A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Up-AA
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
2 other identifiers
interventional
1,500
28 countries
268
Brief 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. 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Longer than P75 for phase_3
268 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedStudy Start
First participant enrolled
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
April 17, 2026
April 1, 2026
6.5 years
August 22, 2023
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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%.
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.
Up to approximately 164 weeks
Secondary Outcomes (16)
Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
Week 24
Percentage of Participants with the Achievement of SALT Score <= 10
Up to Week 24
Percentage of Participants with the Achievement of SALT Score <= 20
Up to Week 12
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Baseline to Week 24
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
Baseline to Week 24
- +11 more secondary outcomes
Study Arms (23)
Study 1: Group 1 Upadacitinib Dose A
EXPERIMENTALParticipants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Study 1: Group 2 Upadacitinib Dose B
EXPERIMENTALParticipants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Study 1: Group 3 Placebo
EXPERIMENTALParticipants will receive matching placebo once daily for 24 weeks in Period A.
Study 1: Group 4 Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Study 1: Group 5 Upadacitinib Dose B
EXPERIMENTALParticipants 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.
Study 1: Group 6 Placebo
EXPERIMENTALParticipants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Study 2: Group 1 Upadacitinib Dose A
EXPERIMENTALParticipants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Study 2: Group 2 Upadacitinib Dose B
EXPERIMENTALParticipants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Study 2: Group 3 Placebo
EXPERIMENTALParticipants will receive matching placebo once daily for 24 weeks in Period A.
Study 2: Group 4 Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Study 2: Group 5 Upadacitinib Dose B
EXPERIMENTALParticipants 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.
Study 2: Group 6 Placebo
EXPERIMENTALParticipants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
EXPERIMENTALParticipants 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.
Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
EXPERIMENTALParticipants 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.
Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
EXPERIMENTALParticipants 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.
Study 3: Group 4 Upadacitinib Dose B (Sustained)
EXPERIMENTALParticipants 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.
Study 3: Group 5 Upadacitinib Dose A (Sustained)
EXPERIMENTALParticipants 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.
Study 4: Group 1 Upadacitinib Dose A
EXPERIMENTALUS only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Study 4: Group 2 Upadacitinib Dose B
EXPERIMENTALUS only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Study 4: Group 3 Placebo
EXPERIMENTALUS only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.
Study 4: Group 4 Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Study 4: Group 5 Upadacitinib Dose B
EXPERIMENTALParticipants 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.
Study 4: Group 6 Placebo
EXPERIMENTALParticipants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Interventions
Oral Tablets
Oral Tablets
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (268)
Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, Alabama, 35205, United States
Duplicate_Advanced Research Associates - Glendale /ID# 259108
Glendale, Arizona, 85308, United States
Southwest Skin Specialists /ID# 258234
Phoenix, Arizona, 85018-3953, United States
Alliance Dermatology and Mohs Center /ID# 258111
Phoenix, Arizona, 85032, United States
Johnson Dermatology Clinic /ID# 259103
Fort Smith, Arkansas, 72916-6103, United States
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
Encino, California, 91436, United States
First OC Dermatology /ID# 259220
