研究单位：[1]AbbVie[2]Advanced Research Associates - Glendale /ID# 259915,Glendale,Arizona,United States,85308[3]Alliance Dermatology and Mohs Center /ID# 259926,Phoenix,Arizona,United States,85032[4]Joseph Raoof Md,Inc /Id# 260055,Encino,California,United States,91436[5]University of California Irvine /ID# 260080,Irvine,California,United States,92697-1385[6]Vitiligo & Pigmentation Institute of Southern California /ID# 259970,Los Angeles,California,United States,90036-5679[7]Dermatology Research Associates /ID# 260056,Los Angeles,California,United States,90045[8]Stanford University /ID# 260081,Redwood City,California,United States,94063[9]Integrative Skin Science and Research /ID# 260060,Sacramento,California,United States,95815[10]University of California Davis Health /ID# 260062,Sacramento,California,United States,95817[11]Clinical Trials Research Institute /ID# 259910,Thousand Oaks,California,United States,91320-2130[12]Skin Care Research Boca Raton /ID# 260094,Boca Raton,Florida,United States,33486-2269[13]Apex Clinical Trials /ID# 260096,Brandon,Florida,United States,33511[14]Florida Academic Dermatology Center /ID# 259919,Coral Gables,Florida,United States,33134-5755[15]Direct Helpers Research Center /ID# 259932,Hialeah,Florida,United States,33012[16]Skin Care Research - Hollywood /ID# 260101,Hollywood,Florida,United States,33021-6748[17]Encore Medical Research /ID# 259963,Hollywood,Florida,United States,33021[18]GSI Clinical Research, LLC /ID# 259918,Margate,Florida,United States,33063[19]Life Clinical Trials /ID# 260097,Margate,Florida,United States,33063[20]Savin Medical Group, LLC /ID# 259968,Miami Lakes,Florida,United States,33014-2490[21]Advanced Clinical Research Institute /ID# 260058,Tampa,Florida,United States,33607[22]Encore Medical Research - Weston /ID# 260542,Weston,Florida,United States,33331[23]Cleaver Medical Group Dermatology /ID# 259925,Dawsonville,Georgia,United States,30534[24]DeNova Research /ID# 260611,Chicago,Illinois,United States,60611[25]Indiana University Health University Hospital /ID# 259974,Indianapolis,Indiana,United States,46202[26]Dawes Fretzin, LLC /ID# 260068,Indianapolis,Indiana,United States,46256[27]Tufts Medical Center /ID# 260088,Boston,Massachusetts,United States,02111-1552[28]Umass Memorial Medical Center /ID# 259921,Worcester,Massachusetts,United States,01605[29]Oakland Hills Dermatology /ID# 260602,Auburn Hills,Michigan,United States,48326[30]Great Lakes Research Group - Bay City /ID# 260600,Bay City,Michigan,United States,48706[31]Hamzavi Dermatology - Canton /ID# 260545,Canton,Michigan,United States,48187[32]Clarkston Dermatology /ID# 260069,Clarkston,Michigan,United States,48346[33]Henry Ford Medical Center - New Center One /ID# 260059,Detroit,Michigan,United States,48202-3046[34]Minnesota Clinical Study Center /ID# 260154,New Brighton,Minnesota,United States,55112[35]Vivida Dermatology- Flamingo /ID# 260609,Las Vegas,Nevada,United States,89119-5190[36]Schweiger Dermatology, P.C. /ID# 260152,New York,New York,United States,07044-2946[37]Icahn School of Medicine at Mount Sinai /ID# 259909,New York,New York,United States,10029[38]DermResearchCenter of New York, Inc. /ID# 259906,Stony Brook,New York,United States,11790[39]ClinOhio Research Services /ID# 260300,Columbus,Ohio,United States,43213-4440[40]Oregon Medical Research Center /ID# 259911,Portland,Oregon,United States,97201-5128[41]Oregon Dermatology and Research Center /ID# 259917,Portland,Oregon,United States,97210[42]Medical University of South Carolina /ID# 259916,Charleston,South Carolina,United States,29425[43]Bellaire Dermatology Associates /ID# 260044,Bellaire,Texas,United States,77401[44]Dermatology Treatment and Research Center /ID# 260078,Dallas,Texas,United States,75230[45]Innovative Dermatology - Plano /ID# 260628,Plano,Texas,United States,75024[46]Dermatology Clinical Research Center of San Antonio /ID# 260047,San Antonio,Texas,United States,78229[47]Progressive Clinical Research /ID# 260070,San Antonio,Texas,United States,78229[48]Buenos Aires Skin /ID# 259885,Ciudad Autonoma de Buenos Aire,Ciudad Autonoma De Buenos Aires,Argentina,1055[49]Instituto de Neumonologia y Dermatologia /ID# 259888,Ciudad Autonoma de Buenos Aire,Ciudad Autonoma De Buenos Aires,Argentina,1425[50]Psoriahue Med Interdisciplinar /ID# 259890,Ciudad Autonoma de Buenos Aire,Ciudad Autonoma De Buenos Aires,Argentina,1425[51]Instituto De Investigaciones Clínicas Córdoba /ID# 260371,Córdoba,Cordoba,Argentina,5000[52]Sanatorio 9 de Julio /ID# 260245,San Miguel de Tucumán,Tucuman,Argentina,4000[53]Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 259889,Buenos Aires,Argentina,1061[54]Cliniques Universitaires UCL Saint-Luc /ID# 259429,Woluwe-Saint-Lambert,Bruxelles-Capitale,Belgium,1200[55]Grand Hopital de Charleroi /ID# 259437,Charleroi,Hainaut,Belgium,6000[56]UZ Gent /ID# 259430,Gent,Oost-Vlaanderen,Belgium,9000[57]CHU de Liege /ID# 259427,Liege,Belgium,4000[58]Medical Center Cordis /ID# 259954,Pleven,Bulgaria,5800[59]Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 259955,Sofia,Bulgaria,1407[60]Diagnostic consultative center Focus-5 /ID# 259956,Sofiya,Bulgaria,1463[61]XX Diagnostic consultative center Sofia EOOD /ID# 259953,Sofiya,Bulgaria,1618[62]Dermatology Research Institute - Blackfoot Trail /ID# 261175,Calgary,Alberta,Canada,T2J 7E1[63]Dr. Chih-ho Hong Medical Inc. /ID# 260239,Surrey,British Columbia,Canada,V3R 6A7[64]Wiseman Dermatology Research /ID# 260236,Winnipeg,Manitoba,Canada,R3M 3Z4[65]Brunswick Dermatology Center /ID# 260237,Fredericton,New Brunswick,Canada,E3B 1G9[66]LEADER Research /ID# 260407,Hamilton,Ontario,Canada,L8L 3C3[67]Private Practice - Dr. Kim Papp Clinical Research /ID# 260406,Waterloo,Ontario,Canada,N2J 1C4[68]Centre de Recherche dermatologique du Quebec Metropolitain /ID# 260241,Québec,Quebec,Canada,G1V 4X7[69]Dre Angelique Gagne-Henley M.D. inc. /ID# 260238,Saint-Jerome,Quebec,Canada,J7Z 7E2[70]Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 260919,Beijing,Beijing,China,100730[71]Dermatology Hospital of Southern Medical University /ID# 260136,Guangzhou,Guangdong,China,510091[72]The Second Affiliated Hospital of Guangzhou Medical University /ID# 259929,Guangzhou,Guangdong,China,510260[73]Renmin Hospital of Wuhan University /ID# 260477,Wuhan,Hubei,China,430060[74]Second Affiliated Hospital of Xian Jiaotong University /ID# 260011,Xi''an,Shaanxi,China,710004[75]The First Affiliated Hospital of Xi''an Jiaotong University /ID# 260340,Xian,Shaanxi,China,710061[76]Shandong Dermatological Hospital /ID# 260338,Jinan,Shandong,China,250102[77]Huashan Hospital, Fudan University /ID# 259823,Shanghai,Shanghai,China,200040[78]Chengdu Second Municipal People''s Hospital /ID# 260423,Chengdu,Sichuan,China,610017[79]West China Hospital, Sichuan University /ID# 260624,Chengdu,Sichuan,China,610041[80]Tianjin Medical University General Hospital /ID# 259812,Tianjin,Tianjin,China,300052[81]First Affiliated Hospital of Kunming Medical University /ID# 260017,Kunming,Yunnan,China,650032
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.
