A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
2 other identifiers
interventional
1,088
19 countries
184
Brief Summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Typical duration for phase_3
184 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
October 31, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
March 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2028
March 9, 2026
March 1, 2026
2.2 years
October 31, 2024
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 16
Secondary Outcomes (33)
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
At Week 16
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Baseline, at Week 16
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
At Week 16
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Baseline, at Week 16
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
At Week 16
- +28 more secondary outcomes
Study Arms (4)
Zasocitinib Dose A
EXPERIMENTALParticipants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Zasocitinib Dose B
EXPERIMENTALParticipants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Active Comparator Dose C
ACTIVE COMPARATORParticipants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Placebo + Zasoctinib
EXPERIMENTALParticipants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
Interventions
Zasocitinib over-encapsulated tablets.
Eligibility Criteria
You may qualify if:
- Age:
- The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age.
- Disease Characteristics:
- The participant has a diagnosis of PsA.
- The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
- The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
- Medications for PsA:
- The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
You may not qualify if:
- PsA and PsO:
- The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
- The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (189)
AARR- Chandler AZ
Chandler, Arizona, 85225, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85306, United States
First OC Dermatology Research Inc.
Fountain Valley, California, 92708, United States
Purushotham & Akther Kotha MD
La Mesa, California, 91942, United States
Triwest Research Associates LLC
La Mesa, California, 91942, United States
The Cohen Medical Centers
Thousand Oaks, California, 91360-3967, United States
Foothill Arthritis Clinic
Tujunga, California, 91042, United States
Medvin Clinical Research
Whittier, California, 90602-1005, United States
Denver Arthritis Clinic | Denver, CO
Denver, Colorado, 80230, United States
Arthritis & Rheumatic Disease Specialties (AARDS)
Aventura, Florida, 33180, United States
RASF- Clinical Research Center
Boca Raton, Florida, 33486-1390, United States
Clinical Research of West Florida | Clearwater, FL
Clearwater, Florida, 33765, United States
GNP Research, LLC | Hollywood, FL
Cooper City, Florida, 33024, United States
Driven Research LLC
Coral Gables, Florida, 33134-3901, United States
Tectum Medical Research
Davie, Florida, 33024, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, 33016, United States
Bioresearch Partners
Miami, Florida, 33143, United States
HMD Research LLC
Orlando, Florida, 32819, United States
Millennium Research | Ormond Beach, FL
Ormond Beach, Florida, 32174, United States
IRIS Research and Development | Plantation, FL
Plantation, Florida, 33324, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321, United States
Clinical Research of West Florida | Tampa, FL
Tampa, Florida, 33606, United States
Marietta Rheumatology Associates
Marietta, Georgia, 30060, United States
GSCP/CIS
Orland Park, Illinois, 60467, United States
Greater Chicago Specialty Physicians LLC/CIS
Schaumburg, Illinois, 60195, United States
Accurate Clinical Research, Inc. | Lake Charles
Lake Charles, Louisiana, 70605, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
Henry Ford Health System-Rheumatology Department
Detroit, Michigan, 48202, United States
Michigan Rheumatology Group, P.C. - Grand Blanc Office
Grand Blanc, Michigan, 48439-2451, United States
Ash Research Clinic - Howell
Howell, Michigan, 48843, United States
June DO, PC Private Practice - Dr. Justus Fiechtner
Lansing, Michigan, 48911-4285, United States
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, 48081, United States
Saint Louis Rheumatology
St Louis, Missouri, 63119, United States
Albuquerque Center for Rheumatology PC
Albuquerque, New Mexico, 87102-1710, United States
Santa Fe Rheumatology
Santa Fe, New Mexico, 87505-1102, United States
NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department
Brooklyn, New York, 11201, United States
Accellacare of Hickory
Hickory, North Carolina, 28602, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
Cleveland, Ohio, 44106, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610-3206, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Accurate Clinical Research
Baytown, Texas, 77521, United States