Fountain Valley, California, 92708, United States
University of California Irvine /ID# 259096
Irvine, California, 92697-1385, United States
Dermatology Research Associates /ID# 258033
Los Angeles, California, 90045, United States
Stanford University School of Medicine - Redwood City /ID# 259542
Redwood City, California, 94063, United States
Integrative Skin Science and Research /ID# 258114
Sacramento, California, 95815, United States
University of California Davis Health /ID# 258112
Sacramento, California, 95817, United States
Clinical Trials Research Institute /ID# 258021
Thousand Oaks, California, 91320-2130, United States
Skin Care Research Boca Raton /ID# 258012
Boca Raton, Florida, 33486-2269, United States
Apex Clinical Trials /ID# 259205
Brandon, Florida, 33511, United States
Florida Academic Dermatology Center /ID# 259353
Coral Gables, Florida, 33134-5755, United States
Skin Research Institute LLC /ID# 259207
Coral Gables, Florida, 33146-1837, United States
Revival Research /ID# 259213
Doral, Florida, 33122-1902, United States
Skin Care Research - Hollywood /ID# 259210
Hollywood, Florida, 33021-6748, United States
GSI Clinical Research, LLC /ID# 259352
Margate, Florida, 33063, United States
Life Clinical Trials /ID# 259358
Margate, Florida, 33063, United States
Lenus Research and Medical Group /ID# 259356
Miami, Florida, 33172, United States
International Clinical Research - Sanford /ID# 259547
Sanford, Florida, 32771, United States
FWD Clinical Research /ID# 266687
Tamarac, Florida, 33321-2931, United States
Advanced Clinical Research Institute /ID# 259204
Tampa, Florida, 33607, United States
Avita Clinical Research /ID# 258011
Tampa, Florida, 33613-1825, United States
Cleaver Medical Group Dermatology /ID# 259801
Dawsonville, Georgia, 30534, United States
Marietta Dermatology /ID# 259818
Marietta, Georgia, 30060, United States
Northwestern University Feinberg School of Medicine /ID# 259555
Chicago, Illinois, 60611-2927, United States
NorthShore University HealthSystem - Skokie /ID# 266684
Skokie, Illinois, 60077, United States
Indiana University Health University Hospital /ID# 259827
Indianapolis, Indiana, 46202, United States
U.S. Dermatology Partners Leawood /ID# 259203
Leawood, Kansas, 66211-1453, United States
Tulane University School of Medicine /ID# 259799
New Orleans, Louisiana, 70112, United States
Raven Clinical Research /ID# 268453
Marriottsville, Maryland, 21104, United States
MetroBoston Clinical Partners /ID# 259559
Boston, Massachusetts, 02135-3511, United States
Lahey Hospital & Medical Center /ID# 260484
Burlington, Massachusetts, 01805, United States
Great Lakes Research Group - Bay City /ID# 259100
Bay City, Michigan, 48706, United States
Hamzavi Dermatology - Canton /ID# 260115
Canton, Michigan, 48187, United States
Clin Res Inst of Michigan, LLC /ID# 259802
Chesterfield, Michigan, 48047, United States
Clarkston Dermatology /ID# 258018
Clarkston, Michigan, 48346, United States
Henry Ford Medical Center - New Center One /ID# 258067
Detroit, Michigan, 48202-3046, United States
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122
Minneapolis, Minnesota, 55455, United States
Minnesota Clinical Study Center /ID# 259218
New Brighton, Minnesota, 55112, United States
Dermatology and Skin Center of Lees Summit /ID# 259206
Lee's Summit, Missouri, 64064-2301, United States
Physician Research Collaboration, LLC /ID# 259354
Lincoln, Nebraska, 68516, United States
Skin Specialists /ID# 259237
Omaha, Nebraska, 68144, United States
Skin Cancer and Dermatology Institute - Reno /ID# 259208
Reno, Nevada, 89509, United States
The Skin Center Dermatology Group /ID# 266748
New City, New York, 10956-7153, United States
Schweiger Dermatology, P.C. /ID# 258007
New York, New York, 07044-2946, United States
Schweiger Dermatology, P.C. /ID# 259531
New York, New York, 07044-2946, United States
Equity Medical, LLC /ID# 266680
New York, New York, 10023-7340, United States
Icahn School of Medicine at Mount Sinai /ID# 259808
New York, New York, 10029, United States
Sadick Research Group LLC /ID# 266790
New York, New York, 10075, United States
Piedmont Plastic Surgery and Dermatology /ID# 258206
Huntersville, North Carolina, 28078-7961, United States
Cleveland Clinic - Cleveland /ID# 258113
Cleveland, Ohio, 44195, United States
