A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
Start Up
A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
2 other identifiers
interventional
675
25 countries
145
Brief Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. 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 clinical 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 Aug 2024
Longer than P75 for phase_3
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 17, 2024
CompletedStudy Start
First participant enrolled
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
April 1, 2026
March 1, 2026
5.9 years
June 12, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US)
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
At Week 16
Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points (US and China only, descriptive)
The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: * 0 - Clear: No inflammatory signs of AD; * 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; * 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; * 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; * 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Week 16
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 Week 172
Secondary Outcomes (12)
Percentage of Participants Achieving a 75% Reduction from Baseline in EASI 75 Score (US)
At Week 16
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points
At Week 16
Percentage of participants achieving a 50% reduction from Baseline in EASI 50 score
At Week 16
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points
At Week 52
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points
At Week 160
- +7 more secondary outcomes
Study Arms (2)
Dupi-IR Cohort
EXPERIMENTALParticipants in this cohort will receive upadacitinib medium dose.
Randomized Cohort
EXPERIMENTALParticipants in the Randomized Cohort will be randomized to receive either medium dose upadacitinib daily adult equivalent dose, low dose upadacitinib daily adult equivalent dose or dupilumab every 2 weeks or 4 weeks (at the label-indicated dose and frequency).
Interventions
Oral Tablet or Oral Solution
Eligibility Criteria
You may qualify if:
- A minimum weight of 10 kg and weight and height \> 5th percentile for their age according to local standard growth charts at the Baseline Visit.
- Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
- Eczema Area and Severity Index (EASI) score \>= 16; vIGA-AD score \>= 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the Randomized Cohort should have severe AD \[vIGA-AD = 4\]); \>= 10% Body Surface Area of AD involvement at the Baseline Visit; and Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) \>= 4.
- Participant must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual participant. All applicable criteria for each individual participant should be reported):
- To be included in the Randomized Cohort (Note: Participants must have severe AD \[vIGA-AD = 4\] in countries where dupilumab is approved only for severe AD.):
- \[For all countries except US\] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, Scoring Atopic Dermatitis (SCORAD) \> 50, EASI score \> 21, or vIGA-AD \> 3).
- For dupilumab-naïve participants: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- History of inadequate response to 2 or more courses of oral corticosteroid therapy given for \>= 14 days within 6 months prior to Screening or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation.
- For dupilumab-exposed participants: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges \[not safety- or efficacy-related\] precluding the participants continued access to dupilumab).
- To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort:
- Previous inadequate response or intolerance to dupilumab OR
- Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI.
You may not qualify if:
- Current or past history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or which would interfere with the appropriate assessment of AD lesions.
- Have used topical treatments for AD (except for topical emollient treatments) including but not limited to TCS, TCI, or topical phosphodiesterase type 4 (PDE-4) inhibitors, within 7 days of the Baseline Visit or any the following prohibited concomitant AD treatments within the specified timeframes below prior to the Baseline Visit:
- Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks;
- Dupilumab within 8 weeks;
- Targeted biologic treatments (other than dupilumab) within 5 half-lives (if known) or within 12 weeks, whichever is longer;
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
- Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality.