Novel Research | Bellaire Location
Houston, Texas, 77024, United States
Novel Research | Bellaire Location
Houston, Texas, 77024, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Introscience Research | Northwest Houston Arthritis Center - Houston, TX
Houston, Texas, 77090, United States
West Texas Clinical Research
Lubbock, Texas, 79424, United States
Southwest Rheumatology Research, LLC | Mesquite, TX
Mesquite, Texas, 75150, United States
Clinical Investigations of Texas
Plano, Texas, 75075, United States
Arthritis Northwest, PLLC | Spokane, WA
Spokane, Washington, 99204, United States
Medical College of Wisconsin | Department of Medicine - Rheumatology Division
Milwaukee, Wisconsin, 53226-3522, United States
Université Libre de Bruxelles
Anderlecht, Brussels Capital, 1070, Belgium
University Hospital Ghent
Ghent, Flanders, 9000, Belgium
ReumaClinic Genk
Genk, Limburg, 3600, Belgium
St Pierre Brussels
Brussels, 1000, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Sofia-Grad, 1463, Bulgaria
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia
Sofia, Sofia-Grad, 1606, Bulgaria
Centre of Rheumatology St. Irina
Sofia, Sofia-Grad, 1784, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
AES Partner Site -Plovdiv
Plovdiv, 4000, Bulgaria
Medical Center Artmed OOD | Plovdiv, Bulgaria
Plovdiv, 4000, Bulgaria
Diagnostic- Consultative Center- 1- Ruse EOOD
Rousse, 7002, Bulgaria
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria
Stara Zagora, 6000, Bulgaria
Medical Center Zara-Med EOOD
Stara Zagora, 6000, Bulgaria
El Centro de Estudios Reumatologicos (CER)
Providencia, Santiago Metropolitan, 7500000, Chile
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
Centro de Estudios Clinicos
Santiago, 8320000, Chile
CTR Estudios
Santiago, 8320000, Chile
Centro Internacional de Estudios Clínicos
Santiago, 8420383, Chile
Medicinski Centar Kuna and Peric
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
University Hospital Centre Split
Split, 21000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Revmatologie s.r.o. | Brno, Czech Republic
Brno, Czech Rep, 63800, Czechia
L.K.N. Arthrocentrum, s.r.o. - Revmatologicka
Hlučín, Czech Rep, 92307, Czechia
Clintrial s.r.o. | Prague, Czech Republic
Prague, Czech Rep, 100 00, Czechia
Praglandia | Prague, Czech Republic
Prague, Czech Rep, 150 00, Czechia
MEDICAL Plus s.r.o.
Uherské Hradiště, Czech Rep, 68601, Czechia
CCR Ostrava
Ostrava, Moravskoslezský kraj, 702 00, Czechia
Pv Medical Services
Zlín, NAP, 760 01, Czechia
Revmatologicky ustav | Clinical Evaluation Department
Prague, Prague, 12800, Czechia
Pratia Pardubice a.s.
Pardubice, 53002, Czechia
Innomedica OU | Tallinn, Estonia
Tallinn, Harju, 10117, Estonia
Center for Clinical and Basic Research
Tallinn, Harju, 10128, Estonia
Clinical Research Centre | Tartu, Estonia
Tartu, Tartu, 50106, Estonia
North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department
Tallinn, 13419, Estonia
MediTrials OÜ
Tartu, 50708, Estonia
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
Rheumzentrum Prof.Dr.med.Gunther Neeck
Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany
Rheumazentrum Ratingen-Studienambulanz
Ratingen, North Rhine-Westphalia, 40878, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, 4103, Germany
Rheumatologische Schwerpunktpraxis | Berlin, Germany
Berlin, 12161, Germany
Städtisches Klinikum Dresden
Dresden, 01067, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
Hamburg, 20095, Germany
Medicover MVZ München Ost
München, 81667, Germany
Porcika Klinika
Hódmezővásárhely, Csongrad-Csanad, 6800, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrad-Csanad, 6720, Hungary
CMed Rehabilitacios es Diagnosztikai Kozpont
Székesfehérvár, Fejér, 8000, Hungary
Qualiclinic | Budapest, Hungary
Budapest, 1036, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center
Székesfehérvár, 8000, Hungary
Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary
Veszprém, 8200, Hungary
Assuta Ashdod Medical Center
Ashdod, Southern District, 7747629, Israel
Barzilai Medical Center | Rheumatology Department
Ashkelon, 7830604, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Galilee Medical Center | Rheumatology Unit
Nahariya, 2210001, Israel
The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, Ancona, 60126, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Policlinico Agostino Gemelli, UOC Reumatology
Rome, Lazio, 168, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Lombardy, 20122, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Azienda Ospedale Università Padova
Padua, Veneto, 35128, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
Liepāja, 3401, Latvia
ORTO Clinic | Rheumatology Department
Riga, LV-1005, Latvia
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
Mexicali, Estado de Baja California, 21200, Mexico
iBiomed Guadalajara
Zapopan, Guadalajara, 44160, Mexico
Centro Integral en Reumatologia, S.A. de C.V.