Remington-Davis Clinical Research /ID# 258106
Columbus, Ohio, 43215, United States
Dermatologists of Southwest Ohio, Inc /ID# 260116
Mason, Ohio, 45040-4520, United States
Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746
Springfield, Ohio, 45505, United States
Oregon Dermatology and Research Center /ID# 258243
Portland, Oregon, 97210, United States
Oregon Medical Research Center /ID# 258107
Portland, Oregon, 97223, United States
University of Pittsburgh Medical Center /ID# 266681
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina /ID# 259828
Charleston, South Carolina, 29425, United States
ADCS - Spartanburg /ID# 278359
Spartanburg, South Carolina, 29307, United States
Health Concepts /ID# 266678
Rapid City, South Dakota, 57702, United States
International Clinical Research - Tennessee LLC /ID# 259552
Murfreesboro, Tennessee, 37130-2450, United States
Arlington Research Center, Inc /ID# 258028
Arlington, Texas, 76011, United States
Bellaire Dermatology Associates /ID# 259360
Bellaire, Texas, 77401, United States
U.S. Dermatology Partners - Cedar Park /ID# 259367
Cedar Park, Texas, 78613, United States
Dermatology Treatment and Research Center /ID# 259357
Dallas, Texas, 75230, United States
Modern Research Associates, PLLC /ID# 259349
Dallas, Texas, 75231, United States
Reveal Research Institute - Dallas /ID# 259361
Dallas, Texas, 75235, United States
Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
Houston, Texas, 77065, United States
Progressive Clinical Research /ID# 259365
San Antonio, Texas, 78229, United States
Complete Dermatology /ID# 258025
Sugar Land, Texas, 77479-3794, United States
Buenos Aires Skin /ID# 258297
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055, Argentina
Instituto de Neumonologia y Dermatologia /ID# 258640
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Psoriahue Med Interdisciplinar /ID# 258641
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Instituto De Investigaciones Clínicas Córdoba /ID# 260244
Córdoba, Córdoba Province, 5000, Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 258639
Buenos Aires, 1061, Argentina
Momentum Clinical Research /ID# 258571
Darlinghurst, New South Wales, 2010, Australia
St George Dermatology & Skin Cancer Centre /ID# 258567
Kogarah, New South Wales, 2217, Australia
Cornerstone Dermatology /ID# 258769
Coorparoo, Queensland, 4151, Australia
Veracity Clinical Research /ID# 258566
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute Inc /ID# 258570
Carlton, Victoria, 3053, Australia
Sinclair Dermatology - Melbourne /ID# 258565
East Melbourne, Victoria, 3002, Australia
The Royal Melbourne Hospital /ID# 258770
Parkville, Victoria, 3050, Australia
Fremantle Dermatology /ID# 260207
Fremantle, Western Australia, 6160, Australia
Universite Libre de Bruxelles - Hopital Erasme /ID# 257314
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 257320
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Brussel /ID# 257325
Jette, Brussels Capital, 1090, Belgium
UZ Gent /ID# 257317
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Delta - campus Torhout /ID# 257321
Torhout, West-Vlaanderen, 8820, Belgium
CHU de Liege /ID# 257316
Liège, 4000, Belgium
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Upeclin Fmb - Unesp /Id# 258046
Botucatu, São Paulo, 18618-686, Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 258105
Campinas, São Paulo, 13034-685, Brazil
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
Rio de Janeiro, 20241-180, Brazil
Hospital Alemao Oswaldo Cruz /ID# 258104
São Paulo, 01323-020, Brazil
Diagnostic Consultative Center Aleksandrovska /ID# 257049
Sofiya, Sofia, 1431, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 257048
Sofiya, Sofia, 1463, Bulgaria
Diagnosis - Consult Centre 20 - Sofia /ID# 257273
Sofiya, Sofia, 1618, Bulgaria
UMHAT Sveti Georgi /ID# 257548
Plovdiv, 4002, Bulgaria
Duplicate_Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseas /ID# 257047
Sofia, 1407, Bulgaria
UMHAT Professor Stoyan Kirkovich /ID# 257051
Stara Zagora, 6000, Bulgaria
Dermatology Research Institute - Blackfoot Trail /ID# 258818
Calgary, Alberta, T2J 7E1, Canada
Beacon Dermatology Inc /ID# 258817
Calgary, Alberta, T3A 2N1, Canada
Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
Edmonton, Alberta, T5J 3S9, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 258814