- For Randomized Cohort: diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (148)
Applied Research Center Of Arkansas /ID# 268547
Little Rock, Arkansas, 72205, United States
Stanford University School of Medicine - Palo Alto /ID# 269622
Palo Alto, California, 94304, United States
Integrative Skin Science and Research /ID# 265108
Sacramento, California, 95815, United States
Clearlyderm Dermatology - West Boca /ID# 266323
Boca Raton, Florida, 33428, United States
Pediatric Skin Research /ID# 266308
Coral Gables, Florida, 33146, United States
Neoclinical Research - Hialeah /ID# 269694
Hialeah, Florida, 33016, United States
Cleaver Medical Group Dermatology /ID# 265099
Dawsonville, Georgia, 30534, United States
Aeroallergy Research Laboratory /ID# 267247
Savannah, Georgia, 31406, United States
Treasure Valley Medical Research /ID# 266838
Boise, Idaho, 83706, United States
Northwestern University Feinberg School of Medicine /ID# 265117
Chicago, Illinois, 60611-2927, United States
Sneeze Wheeze & Itch Associates /ID# 267238
Normal, Illinois, 61761, United States
Dawes Fretzin, LLC /ID# 265097
Indianapolis, Indiana, 46256, United States
Equity Medical, LLC /ID# 268270
Bowling Green, Kentucky, 42104, United States
Maryland Allergy & Asthma Center /ID# 268032
Lanham, Maryland, 20706, United States
DermAssociates - Rockville /ID# 266457
Rockville, Maryland, 20850, United States
Washington University School of Medicine - St. Louis /ID# 268545
St Louis, Missouri, 63130, United States
Skin Specialists /ID# 266331
Omaha, Nebraska, 68144, United States
DOCS Clinical Research - Canal Winchester /ID# 268271
Canal Winchester, Ohio, 43110-2069, United States
Wright State Physicians Health Center /ID# 268841
Fairborn, Ohio, 45324, United States
Oregon Health and Science University /ID# 266483
Portland, Oregon, 97239, United States
Medical University of South Carolina /ID# 265113
Charleston, South Carolina, 29425, United States
International Clinical Research - Tennessee /ID# 268548
Murfreesboro, Tennessee, 37130, United States
Arlington Research Center, Inc /ID# 266330
Arlington, Texas, 76011, United States
3A Research - East location /ID# 267622
El Paso, Texas, 79925, United States
Prime Clinical Research - Mansfield - East Broad Street /ID# 268042
Mansfield, Texas, 76063, United States
Texas Dermatology and Laser Specialists /ID# 267249
San Antonio, Texas, 78218, United States
Progressive Clinical Research - San Antonio /ID# 267262
San Antonio, Texas, 78229, United States
Jordan Valley Dermatology & Research Center /ID# 267092
South Jordan, Utah, 84095, United States
West Virginia University Hospitals /ID# 265114
Morgantown, West Virginia, 26506, United States
Wisconsin Medical Center /ID# 267236
Milwaukee, Wisconsin, 53226, United States
Sanatorio 9 de Julio /ID# 267678
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Conexa Investigacion Clinica /ID# 268728
Buenos Aires, 1012, Argentina
Instituto de Neumonología y Dermatología /ID# 266146
Buenos Aires, 1425, Argentina
Psoriahue - Buenos Aires /ID# 267737
Buenos Aires, 1425, Argentina
The Children's Hospital at Westmead /ID# 265430
Westmead, New South Wales, 2145, Australia
Monash Health - Monash Medical Centre /ID# 267149
Clayton, Victoria, 3168, Australia
Institute for Skin, Health and Immunity /ID# 266158
Mitcham, Victoria, 3132, Australia
Medizinische Universitaet Graz /ID# 262741
Graz, Styria, 8010, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427
Salzburg, 5020, Austria
Medizinische Universitaet Wien /ID# 265417
Vienna, 1090, Austria
Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 267455
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 266965
Campinas, São Paulo, 13034-685, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 266964
Ribeirão Preto, São Paulo, 14049-900, Brazil
Clinica de Alergia Martti Antila /ID# 266197
Sorocaba, São Paulo, 18040-425, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 266667
São Paulo, 05403-000, Brazil
UMHAT Alexandrovska EAD /ID# 265256
Sofiya, Sofia, 1431, Bulgaria
Medical Center Cordis /ID# 265250
Pleven, 5800, Bulgaria
Dermatology Research Institute - Blackfoot Trail /ID# 266744
Calgary, Alberta, T2J 7E1, Canada
Rejuvenation Dermatology - Edmonton Downtown /ID# 267871