Guadalajara, Jalisco, 44160, Mexico
Private Practice - Dr. Delfina Villanueva Quintero
Guadalajara, Jalisco, 44600, Mexico
Consultorio de Reumatologia
Gustavo Adolfo Madero, Mexico City, 07760, Mexico
HMG Hospital Coyoacan
Mexico City, Mexico City, 06720, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, Mexico City, 11850, Mexico
Kohler and Milstein Research Yucatan
Mérida, Yucatán, 97070, Mexico
Hospitales Star Medica
Mérida, Yucatán, 97133, Mexico
Office of Cesar F. Pacheco-Tena, MD
Chihuahua City, 31000, Mexico
CGM Research Trust
Christchurch Central, Christchurch, 8013, New Zealand
Aotearoa Clinical Trials
Auckland, North Island, 2025, New Zealand
North Shore Hospital
Auckland, North Island, 6022, New Zealand
Porter Rheumatology Ltd
Nelson, South Island, 7010, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 8011, New Zealand
Pratia Poznań
Poznan, Greater Poland Voivodeship, 60-192, Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Centrum Medyczne Katowice - PRATIA
Katowice, Lower Silesian Voivodeship, 40-081, Poland
RCMed | Sochaczew, Poland
Sochaczew, Masovian Voivodeship, 96-500, Poland
Rheuma Medicus | Warsaw, Poland
Warsaw, Masovian Voivodeship, 02-118, Poland
MTZ Clinical Research Powered by PRATIA
Warsaw, Masovian Voivodeship, 02-172, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic
Warsaw, Masovian Voivodeship, 02-637, Poland
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665, Poland
ETG Warszawa Sp. z o.o.
Warsaw, Masovian Voivodeship, 02-677, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, Opole Voivodeship, 45-819, Poland
INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland
Bialystok, Podlaskie Voivodeship, 15-077, Poland
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, 15-077, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Bif-Med s.c. NZOZ
Bytom, Silesian Voivodeship, 41-902, Poland
MICS Centrum Medyczne Torun
Torun, Silesian Voivodeship, 87-100, Poland
UNICA CR sp. z.o. o.
Dąbrówka, Warmian-Masurian Voivodeship, 62-069, Poland
Ambulatorium Sp. z o.o.
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Etyka Osrodek Badan Klinicznych | Olsztyn, Poland
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
Poznan, Wielkopolska, 60-324, Poland
Reumedika | Poznan, Poland
Poznan, Wlkp, 60-446, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland
Poznan, Woj. Wielkopolskie, 61-397, Poland
Santa Familia PTG Lodz | Lodz, Poland
Lodz, 90-302, Poland
FutureMeds | Lodz Center - Lodz, Poland
Lodz, 91-363, Poland
Twoja Przychodnia | Nowa Sol, Poland
Nowa Sól, 67-100, Poland
FutureMeds Wroclaw
Wroclaw, 53-673, Poland
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
Coimbra, Barcelona, 3004-561, Portugal
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
Ponte de Lima, Barcelona, 4990-041, Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
Vila Nova de Gaia, New Mexico, 4434-502, Portugal
Hospital Garcia de Orta
Almada, 2805-267, Portugal
Instituto Portugues de Reumatologia
Lisbon, 1050-034, Portugal
Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department
Lisbon, 1649-035, Portugal
Centro Reumatologico de Caguas | Caguas, PR
Caguas, 00725, Puerto Rico
GCM Medical Group, PSC | San Juan, PR
San Juan, 00917, Puerto Rico
The Catholic University of Korea
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital | Clinical Trial Center
Suwon, Gyeonggido, 16499, South Korea
Asan Medical Center
Seoul, 05505, South Korea
SMG - SNU Boramae Medical Center
Seoul, 07061, South Korea
Kyung Hee University Hospital
Seoul, 2447, South Korea
Hospital Universitario de Badajoz
Mérida, Badajoz, 06006, Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department
Santiago de Compostela, Galicia, 15706, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
National Cheng Kung University
Tainan, Tainan City, 701, Taiwan
National Taiwan University Hospital
Zhong Zheng Qu, Taipei City, 100, Taiwan
Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department
New Taipei City, 220, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 4, 2024
Study Start
March 3, 2025
Primary Completion (Estimated)
May 18, 2027
Study Completion (Estimated)
January 28, 2028
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.