Surrey, British Columbia, V3R 6A7, Canada
Wiseman Dermatology Research /ID# 258819
Winnipeg, Manitoba, R3M 3Z4, Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
Barrie, Ontario, L4M 7G1, Canada
Medicor Research Inc /ID# 258810
Greater Sudbury, Ontario, P3C 1X3, Canada
Leader Research /ID# 267028
Hamilton, Ontario, L8L 3C3, Canada
Lynderm Research Inc /ID# 258815
Markham, Ontario, L3P 1X2, Canada
JRB Research /ID# 259248
Ottawa, Ontario, K1H 7X3, Canada
SKiN Centre for Dermatology /ID# 258813
Peterborough, Ontario, K9J 5K2, Canada
York Dermatology Clinic & Research Centre /ID# 267026
Richmond Hill, Ontario, L4C 9M7, Canada
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
Waterloo, Ontario, N2J 1C4, Canada
Innovaderm Research Inc. /ID# 258812
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
Québec, Quebec, G1V 4X7, Canada
Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Centro Medico Skin Med SPA /ID# 259314
Las Condes, Region Metropolitana Santiago, 7580206, Chile
Centro Internacional de Estudios Clinicos - CIEC /ID# 259312
Santiago, Region Metropolitana Santiago, 8420383, Chile
Clinica Dermacross /ID# 259311
Vitacura, Region Metropolitana Santiago, 7640881, Chile
Fundacion Innovacion Cardiovascular /ID# 259313
Independencia, Santiago Metropolitan, 8380465, Chile
Beijing Chaoyang Hospital,Capital Medical University /ID# 258912
Beijing, Beijing Municipality, 100020, China
China-Japan Friendship Hospital /ID# 258941
Beijing, Beijing Municipality, 100029, China
Peking University People's Hospital /ID# 258940
Beijing, Beijing Municipality, 100044, China
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 266715
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
Guangzhou, Guangdong, 510080, China
Dermatology Hospital of Southern Medical University /ID# 257118
Guangzhou, Guangdong, 510091, China
The First Affiliated Hospital Of Guangzhou Medical University /ID# 258663
Guangzhou, Guangdong, 510163, China
Zhujiang Hospital of Southern Medical University /ID# 258485
Guangzhou, Guangdong, 510280, China
Shenzhen People's Hospital /ID# 258208
Shenzhen, Guangdong, 518020, China
Shenzhen Second Peoples Hospital /ID# 258060
Shenzhen, Guangdong, 518039, China
Union Hospital - Tongji Medical College /ID# 266737
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University /ID# 260260
Wuhan, Hubei, 430060, China
Dermatology Hospital of Jiangxi Provincial /ID# 259488
Nanchang, Jiangxi, 330030, China
The First Hospital of Jilin University /ID# 257496
Changchun, Jilin, 130021, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 257497
Xi'an, Shaanxi, 710004, China
Shandong Dermatological Hospital /ID# 267520
Jinan, Shandong, 250022, China
Huashan Hospital, Fudan University /ID# 257758
Shanghai, Shanghai Municipality, 200040, China
First Affiliated Hospital of Shanxi Medical University /ID# 259647
Taiyuan, Shanxi, 030001, China
Chengdu Second Municipal People's Hospital /ID# 259492
Chengdu, Sichuan, 610017, China
West China Hospital, Sichuan University /ID# 259560
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital /ID# 259525
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 257260
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119
Hangzhou, Zhejiang, 310020, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
Wenzhou, Zhejiang, 325000, China
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 257151
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 257630
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 257651
Zagreb, City of Zagreb, 10000, Croatia
Specialty Hospital Medico /ID# 257629
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 257632
Split, Split-Dalmatia County, 21000, Croatia
Chu de Nice-Hopital Larchet Ii /Id# 256978
Nice, Alpes-Maritimes, 06202, France
Hopital Ponchaillou /ID# 257520
Rennes, Brittany Region, 35000, France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 257519
Bordeaux, Gironde, 33000, France
CHU Toulouse - Hopital Larrey /ID# 256980
Toulouse, Haute-Garonne, 31400, France
Polyclinique Courlancy /ID# 256977
Reims, Marne, 51100, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256982
Nantes, Pays de la Loire Region, 44000, France
HCL - Hopital Edouard Herriot /ID# 256983
Lyon, Rhone, 69003, France
CHRU de Brest - Hopital Morvan /ID# 256979
Brest, 29200, France
Centre de Sante Sabouraud /ID# 257213
Paris, 75010, France
Hôpital Charles-Nicolle /ID# 256981
Rouen, 76000, France
TUM Klinikum rechts der Isar /ID# 257609
Munich, Bavaria, 81675, Germany
Fachklinik Bad Bentheim /ID# 257741
Bad Bentheim, Lower Saxony, 48455, Germany
Universitaetsklinikum Duesseldorf /ID# 257307
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsklinikum Muenster /ID# 257306
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 257305
Lübeck, Schleswig-Holstein, 23538, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310
Berlin, 10117, Germany
General Hospital Andreas Syggros /ID# 257259
Athens, Attica, 16121, Greece
General Hospital Andreas Syggros /ID# 257262
Athens, Attica, 16121, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 257263
Thessaloniki, 54643, Greece
Papageorgiou General Hospital /ID# 257258
Thessaloniki, 56429, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 257468
Pécs, Baranya, 7624, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 257472
Kecskemét, Bács-Kiskun county, 6000, Hungary
Bagoly Egeszseghaz (Meditres Kft.) /ID# 258032
Kecskemét, Bács-Kiskun county, 6000, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 258552
Szeged, Csongrád megye, 6725, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 257465
Debrecen, Hajdú-Bihar, 4032, Hungary
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 257469
Debrecen, 4031, Hungary
Hadassah Medical Center-Hebrew University /ID# 257946
Jerusalem, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center /ID# 257770
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 257771
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 257769
Haifa, 3525408, Israel
Rabin Medical Center. /ID# 257772
Petah Tikva, 4941492, Israel
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 257501
Florence, Firenze, 50122, Italy
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 257506
L’Aquila, L Aquila, 67100, Italy
IRCCS Istituto Clinico Humanitas /ID# 257500
Rozzano, Lombardy, 20089, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 257504
Naples, Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 258585
Naples, Napoli, 80138, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 257502
Rome, Roma, 00133, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 257513
Rome, Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 257505
Rome, Roma, 00168, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 257499
Bologna, 40138, Italy
ASST degli Spedali Civili di Brescia /ID# 257508
Brescia, 25123, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 257507
Catania, 95123, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 257503
Milan, 20122, Italy
Kurume University Hospital /ID# 257255
Kurume-shi, Fukuoka, 830-0011, Japan
Kitasato University Hospital /ID# 257285
Sagamihara-shi, Kanagawa, 252-0375, Japan
Niigata University Medical & Dental Hospital /ID# 259425
Niigata, Niigata, 951-8520, Japan
Osaka Metropolitan University Hospital /ID# 257256
Osaka, Osaka, 545-8586, Japan
Hamamatsu University Hospital /ID# 257253
Hamamatsu, Shizuoka, 431-3192, Japan
Kyorin University Hospital /ID# 257283
Mitaka-shi, Tokyo, 181-8611, Japan
Tokyo Medical University Hospital /ID# 258132
Shinjuku-ku, Tokyo, 160-0023, Japan
Yamaguchi University Hospital /ID# 257252
Ube-shi, Yamaguchi, 755-8505, Japan
Greenlane Clinical Centre /ID# 258563
Epsom, Auckland, 1051, New Zealand
Clinical Trials New Zealand /ID# 258564
Hamilton, Waikato Region, 3204, New Zealand
Aotearoa Clinical Trials. /ID# 258562
Auckland, 2025, New Zealand
P3 Research Ltd /ID# 259846
Wellington, 6021, New Zealand
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 258242
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
MICS Centrum Medyczne Torun /ID# 257740
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 257534
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 257598
Warsaw, Masovian Voivodeship, 00-716, Poland
Royalderm Agnieszka Nawrocka /ID# 257536
Warsaw, Masovian Voivodeship, 02-962, Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 257531
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 257535
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Angelius Provita /ID# 257916
Katowice, Silesian Voivodeship, 40-615, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centrum Medyczne ALL-MED Badania Kliniczne /ID# 257590
Cracow, 30-033, Poland
Unidade Local de Saude de Almada-Seixal, EPE /ID# 257425
Almada, Setúbal District, 2805-267, Portugal
Hospital CUF Descobertas /ID# 257419
Lisbon, 1998-018, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258554
Porto, 4099-003, Portugal
Santa Cruz Behavioral (SCB) Research Center /ID# 259350
Bayamón, 00961-6910, Puerto Rico
Dr. Samuel Sanchez PSC /ID# 259359
Caguas, 00727, Puerto Rico
Clinical Research Puerto Rico /ID# 259355
San Juan, 00909-1711, Puerto Rico
GCM Medical Group PSC /ID# 258013
San Juan, 00917-3104, Puerto Rico
Mindful Medical Research /ID# 260113
San Juan, 00918-3756, Puerto Rico
Univerzitna nemocnica Bratislava, Nemocnica Stare mesto /ID# 257594
Bratislava, Bratislava Region, 811 07, Slovakia
Derma therapy spol /ID# 257595
Bratislava, Bratislava Region, 851 01, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 257593
Prešov, Presov, 081 01, Slovakia
Kaderma Majtan s.r.o. /ID# 257596
Topoľčany, 955 01, Slovakia
Pusan National University Hospital /ID# 257910
Busan, Busan Gwang Yeogsi, 49241, South Korea
Kyungpook National University Hospital /ID# 257908
Daegu, Daegu Gwang Yeogsi, 41944, South Korea
Chungnam National University Hospital /ID# 267151
Daejeon, Daejeon Gwang Yeogsi, 35015, South Korea
Seoul National University Bundang Hospital /ID# 257906
Seongnam-si, Gyeonggido, 13620, South Korea
Inha University Hospital /ID# 257904
Incheon, Incheon Gwang Yeogsi, 21565, South Korea
Jeonbuk National University Hospital /ID# 267154
Jeonju, Jeonrabugdo, 54907, South Korea
Chungang University Hospital /ID# 267155
Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea
Seoul National University Hospital /ID# 257903
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Konkuk University Medical Center /ID# 257900
Seoul, Seoul Teugbyeolsi, 05030, South Korea
Kyung Hee University Hospital at Gangdong /ID# 257907
Seoul, Seoul Teugbyeolsi, 05278, South Korea
Hallym University Kangdong Sacred Heart Hospital /ID# 257905
Seoul, 05355, South Korea
Hospital Universitari de Bellvitge /ID# 257332
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Fuenlabrada /ID# 257334
Fuenlabrada, Madrid, 28942, Spain
Hospital Santa Creu i Sant Pau /ID# 257034
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia /ID# 257035
Córdoba, 14004, Spain
Hospital Universitario La Paz /ID# 257333
Madrid, 28046, Spain
Hospital Universitario Dr. Peset /ID# 257036
Valencia, 46017, Spain
Karolinska University Hospital Solna /ID# 257094
Solna, Stockholm County, 171 64, Sweden
Diagnostiskt Centrum Hud /ID# 257229
Stockholm, Stockholm County, 111 37, Sweden
CTC GoCo /ID# 257714
Mölndal, Västra Götaland County, 431 53, Sweden
Kaohsiung Chang Gung Memorial Hospital /ID# 258726
Kaohsiung City, Kaohsiung, 833, Taiwan
National Taiwan University Hospital /ID# 257407
Taipei City, Taipei, 100, Taiwan
National Cheng Kung University Hospital /ID# 257409
Tainan, 704, Taiwan
Taipei Veterans General Hosp /ID# 257413
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 258725
Taoyuan, 333, Taiwan
Gulhane Egitim ve Arastirma Hastanesi /ID# 257509
Ankara, Antalya, 06010, Turkey (Türkiye)
Ankara City Hospital /ID# 257417
Ankara, 06800, Turkey (Türkiye)
Gaziantep Universitesi /ID# 257418
Gaziantep, 27310, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi /ID# 257449
Istanbul, 34214, Turkey (Türkiye)
Erciyes University Medical Faculty /ID# 259034
Kayseri, 38039, Turkey (Türkiye)
Velocity Clinical Research Ltd /ID# 257925
High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom
Royal Sussex County Hospital /ID# 257912
Brighton, East Sussex, BN2 5BE, United Kingdom
Gloucestershire Royal Hospital /ID# 257953
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Chelsea and Westminster Hospital /ID# 259128
London, Greater London, SW10 9NH, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 257948
Oxford, Oxfordshire, OX3 9DU, United Kingdom
London North West University Healthcare NHS Trust /ID# 257914
Harrow, HA1 3UJ, United Kingdom
Northern Care Alliance NHS Group /ID# 257952
Salford, M6 8HD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2023
First Posted
August 25, 2023
Study Start
October 11, 2023
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.