A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
2 other identifiers
interventional
1,108
16 countries
217
Brief Summary
The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 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 Nov 2023
217 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 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2025
CompletedNovember 20, 2025
November 1, 2025
1.1 years
October 25, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Baseline, Week 16
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Baseline, Week 16
Secondary Outcomes (52)
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo
Baseline, Week 16
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
Week 16
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
Week 16
Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
Baseline, Week 16
Percentage of Participants Achieving PASI-75 at Week 4 Comparing TAK-279 Against Placebo
Week 4
- +47 more secondary outcomes
Study Arms (3)
TAK-279
EXPERIMENTALPlacebo
PLACEBO COMPARATORApremilast
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Plaque psoriasis for at least 6 months.
- Moderate to severe disease.
- Candidate for phototherapy or systemic therapy.
You may not qualify if:
- Other forms of psoriasis.
- History of recent infection.
- Prior exposure to TAK-279 or active comparator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (217)
Total Dermatology
Birmingham, Alabama, 35205, United States
Cahaba Dermatology Skin Health Center
Hoover, Alabama, 35244-2111, United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006-2722, United States
Noble Clinical Research
Tucson, Arizona, 85704-7892, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916-6103, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913-6475, United States
Zenith Research, Inc.
Beverly Hills, California, 90211-1705, United States
UNISON Clinical Trials (Shahram Jacobs md inc.)
Encino, California, 91436-2428, United States
First OC Dermatology Research Inc.
Fountain Valley, California, 92708-3701, United States
Long Beach Research Institute, LLC
Long Beach, California, 90805-4587, United States
Metropolis Dermatology Downtown LA - Probity - PPDS
Los Angeles, California, 90017-5310, United States
Northridge Clinical Trials
Northridge, California, 91325-4122, United States
TCR Medical Corporation
San Diego, California, 92123-1523, United States
University Clinical Trials
San Diego, California, 92123, United States
Dermatology Institute and Skin Care Center
Santa Monica, California, 90404-2216, United States
Revival Research Corporation - Florida - ClinEdge - PPDS
Doral, Florida, 33122-1902, United States
Florida Academic Centers Research
Miami, Florida, 33136-1003, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014-5602, United States
FXM Research Miramar
Miramar, Florida, 33027-4714, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172-2741, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, 33607-6429, United States
Olympian Clinical Research - 6331 Memorial Hwy
Tampa, Florida, 33615, United States
Divine Dermatology and Aesthetics, LLC
Atlanta, Georgia, 30315-2042, United States
Advanced Medical Research, PC
Atlanta, Georgia, 30342-1418, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217-3861, United States
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, 60077-1049, United States
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, 47129-2201, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217-1444, United States
DS Research of Kentucky
Louisville, Kentucky, 40241-6162, United States
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605-1213, United States
Lawrence J Green, MD LLC
Rockville, Maryland, 20850-6363, United States
Allcutis Research LLC
Beverly, Massachusetts, 01915, United States
Beacon Clinical Research LLC
Brockton, Massachusetts, 02301, United States
David Fivenson MD Dermatology PLLC
Ann Arbor, Michigan, 48103-9746, United States
University of Michigan Hospital - 1500 E Medical Center Dr
Ann Arbor, Michigan, 48109-5360, United States
Oakland Hills Dermatology - 3400 Auburn Rd
Auburn Hills, Michigan, 48326-3396, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432-3134, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Vivida Dermatology - Flamingo Rd - Probity - PPDS
Las Vegas, Nevada, 89119-5190, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, 03801-03804, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Mount Sinai Doctors -234 E 85th St
New York, New York, 10029-6504, United States
Sadick Research Group
New York, New York, 10075-0385, United States
Derm Research Center of NY
Stony Brook, New York, 11790, United States
Montefiore Dermatology - BRANY - PPDS
The Bronx, New York, 10467-1402, United States
Duke Dermatology Clinic
Durham, North Carolina, 27710-4000, United States
The Skin Surgery Center for Clinical Research - Objective Health - PPDS
Winston-Salem, North Carolina, 27103-7109, United States
Wake Forest Baptist Health Department of Dermatology - 4618 Country Club Rd
Winston-Salem, North Carolina, 27157-0001, United States
ClinOhio Research Services
Columbus, Ohio, 43213-4445, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124-4005, United States
Oregon Medical Research Center PC
Portland, Oregon, 97239-4501, United States
University of Pittsburgh Medical Center-3601 5th Ave
Pittsburgh, Pennsylvania, 15213-3403, United States
Cumberland Skin Center for Clinical Research - Objective Health - PPDS
Hermitage, Tennessee, 37076-3497, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215-2888, United States
Arlington Research Center
Arlington, Texas, 76011-3800, United States
UT Physicians Dermatology - Bellaire Station
Bellaire, Texas, 77401-3535, United States
Modern Research Associates
Dallas, Texas, 75231-6077, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
Pflugerville, Texas, 78660-6148, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218-3128, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229-3409, United States
Houston Center for Clinical Research, LLC
Sugar Land, Texas, 77479-1001, United States
Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
Webster, Texas, 77598-4927, United States
Center For Clinical Studies,LTD. LLP - 451 N Texas Ave
Webster, Texas, 77598-4927, United States
Virginia Clinical Research - 6160 Kempsville Cir
Norfolk, Virginia, 23507, United States
Conexa Investigación Clínica S.A.
Buenos Aires, C1012, Argentina
STAT Research S.A.
Buenos Aires, C1023AAB, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, C1425BEA, Argentina
Centro de Investigacion Clínica - CEDIC
Ciudad Autónomade Buenos Aires, C1060ABN, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, T4000, Argentina
Medical Center Unimed EOOD
Sevlievo, Gabrovo, 5400, Bulgaria
Medical Center Asklepii OOD
Dupnitsa, Kyustendil, 2600, Bulgaria
MBAL Skin Systems, Doganovo
Elin Pelin, Sofia, 2115, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431, Bulgaria
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Sofia-Grad, 1463, Bulgaria
Medical Center Hera EOOD
Sofia, Sofia-Grad, 1510, Bulgaria
Diagnostic Consultative Center XXVIII - Sofia - EOOD
Sofia, Sofia-Grad, 1592, Bulgaria
Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD
Sofia, Sofia-Grad, 1606, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, 1606, Bulgaria
MC Comac Medical - IRN - PPDS
Sofia, Sofia-Grad, 1612, Bulgaria
Multiprofile Hospital for Active Treatment - Dobrich AD
Dobrich, 9300, Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, 5300, Bulgaria
Diagnostic Consultative Center Sveti Georgi EOOD
Haskovo, 6300, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
Medical Center Exacta Medica - Vasil Levski 60
Pleven, 5801, Bulgaria
University Multiprofile Hospital for Active Treatment -Dr. Georgi Stranski -Gen. V. Vazov Str 91
Pleven, Bulgaria
Dermatology Research Institute, Inc. - Probity - PPDS
Calgary, Alberta, T3A 2N1, Canada
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, T6G 1C2 Canada, Canada
VIDA Dermatology - Probity - PPDS
Edmonton, Alberta, T6H 4J8, Canada
CaRe Clinic-Red Deer
Red Deer, Alberta, T4N 7C3, Canada
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, R3E 0V9, