Alopecia AreataPhase 3Up-AANCT06012240
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
A Phase 3 study testing Upadacitinib in people with Alopecia Areata, run by AbbVie at 272 sites in 28 countries.
Trial summary
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. Read more about this study
- Who is it for?
- Ages 12 to 63 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 272 sitesin 28 countries
- Study dates
- 11 Oct 2023to Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 63 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
- Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
- Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
- Current episode of AA of less than 8 years.
Who cannot join
- Current diagnosis of primarily diffuse type of AA.
- Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
- Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.
Trial locations and contacts
272 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
272 sites in 28 countries
United States78 sites, 30 recruiting
- Recruiting
Arlington Research Center, Inc /ID# 258028
Arlington, Texas, 76011
- Completed
Great Lakes Research Group - Bay City /ID# 259100
Bay City, Michigan, 48706
- Recruiting
Bellaire Dermatology Associates /ID# 259360
Bellaire, Texas, 77401
- Active, not recruiting
Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, Alabama, 35205
- Recruiting
Skin Care Research Boca Raton /ID# 258012
Boca Raton, Florida, 33486-2269
Site Coordinator, +1-561-948-3116
- Active, not recruiting
MetroBoston Clinical Partners /ID# 259559
Boston, Massachusetts, 02135-3511
- Active, not recruiting
Apex Clinical Trials /ID# 259205
Brandon, Florida, 33511
- Completed
Lahey Hospital and Medical Center /ID# 260484
Burlington, Massachusetts, 01805
- Recruiting
Derm Institute of West Michigan /ID# 259546
Caledonia, Michigan, 49316-7478
Site Coordinator, 616-512-4445
- Completed
Hamzavi Dermatology - Canton /ID# 260115
Canton, Michigan, 48187
- Recruiting
U.S. Dermatology Partners - Cedar Park /ID# 259367
Cedar Park, Texas, 78613
Site Coordinator, 512-260-5860
- Active, not recruiting
Medical University of South Carolina /ID# 259828
Charleston, South Carolina, 29425
- Completed
Northwestern Medicine - Northwestern Memorial Hospital /ID# 259555
Chicago, Illinois, 60611
- Recruiting
Clarkston Dermatology /ID# 258018
Clarkston, Michigan, 48346
- Recruiting
Cleveland Clinic - Cleveland /ID# 258113
Cleveland, Ohio, 44195
- Active, not recruiting
Clinical Research Institute of Michigan /ID# 259802
Clinton Township, Michigan, 48038
- Active, not recruiting
Remington-Davis Clinical Research /ID# 258106
Columbus, Ohio, 43215
- Active, not recruiting
Florida Academic Dermatology Center /ID# 259353
Coral Gables, Florida, 33134-5755
- Completed
Skin Research Institute LLC /ID# 259207
Coral Gables, Florida, 33146-1837
- Recruiting
Dermatology Treatment and Research Center /ID# 259357
Dallas, Texas, 75230
- Completed
Modern Research Associates /ID# 259349
Dallas, Texas, 75231
- Completed
Reveal Research Institute - Dallas /ID# 259361
Dallas, Texas, 75235
- Active, not recruiting
Cleaver Medical Group Dermatology /ID# 259801
Dawsonville, Georgia, 30534
- Active, not recruiting
Henry Ford Medical Center - New Center One /ID# 258067
Detroit, Michigan, 48202-3046
- Completed
Revival Research /ID# 259213
Doral, Florida, 33122-1902
- Completed
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
Encino, California, 91436
- Active, not recruiting
Johnson Dermatology Clinic /ID# 259103
Fort Smith, Arkansas, 72916-6103
- Recruiting
First Oc Dermatology /ID# 259220
Fountain Valley, California, 92708
- Completed
Duplicate_Advanced Research Associates - Glendale /ID# 259108
Glendale, Arizona, 85308
- Recruiting
Skin Care Research - Hollywood /ID# 259210
Hollywood, Florida, 33021-6748
Site Coordinator, +1-561-948-3116
- Completed
Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
Houston, Texas, 77065
- Completed
Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 258206
Huntersville, North Carolina, 28078-7961
- Recruiting
Indiana University Health University Hospital /ID# 259827
Indianapolis, Indiana, 46202
- Active, not recruiting
University of California Irvine /ID# 259096
Irvine, California, 92697-1385
- Recruiting
Las Vegas Dermatology /ID# 279317
Las Vegas, Nevada, 89144
Site Coordinator, 702 456 3120
- Completed
U.S. Dermatology Partners Leawood /ID# 259203
Leawood, Kansas, 66211-1453
- Completed
Dermatology and Skin Center of Lees Summit /ID# 259206
Lee's Summit, Missouri, 64064-2301
- Active, not recruiting
Nebraska Dermatology /ID# 259354
Lincoln, Nebraska, 68512
- Recruiting
Dermatology Research Associates /ID# 258033
Los Angeles, California, 90045
- Recruiting
GSI Clinical Research, LLC /ID# 259352
Margate, Florida, 33063
- Active, not recruiting
Life Clinical Trials - N State Rd - Margate /ID# 259358
Margate, Florida, 33063
- Active, not recruiting
Marietta Dermatology /ID# 259818
Marietta, Georgia, 30060
- Completed
Raven Clinical Research /ID# 268453
Marriottsville, Maryland, 21104
- Recruiting
Dermatologists of Southwest Ohio /ID# 260116
Mason, Ohio, 45040-4520
Site Coordinator, 513-701-5526
- Recruiting
Lenus Research and Medical Group /ID# 259356
Miami, Florida, 33172
- Active, not recruiting
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122
Minneapolis, Minnesota, 55455
- Recruiting
West Virginia University Hospitals /ID# 278707
Morgantown, West Virginia, 26506
- Recruiting
International Clinical Research - Tennessee LLC /ID# 259552
Murfreesboro, Tennessee, 37130-2450
- Completed
Minnesota Clinical Study Center /ID# 259218
New Brighton, Minnesota, 55112
- Active, not recruiting
The Skin Center Dermatology Group. /ID# 266748
New City, New York, 10956-7153
- Recruiting
Tulane University School of Medicine /ID# 259799
New Orleans, Louisiana, 70112
Site Coordinator, 504-988-5135
- Completed
Schweiger Dermatology, P.C. /ID# 258007
New York, New York, 07044-2946
- Completed
Schweiger Dermatology, P.C. /ID# 259531
New York, New York, 07044-2946
- Recruiting
Equity Medical /ID# 266680
New York, New York, 10023-7340
- Active, not recruiting
Icahn School of Medicine at Mount Sinai /ID# 259808
New York, New York, 10029
- Recruiting
Sadick Research Group LLC /ID# 266790
New York, New York, 10075
- Recruiting
Skin Specialists /ID# 259237
Omaha, Nebraska, 68144
Site Coordinator, 402-697-6599
- Completed
Southwest Skin Specialists /ID# 258234
Phoenix, Arizona, 85018-3953
- Active, not recruiting
Alliance Dermatology and Mohs Center /ID# 258111
Phoenix, Arizona, 85032
- Active, not recruiting
University of Pittsburgh Medical Center /ID# 266681
Pittsburgh, Pennsylvania, 15213
- Recruiting
Oregon Dermatology and Research Center /ID# 258243
Portland, Oregon, 97210
- Active, not recruiting
Oregon Medical Research Center /ID# 258107
Portland, Oregon, 97223
- Active, not recruiting
Health Concepts /ID# 266678
Rapid City, South Dakota, 57702
- Completed
Stanford University School of Medicine - Redwood City /ID# 259542
Redwood City, California, 94063
- Recruiting
Skin Cancer and Dermatology Institute - Reno /ID# 259208
Reno, Nevada, 89509
Site Coordinator, 775-336-3665
- Recruiting
Integrative Skin Science and Research /ID# 258114
Sacramento, California, 95815
- Recruiting
University of California Davis Health /ID# 258112
Sacramento, California, 95817
Site Coordinator, 916-551-2635
- Active, not recruiting
Progressive Clinical Research /ID# 259365
San Antonio, Texas, 78229
- Completed
International Clinical Research - Sanford /ID# 259547
Sanford, Florida, 32771
- Active, not recruiting
NorthShore University HealthSystem - Skokie /ID# 266684
Skokie, Illinois, 60077
- Recruiting
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359
Spartanburg, South Carolina, 29307
Site Coordinator, 864 574-0017 ext 8
- Recruiting
Dermatology Specialists of Spokane /ID# 278362
Spokane, Washington, 99202
- Completed
Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746
Springfield, Ohio, 45505
- Active, not recruiting
Complete Dermatology /ID# 258025
Sugar Land, Texas, 77479-3794
- Completed
FWD Clinical Research /ID# 266687
Tamarac, Florida, 33321-2931
- Recruiting
Advanced Clinical Research Institute - Tampa /ID# 259204
Tampa, Florida, 33607
Site Coordinator, 1-813-362-1037
- Completed
Avita Clinical Research /ID# 258011
Tampa, Florida, 33613-1825
- Recruiting
Clinical Trials Research Institute /ID# 258021
Thousand Oaks, California, 91320-2130
China25 sites, 5 recruiting
- Recruiting
Beijing Chaoyang Hospital,Capital Medical University /ID# 258912
Beijing, Beijing Municipality, 100020
Site Coordinator, +86 010-85231777
- Active, not recruiting
China-Japan Friendship Hospital /ID# 258941
Beijing, Beijing Municipality, 100029
- Recruiting
Peking University People's Hospital /ID# 258940
Beijing, Beijing Municipality, 100044
Site Coordinator, +86 010-88326666
- Active, not recruiting
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 266715
Beijing, Beijing Municipality, 100730
- Recruiting
The First Hospital of Jilin University /ID# 257496
Changchun, Jilin, 130021
- Active, not recruiting
Chengdu Second Municipal People's Hospital /ID# 259492
Chengdu, Sichuan, 610017
- Completed
West China Hospital, Sichuan University /ID# 259560
Chengdu, Sichuan, 610041
- Active, not recruiting
The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
Chongqing, Chongqing Municipality, 400010
- Active, not recruiting
The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
Guangzhou, Guangdong, 510080
- Active, not recruiting
Dermatology Hospital of Southern Medical University /ID# 257118
Guangzhou, Guangdong, 510091
- Active, not recruiting
The First Affiliated Hospital Of Guangzhou Medical University /ID# 258663
Guangzhou, Guangdong, 510163
- Active, not recruiting
Zhujiang Hospital of Southern Medical University /ID# 258485
Guangzhou, Guangdong, 510280
- Active, not recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 257260
Hangzhou, Zhejiang, 310009
- Active, not recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119
Hangzhou, Zhejiang, 310020
- Recruiting
Affiliated Dermatology Hospital of Shandong First Medical University /ID# 267520
Jinan, Shandong, 250022
Site Coordinator, +86 0531-87298808
- Active, not recruiting
Dermatology Hospital of Jiangxi Provincial /ID# 259488
Nanchang, Jiangxi, 330030
- Active, not recruiting
Huashan Hospital, Fudan University /ID# 257758
Shanghai, Shanghai Municipality, 200040
- Active, not recruiting
Shenzhen People's Hospital /ID# 258208
Shenzhen, Guangdong, 518020
- Active, not recruiting
Shenzhen Second Peoples Hospital /ID# 258060
Shenzhen, Guangdong, 518039
- Active, not recruiting
First Affiliated Hospital of Shanxi Medical University /ID# 259647
Taiyuan, Shanxi, 030001
- Active, not recruiting
Tianjin Medical University General Hospital /ID# 259525
Tianjin, Tianjin Municipality, 300052
- Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
Wenzhou, Zhejiang, 325000
- Recruiting
Union Hospital - Tongji Medical College /ID# 266737
Wuhan, Hubei, 430022
Site Coordinator, +86 027-85726114
- Active, not recruiting
Renmin Hospital of Wuhan University /ID# 260260
Wuhan, Hubei, 430060
- Active, not recruiting
Second Affiliated Hospital of Xian Jiaotong University /ID# 257497
Xi'an, Shaanxi, 710004
Canada16 sites
- Active, not recruiting
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
Barrie, Ontario, L4M 7G1
- Active, not recruiting
Dermatology Research Institute - Blackfoot Trail /ID# 258818
Calgary, Alberta, T2J 7E1
- Active, not recruiting
Beacon Dermatology /ID# 258817
Calgary, Alberta, T3A 2N1
- Active, not recruiting
Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
Edmonton, Alberta, T5J 3S9
- Active, not recruiting
Medicor Research Inc /ID# 258810
Greater Sudbury, Ontario, P3C 1X3
- Active, not recruiting
Leader Research /ID# 267028
Hamilton, Ontario, L8L 3C3
- Active, not recruiting
Lynderm Research Inc /ID# 258815
Markham, Ontario, L3P 1X2
- Active, not recruiting
Innovaderm Research Inc. /ID# 258812
Montreal, Quebec, H2X 2V1
- Active, not recruiting
JRB Research /ID# 259248
Ottawa, Ontario, K1H 7X3
- Active, not recruiting
SKiN Centre for Dermatology /ID# 258813
Peterborough, Ontario, K9J 5K2
- Active, not recruiting
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
Québec, Quebec, G2G 2R1
- Active, not recruiting
York Dermatology Clinic and Research Centre /ID# 267026
Richmond Hill, Ontario, L4C 9M7
- Active, not recruiting
Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
Saint-Jérôme, Quebec, J7Z 7E2
- Active, not recruiting
Dr. Chih-ho Hong Medical Inc. /ID# 258814
Surrey, British Columbia, V3R 6A7
- Active, not recruiting
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
Waterloo, Ontario, N2J 1C4
- Active, not recruiting
Wiseman Dermatology Research /ID# 258819
Winnipeg, Manitoba, R3M 3Z4
Italy12 sites
- Active, not recruiting
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 257499
Bologna, 40138
- Active, not recruiting
ASST degli Spedali Civili di Brescia /ID# 257508
Brescia, 25123
- Active, not recruiting
AOU Policlinico G. Rodolico - San Marco /ID# 257507
Catania, 95123
- Completed
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 257501
Florence, Firenze, 50122
- Active, not recruiting
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 257506
L’Aquila, L Aquila, 67100
- Active, not recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 257503
Milan, 20122
- Active, not recruiting
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 257504
Naples, Napoli, 80131
- Active, not recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Miraglia /ID# 258585
Naples, Napoli, 80138
- Completed
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 257502
Rome, Roma, 00133
- Active, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 257513
Rome, Roma, 00161
- Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 257505
Rome, Roma, 00168
- Active, not recruiting
IRCCS Istituto Clinico Humanitas /ID# 257500
Rozzano, Lombardy, 20089
South Korea11 sites
- Active, not recruiting
Pusan National University Hospital /ID# 257910
Busan, Busan Gwang Yeogsi, 49241
- Active, not recruiting
Kyungpook National University Hospital /ID# 257908
Daegu, Daegu Gwang Yeogsi, 41944
- Active, not recruiting
Chungnam National University Hospital /ID# 267151
Daejeon, Daejeon Gwang Yeogsi, 35015
- Active, not recruiting
Inha University Hospital /ID# 257904
Incheon, Incheon Gwang Yeogsi, 21565
- Active, not recruiting
Jeonbuk National University Hospital /ID# 267154
Jeonju, Jeonrabugdo, 54907
- Active, not recruiting
Seoul National University Bundang Hospital /ID# 257906
Seongnam-si, Gyeonggido, 13620
- Active, not recruiting
Seoul National University Hospital /ID# 257903
Seoul, Seoul Teugbyeolsi, 03080
- Active, not recruiting
Konkuk University Medical Center /ID# 257900
Seoul, Seoul Teugbyeolsi, 05030
- Active, not recruiting
Kyung Hee University Hospital at Gangdong /ID# 257907
Seoul, Seoul Teugbyeolsi, 05278
- Completed
Chungang University Hospital /ID# 267155
Seoul, Seoul Teugbyeolsi, 06973
- Active, not recruiting
Hallym University Kangdong Sacred Heart Hospital /ID# 257905
Seoul, 05355
France10 sites
- Completed
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 257519
Bordeaux, Gironde, 33000
- Active, not recruiting
CHRU de Brest - Hopital Morvan /ID# 256979
Brest, 29200
- Active, not recruiting
HCL - Hopital Edouard Herriot /ID# 256983
Lyon, Rhone, 69003
- Active, not recruiting
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256982
Nantes, Pays de la Loire Region, 44000
- Active, not recruiting
Chu de Nice-Hopital Larchet Ii /Id# 256978
Nice, Alpes-Maritimes, 06202
- Active, not recruiting
Centre de Sante Sabouraud /ID# 257213
Paris, 75010
- Active, not recruiting
Polyclinique Courlancy /ID# 256977
Reims, Marne, 51100
- Completed
Hopital Ponchaillou /ID# 257520
Rennes, Brittany Region, 35000
- Active, not recruiting
Hôpital Charles-Nicolle /ID# 256981
Rouen, 76000
- Active, not recruiting
CHU Toulouse - Hopital Larrey /ID# 256980
Toulouse, Haute-Garonne, 31400
Poland10 sites
- Active, not recruiting
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 257531
Bialystok, Podlaskie Voivodeship, 15-351
- Active, not recruiting
Centrum Medyczne ALL-MED Badania Kliniczne /ID# 257590
Cracow, 30-033
- Active, not recruiting
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537
Elblag, Warmian-Masurian Voivodeship, 82-300
- Active, not recruiting
Centrum Medyczne Angelius Provita /ID# 257916
Katowice, Silesian Voivodeship, 40-615
- Active, not recruiting
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 257534
Krakow, Lesser Poland Voivodeship, 30-002
- Completed
Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski /ID# 258242
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031
- Active, not recruiting
Medicover Integrated Clinical Services - Torun (SMO/Network/Consortium) /ID# 257740
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Active, not recruiting
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 257598
Warsaw, Masovian Voivodeship, 00-716
- Active, not recruiting
Royalderm Agnieszka Nawrocka /ID# 257536
Warsaw, Masovian Voivodeship, 02-962
- Active, not recruiting
Penta Hospitals Badania Kliniczne /ID# 257535
Wroclaw, Lower Silesian Voivodeship, 54-429
Australia8 sites
- Active, not recruiting
Skin Health Institute Inc /ID# 258570
Carlton, Victoria, 3053
- Active, not recruiting
Cornerstone Dermatology /ID# 258769
Coorparoo, Queensland, 4151
- Active, not recruiting
Momentum Clinical Research /ID# 258571
Darlinghurst, New South Wales, 2010
- Active, not recruiting
Sinclair Dermatology - Melbourne /ID# 258565
East Melbourne, Victoria, 3002
- Active, not recruiting
Fremantle Dermatology /ID# 260207
Fremantle, Western Australia, 6160
- Active, not recruiting
St George Dermatology & Skin Cancer Centre /ID# 258567
Kogarah, New South Wales, 2217
- Active, not recruiting
The Royal Melbourne Hospital /ID# 258770
Parkville, Victoria, 3050
- Active, not recruiting
Veracity Clinical Research /ID# 258566
Woolloongabba, Queensland, 4102
Japan8 sites
- Active, not recruiting
Hamamatsu University Hospital /ID# 257253
Hamamatsu, Shizuoka, 431-3192
- Active, not recruiting
Kurume University Hospital /ID# 257255
Kurume-shi, Fukuoka, 830-0011
- Active, not recruiting
Kyorin University Hospital /ID# 257283
Mitaka-shi, Tokyo, 181-8611
- Active, not recruiting
Niigata University Medical and Dental Hospital /ID# 259425
Niigata, Niigata, 951-8520
- Active, not recruiting
Osaka Metropolitan University Hospital /ID# 257256
Osaka, Osaka, 545-8586
- Active, not recruiting
Kitasato University Hospital /ID# 257285
Sagamihara-shi, Kanagawa, 252-0375
- Active, not recruiting
Tokyo Medical University Hospital /ID# 258132
Shinjuku-ku, Tokyo, 160-0023
- Active, not recruiting
Yamaguchi University Hospital /ID# 257252
Ube-shi, Yamaguchi, 755-8505
United Kingdom7 sites
- Active, not recruiting
Royal Sussex County Hospital /ID# 257912
Brighton, East Sussex, BN2 5BE
- Active, not recruiting
Gloucestershire Royal Hospital /ID# 257953
Gloucester, Gloucestershire, GL1 3NN
- Active, not recruiting
London North West University Healthcare NHS Trust /ID# 257914
Harrow, HA1 3UJ
- Active, not recruiting
Velocity Clinical Research Ltd /ID# 257925
High Wycombe, Buckinghamshire, HP11 2QW
- Active, not recruiting
Chelsea and Westminster Hospital /ID# 259128
London, Greater London, SW10 9NH
- Active, not recruiting
Oxford University Hospitals NHS Foundation Trust /ID# 257948
Oxford, Oxfordshire, OX3 9DU
- Active, not recruiting
Northern Care Alliance NHS Group /ID# 257952
Salford, M6 8HD
Belgium6 sites, 4 recruiting
- Recruiting
Universite Libre de Bruxelles - Hopital Erasme /ID# 257314
Anderlecht, Brussels Capital, 1070
- Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 257320
Brussels, Brussels Capital, 1200
- Recruiting
UZ Gent /ID# 257317
Ghent, Oost-Vlaanderen, 9000
- Recruiting
Universitair Ziekenhuis Brussel /ID# 257325
Jette, Brussels Capital, 1090
- Completed
CHU de Liege /ID# 257316
Liège, 4000
- Active, not recruiting
AZ Delta - campus Torhout /ID# 257321
Torhout, West-Vlaanderen, 8820
Bulgaria6 sites
- Active, not recruiting
UMHAT Sveti Georgi /ID# 257548
Plovdiv, 4002
- Completed
Duplicate_Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseas /ID# 257047
Sofia, 1407
- Active, not recruiting
Diagnostic Consultative Center Aleksandrovska /ID# 257049
Sofiya, Sofia, 1431
- Active, not recruiting
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 257048
Sofiya, Sofia, 1463
- Active, not recruiting
Diagnosis - Consult Centre 20 - Sofia /ID# 257273
Sofiya, Sofia, 1618
- Active, not recruiting
UMHAT Professor Stoyan Kirkovich /ID# 257051
Stara Zagora, 6000
Germany6 sites, 4 recruiting
- Recruiting
Fachklinik Bad Bentheim /ID# 257741
Bad Bentheim, Lower Saxony, 48455
- Recruiting
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310
Berlin, 10117
Site Coordinator, +4930450518176
- Active, not recruiting
Universitaetsklinikum Duesseldorf /ID# 257307
Düsseldorf, North Rhine-Westphalia, 40225
- Active, not recruiting
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 257305
Lübeck, Schleswig-Holstein, 23538
- Recruiting
TUM Klinikum rechts der Isar /ID# 257609
Munich, Bavaria, 81675
- Recruiting
Universitaetsklinikum Muenster - Von-Esmarch-Strasse /ID# 257306
Münster, North Rhine-Westphalia, 48149
Site Coordinator, +49 251 8356558
Hungary6 sites, 2 recruiting
- Recruiting
Debreceni Egyetem-Klinikai Kozpont /ID# 257465
Debrecen, Hajdú-Bihar, 4032
- Completed
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 257469
Debrecen, 4031
- Active, not recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 257472
Kecskemét, Bács-Kiskun county, 6000
- Completed
Bagoly Egeszseghaz (Meditres Kft.) /ID# 258032
Kecskemét, Bács-Kiskun county, 6000
- Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 257468
Pécs, Baranya, 7624
- Active, not recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 258552
Szeged, Csongrád megye, 6725
Spain6 sites, 1 recruiting
- Active, not recruiting
Hospital Santa Creu i Sant Pau /ID# 257034
Barcelona, 08041
- Completed
Hospital Universitario Reina Sofia /ID# 257035
Córdoba, 14004
- Active, not recruiting
Hospital Universitario de Fuenlabrada /ID# 257334
Fuenlabrada, Madrid, 28942
- Active, not recruiting
Hospital Universitari de Bellvitge /ID# 257332
L'Hospitalet de Llobregat, Barcelona, 08907
- Active, not recruiting
Hospital Universitario La Paz /ID# 257333
Madrid, 28046
- Recruiting
Hospital Universitario Dr. Peset /ID# 257036
Valencia, 46017
Argentina5 sites
- Active, not recruiting
Ciprec (Centro De Investigacion Y Prevencion Cardiovascular) - Barrio Norte /ID# 258639
Buenos Aires, 1061
- Active, not recruiting
Buenos Aires Skin /ID# 258297
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055
- Active, not recruiting
Instituto de Neumonologia y Dermatologia /ID# 258640
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425
- Active, not recruiting
Psoriahue Med Interdisciplinar /ID# 258641
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425
- Active, not recruiting
Instituto De Investigaciones Clinicas Cordoba /ID# 260244
Córdoba, 5000
Brazil5 sites
- Active, not recruiting
Upeclin Fmb - Unesp /Id# 258046
Botucatu, São Paulo, 18618-686
- Active, not recruiting
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 258105
Campinas, São Paulo, 13034-685
- Active, not recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
Porto Alegre, Rio Grande do Sul, 90020-090
- Active, not recruiting
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
Rio de Janeiro, 20241-180
- Active, not recruiting
Hospital Alemao Oswaldo Cruz /ID# 258104
São Paulo, 01323-020
Croatia5 sites
- Active, not recruiting
Specialty Hospital Medico /ID# 257629
Rijeka, Primorje-Gorski Kotar County, 51000
- Active, not recruiting
Klinicki Bolnicki Centar Split /ID# 257632
Split, Split-Dalmatia County, 21000
- Active, not recruiting
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 257151
Zagreb, City of Zagreb, 10000
- Active, not recruiting
Klinicki bolnicki centar Zagreb /ID# 257630
Zagreb, City of Zagreb, 10000
- Active, not recruiting
Poliklinika Solmed /ID# 257651
Zagreb, City of Zagreb, 10000
Israel5 sites
- Active, not recruiting
Rambam Health Care Campus- Haifa /ID# 257769
Haifa, 3109601
- Active, not recruiting
Hadassah Medical Center-Hebrew University /ID# 257946
Jerusalem, Jerusalem, 91120
- Completed
Rabin Medical Center. /ID# 257772
Petah Tikva, Central District, 4941492
- Active, not recruiting
The Chaim Sheba Medical Center /ID# 257770
Ramat Gan, Tel Aviv, 5265601
- Completed
Tel Aviv Sourasky Medical Center /ID# 257771
Tel Aviv, Tel Aviv, 6423906
Puerto Rico5 sites
- Completed
Santa Cruz Behavioral (SCB) Research Center /ID# 259350
Bayamón, 00961-6910
- Active, not recruiting
Dr. Samuel Sanchez PSC /ID# 259359
Caguas, 00727
- Active, not recruiting
Clinical Research Puerto Rico /ID# 259355
San Juan, 00909-1711
- Active, not recruiting
GCM Medical Group /ID# 258013
San Juan, 00917-3104
- Completed
Mindful Medical Research /ID# 260113
San Juan, 00918-3756
Taiwan5 sites
- Active, not recruiting
Kaohsiung Chang Gung Memorial Hospital /ID# 258726
Kaohsiung City, 833
- Active, not recruiting
National Cheng Kung University Hospital /ID# 257409
Tainan, 704
- Active, not recruiting
National Taiwan University Hospital /ID# 257407
Taipei, 100
- Active, not recruiting
Taipei Veterans General Hosp /ID# 257413
Taipei, 11217
- Active, not recruiting
Linkou Chang Gung Memorial Hospital /ID# 258725
Taoyuan City, 333
Turkey (Türkiye)5 sites
- Active, not recruiting
Gulhane Egitim ve Arastirma Hastanesi /ID# 257509
Ankara, Antalya, 06010
- Active, not recruiting
Ankara City Hospital /ID# 257417
Ankara, 06800
- Active, not recruiting
Gaziantep Universitesi /ID# 257418
Gaziantep, 27310
- Active, not recruiting
Bagcilar Medipol Mega Universite Hastanesi /ID# 257449
Istanbul, 34214
- Active, not recruiting
Erciyes University Medical Faculty /ID# 259034
Kayseri, 38039
Chile4 sites
- Active, not recruiting
Fundacion Innovacion Cardiovascular /ID# 259313
Independencia, Santiago Metropolitan, 8380465
- Active, not recruiting
Centro Medico Skin Med SPA /ID# 259314
Las Condes, Region Metropolitana Santiago, 7580206
- Active, not recruiting
Centro Internacional de Estudios Clinicos - CIEC /ID# 259312
Santiago, Region Metropolitana Santiago, 8420383
- Active, not recruiting
Clinica Dermacross /ID# 259311
Vitacura, Region Metropolitana Santiago, 7640881
Greece4 sites
- Active, not recruiting
General Hospital Andreas Syggros /ID# 257259
Athens, Attica, 16121
- Active, not recruiting
General Hospital Andreas Syggros /ID# 257262
Athens, Attica, 16121
- Active, not recruiting
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 257263
Thessaloniki, 54643
- Active, not recruiting
Papageorgiou General Hospital /ID# 257258
Thessaloniki, 56429
New Zealand4 sites
- Active, not recruiting
Aotearoa Clinical Trials. /ID# 258562
Auckland, 2025
- Active, not recruiting
Greenlane Clinical Centre /ID# 258563
Epsom, Auckland, 1051
- Active, not recruiting
Clinical Trials New Zealand /ID# 258564
Hamilton, Waikato Region, 3204
- Active, not recruiting
P3 Research Ltd /ID# 259846
Wellington, 6021
Slovakia4 sites
- Active, not recruiting
Univerzitna nemocnica Bratislava, Nemocnica Stare mesto /ID# 257594
Bratislava, Bratislava Region, 811 07
- Active, not recruiting
Derma therapy /ID# 257595
Bratislava, Bratislava Region, 851 01
- Active, not recruiting
Fakultna Nemocnica J.A. Reimana /ID# 257593
Prešov, Presov, 080 01
- Active, not recruiting
Kaderma Majtan s.r.o. /ID# 257596
Topoľčany, 955 01
Portugal3 sites
- Active, not recruiting
Unidade Local de Saude de Almada-Seixal, EPE /ID# 257425
Almada, Setúbal District, 2805-267
- Active, not recruiting
Hospital CUF Descobertas /ID# 257419
Lisbon, 1998-018
- Active, not recruiting
Unidade Local de Saude de Santo Antonio /ID# 258554
Porto, 4099-003
Sweden3 sites
- Active, not recruiting
CTC GoCo /ID# 257714
Mölndal, Västra Götaland County, 431 53
- Active, not recruiting
Karolinska University Hospital Solna /ID# 257094
Solna, Stockholm County, 171 64
- Active, not recruiting
Diagnostiskt Centrum Hud /ID# 257229
Stockholm, Stockholm County, 111 37
About this study
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.
Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.
Read more
Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.
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.
- Conditions
- Alopecia Areata
- Being tested
- Upadacitinib, Placebo
- Keywords
- Alopecia Areata, Upadacitinib, Rinvoq, ABT-494
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called Rinvoq, ABT-494
Oral Tablets
PlaceboDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Group 1 Upadacitinib Dose A | Experimental | Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 1: Group 2 Upadacitinib Dose B | Experimental | Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 1: Group 3 Placebo | Experimental | Participants will receive matching placebo once daily for 24 weeks in Period A. Receives: Drug: Placebo |
| Study 1: Group 4 Upadacitinib Dose A | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib; Drug: Placebo |
| Study 1: Group 5 Upadacitinib Dose B | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib; Drug: Placebo |
| Study 1: Group 6 Placebo | Experimental | Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160. Receives: Drug: Placebo |
| Study 2: Group 1 Upadacitinib Dose A | Experimental | Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 2: Group 2 Upadacitinib Dose B | Experimental | Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 2: Group 3 Placebo | Experimental | Participants will receive matching placebo once daily for 24 weeks in Period A. Receives: Drug: Placebo |
| Study 2: Group 4 Upadacitinib Dose A | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib; Drug: Placebo |
| Study 2: Group 5 Upadacitinib Dose B | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib; Drug: Placebo |
| Study 2: Group 6 Placebo | Experimental | Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160. Receives: Drug: Placebo |
| Study 3: Group 1 Upadacitinib Dose B (SALT > 20) | Experimental | Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks. Receives: Drug: Upadacitinib |
| Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20) | Experimental | Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks. Receives: Drug: Upadacitinib |
| Study 3: Group 3 Upadacitinib Dose B (Non-Sustained) | Experimental | Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks. Receives: Drug: Upadacitinib |
| Study 3: Group 4 Upadacitinib Dose B (Sustained) | Experimental | Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks. Receives: Drug: Upadacitinib |
| Study 3: Group 5 Upadacitinib Dose A (Sustained) | Experimental | Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks. Receives: Drug: Upadacitinib |
| Study 4: Group 1 Upadacitinib Dose A | Experimental | US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 4: Group 2 Upadacitinib Dose B | Experimental | US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Study 4: Group 3 Placebo | Experimental | US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A. Receives: Drug: Placebo |
| Study 4: Group 4 Upadacitinib Dose A | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib |
| Study 4: Group 5 Upadacitinib Dose B | Experimental | Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib |
| Study 4: Group 6 Placebo | Experimental | Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Week 24
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 164 weeks
Secondary outcomes (16)
Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Week 24
Percentage of Participants with the Achievement of SALT Score <= 10
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Up to Week 24
Percentage of Participants with the Achievement of SALT Score <= 20
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Up to Week 12
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
Measured: Baseline to Week 24
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
The ClinRO for Eyelash Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
Measured: Baseline to Week 24
Percentage of Participants with the Achievement of SALT 75
SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
Measured: Baseline to Week 24
Percentage of Participants with the Achievement of SALT 90
SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
Measured: Baseline to Week 24
Percent Change from Baseline in SALT Score
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Baseline to Week 24
Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"
The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
Measured: Up to Week 24
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score >=3.
Measured: Baseline to Week 24
Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
The AASIS Interference Subscale is a 6-item assessment with scores ranging from 0 = 'did not interfere' to 10 = 'interfered completely' with higher scores indicating greater symptom interference.
Measured: Week 24
Change from Baseline in AASIS Symptoms Subscale Score
The AASIS Symptom Subscale is a 7-item assessment with scores ranging from 0 = 'not present' to 10 = 'as bad as you can imagine' with higher scores indicating greater symptom severity.
Measured: Week 24
Change from Baseline in Skindex-16 AA Emotions Domain Scores
The Skindex-16 AA Emotions Domain is a 7-item assessment ranging from 0 = never bothered to 6 = always bothered that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
Measured: Week 24
Change from Baseline in Skindex-16 AA Functioning Domain Scores
The Skindex-16 AA Emotions Domain is a 5-item assessment ranging from 0 = never bothered to 6 = always bothered, that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
Measured: Week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-Anxiety < 8 and HADS-Depression < 8 at Week 24 Among Participants with HADS-A >= 8 or HADS-D >= 8 at Baseline
The HADS is a self-administered scale which measures anxiety and depression. It contains 14 items and is comprised of anxiety (7 items) and depression (7 items) subscales, which are scored separately and summed to give a total score. Item scores range from 0 (best) to 3 (worst), and total scores are categorized as normal (0 to 7), borderline abnormal (8 to 10), and abnormal (11 to 21).
Measured: Baseline to Week 24
Percentage of Participants with the Achievement of SALT Score 0
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Oct 2023
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012240
- Sponsor's protocol ID
- M23-716
- Other IDs
- 2023-505061-82-01, 2023
- Acronym
- Up-AA
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Publications
Mostaghimi A, Gooderham MJ, Lynde C, Sinclair R, King B, Hordinsky M, Rudnicka L, Guttman-Yassky E, Serrao R, Ohyama M, Zhang X, Magnolo N, Kwon O, Oddi C, Meerwein S, Soliman AM, Bu X, Duan C, Wu T, Teixeira HD, Lazar A, Passeron T. Upadacitinib for Severe Alopecia Areata in Adults and Adolescents: Two Phase 3 UP-AA Randomized Clinical Trials. JAMA Dermatol. 2026 Aug 12:e262853. doi: 10.1001/jamadermatol.2026.2853. Online ahead of print.
PubMed 42584887