Edmonton, Alberta, T5J 3S9, Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 265395
Vancouver, British Columbia, V6H 3N1, Canada
Maritime Dermatology /ID# 267359
Halifax, Nova Scotia, B3K 5R3, Canada
Leader Research /ID# 266745
Hamilton, Ontario, L8L 3C3, Canada
Triple A Lab Inc /ID# 266615
Hamilton, Ontario, L8S 1G5, Canada
Lynderm Research Inc /ID# 267006
Markham, Ontario, L3P 1X2, Canada
Allergy Research Canada /ID# 270230
Niagara Falls, Ontario, L2H 1H5, Canada
DermAtelier on Avenue /ID# 267850
Toronto, Ontario, M5M 3Z8, Canada
Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831
Montreal, Quebec, H3T 1C5, Canada
Clinica Dermacross /ID# 266309
Vitacura, Region Metropolitana Santiago, 7640881, Chile
Fundacion Innovacion Cardiovascular /ID# 266742
Independencia, Santiago Metropolitan, 8380465, Chile
Beijing Children's Hospital /ID# 266350
Beijing, Beijing Municipality, 100045, China
Children's Hospital Affiliated to Chongqing Medical University /ID# 266876
Yuzhong District, Chongqing Municipality, 400015, China
Xiamen Children's Hospital /ID# 266384
Xiamen, Fujian, 361006, China
Shenzhen Children's Hospital /ID# 266401
Shenzhen, Guangdong, 518026, China
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 266832
Zhengzhou, Henan, 450018, China
Hunan Children's Hospital /ID# 266365
Changsha, Hunan, 410007, China
Dalian Women and Children's Medical Group /ID# 266675
Dalian, Liaoning, 116012, China
Chengdu Women and Children Center Hospital /ID# 266402
Chengdu, Sichuan, 610091, China
Kunming Childrens Hospital /ID# 266555
Kunming, Yunnan, 650103, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU /ID# 266708
Wenzhou, Zhejiang, 325027, China
Klinika za dječje bolesti Zagreb /ID# 264936
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika DermaPlus /ID# 265724
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 265070
Zagreb, City of Zagreb, 10000, Croatia
Specialty Hospital Medico /ID# 266116
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki Bolnicki Centar KBC Split /ID# 265359
Split, Split-Dalmatia County, 21000, Croatia
CHU Toulouse - Hopital Larrey /ID# 255048
Toulouse, Haute-Garonne, 31400, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 265455
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHU Bordeaux - Hopital Pellegrin /ID# 266818
Bordeaux, Nouvelle-Aquitaine, 33076, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265449
Nantes, Pays de la Loire Region, 44000, France
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing /ID# 267327
Clermont-Ferrand, Puy-de-Dome, 63100, France
CHU Amiens-Picardie Site Sud /ID# 255083
Amiens, Somme, 80054, France
AP-HP - Hopital Necker /ID# 255050
Paris, 75015, France
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448
Argenteuil, Île-de-France Region, 95107, France
Universitaetsklinikum Erlangen /ID# 255168
Erlangen, Bavaria, 91054, Germany
Fachklinik Bad Bentheim /ID# 255165
Bad Bentheim, Lower Saxony, 48455, Germany
Universitaetsklinikum Muenster /ID# 255166
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167
Dresden, Saxony, 01307, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411
Berlin, 10117, Germany
DermaMed Research - Oroshaza /ID# 266995
Orosháza, Bekes County, 5900, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 265653
Szeged, Csongrád megye, 6725, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 265331
Debrecen, Hajdú-Bihar, 4032, Hungary
Schneider Childrens Medical Center of Israel /ID# 265617
Petah Tikva, Central District, 4920235, Israel
HaEmek Medical Center /ID# 266416
Afula, Haifa District, 1834111, Israel
Hadassah Medical Center-Hebrew University /ID# 255041
Jerusalem, Jerusalem, 91120, Israel
Soroka Medical Center /ID# 265251
Beersheba, Southern District, 8410101, Israel
The Chaim Sheba Medical Center /ID# 265254
Ramat Gan, Tel Aviv, 5265601, Israel
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070
Rome, Roma, 00161, Italy
Ospedale Pediatrico Bambino Gesù /ID# 266118
Rome, Roma, 00165, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255118
Bologna, 40138, Italy
Eukarya PharmaSite /ID# 265274
Monterrey, Nuevo León, 64718, Mexico
Arke Smo Sa de Cv /Id# 266650
Veracruz, 91910, Mexico
Amsterdam UMC, locatie AMC /ID# 265406
Amsterdam, North Holland, 1105 AZ, Netherlands
Erasmus Medisch Centrum /ID# 265408
Rotterdam, South Holland, 3015 CE, Netherlands
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 265457
Poznan, Greater Poland Voivodeship, 60-693, Poland
MICS Centrum Medyczne Torun /ID# 265454
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 266030
Krakow, Lesser Poland Voivodeship, 31-011, Poland
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 267490
Warsaw, Masovian Voivodeship, 00-716, Poland
Clinical Research Group Sp. z o.o. /ID# 266924
Warsaw, Masovian Voivodeship, 01-142, Poland
Klinika Ambroziak Dermatologia /ID# 265458
Warsaw, Masovian Voivodeship, 02-953, Poland
Royalderm Agnieszka Nawrocka /ID# 266606
Warsaw, Masovian Voivodeship, 02-962, Poland
NZOZ Specjalistyczny Osrodek Dermatologiczny Dermal /ID# 266613
Bialystok, Podlaskie Voivodeship, 15-453, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 265451
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Angelius Provita /ID# 265456
Katowice, Silesian Voivodeship, 40-615, Poland
Unidade Local de Saude de Coimbra, EPE /ID# 266115
Coimbra, 3000-075, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 266112
Porto, 4099-003, Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 266111
Porto, 4200-319, Portugal
Clinical Research Investigator Group, LLC /ID# 268366
Bayamón, 00960, Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 264234
Carolina, 00985, Puerto Rico
National University Hospital /ID# 265685
Singapore, 119074, Singapore
KK Women's and Children's Hospital /ID# 266519
Singapore, 229899, Singapore
Narodny Ustav Detskych Chorob /ID# 265253
Bratislava, Bratislava Region, 831 01, Slovakia
ALERSA, s.r.o. /ID# 266245
Košice, Košice Region, 040 01, Slovakia
Univerzitna nemocnica L. Pasteura Kosice /ID# 265239
Košice, Košice Region, 040 01, Slovakia
Fakultna nemocnica Trnava /ID# 265245
Trnava, 917 02, Slovakia
Univerzitna nemocnica Martin /ID# 265947
Martin, Žilina Region, 036 01, Slovakia
Korea University Ansan Hospital /ID# 264169
Ansan-si, Gyeonggido, 15355, South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 264171
Bucheon-si, Gyeonggido, 14584, South Korea
Chungang University Hospital /ID# 266383
Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea
Seoul National University Hospital /ID# 264176
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Konkuk University Medical Center /ID# 264178
Seoul, Seoul Teugbyeolsi, 05030, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 267318
Seoul, Seoul Teugbyeolsi, 07441, South Korea
Hospital Sant Joan de Deu /ID# 255287
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital General Universitario Gregorio Maranon /ID# 255288
Madrid, 28007, Spain
Hospital Universitario La Paz /ID# 255286
Madrid, 28046, Spain
Consorci Hospital General Universitario de Valencia /ID# 255289
Valencia, 46014, Spain
Hospital Universitario Miguel Servet /ID# 255290
Zaragoza, 50009, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 267791
Kaohsiung City, Kaohsiung, 833, Taiwan
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 266349
New Taipei City, 236, Taiwan
National Taiwan University Hospital /ID# 265510
Taipei, 100, Taiwan
Taipei Veterans General Hospital /ID# 265507
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 263664
Taoyuan, 333, Taiwan
Derriford Hospital and the Royal Eye Infirmary /ID# 266980
Plymouth, Devon, PL6 8DH, United Kingdom
St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 265237
London, Greater London, SE1 7EH, United Kingdom
Chelsea and Westminster Hospital /ID# 266389
London, Greater London, SW10 9NH, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 266984
London, Greater London, SW17 0QT, United Kingdom
University Hospital Southampton /ID# 266655
Southampton, Hampshire, SO16 6YD, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 265219
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Manchester University NHS Foundation Trust /ID# 267693
Manchester, M9 2AA, United Kingdom
Royal Victoria Infirmary /ID# 265238
Newcastle upon Tyne, NE1 4LP, 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
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 17, 2024
Study Start
August 19, 2024
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
April 1, 2026
Record last verified: 2026-03
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.