 260147
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz /ID# 260151
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Private Practice - Dr. Abdou Zarzour /ID# 260290
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 260289
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 260294
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 260291
city: Debrecen
country: Hungary
facility: DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 260072
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 259852
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 259851
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 259850
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 259849
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 260420
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 259771
state: Roma
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 259772
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 260551
state: Aichi
city: Sakai-shi
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic /ID# 260555
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 261285
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 260550
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 260552
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 260553
state: Yamagata
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital /ID# 260554
state: Yamanashi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 260917
state: Daejeon Gwang Yeogsi
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 260836
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 260916
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 260880
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong /ID# 260879
state: Seoul Teugbyeolsi
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 259501
state: Noord-Brabant
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis /ID# 259696
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC /ID# 259676
state: Noord-Holland
city: Osielsko
country: Poland
facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 259690
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 260016
state: Malopolskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 259686
state: Malopolskie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne /ID# 261424
state: Malopolskie
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka /ID# 259691
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Osipowicz & Turkowski sp.z.o.o /ID# 259761
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia /ID# 260018
state: Mazowieckie
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 259753
state: Podlaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita /ID# 259752
state: Slaskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM /ID# 259757
state: Zachodniopomorskie
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra, EPE /ID# 259793
city: Leiria
country: Portugal
facility: Unidade Local de Saude da Regiao de Leiria, EPE /ID# 259789
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas /ID# 259788
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 259791
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral (SCB) Research Center /ID# 260100
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 260090
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 260092
city: Bratislava
country: Slovakia
facility: Derma therapy spol /ID# 260838
state: Bratislavsky Kraj
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava /ID# 260164
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 259371
state: Barcelona
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe /ID# 259376
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid /ID# 259377
state: Madrid
city: Granada
country: Spain
facility: Hospital Universitario Clinico San Cecilio /ID# 259374
city: Madrid
country: Spain
facility: Grupo Pedro Jaen /ID# 259375
city: Valencia
country: Spain
facility: Consorci Hospital General Universitario de Valencia /ID# 259372
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 259373
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: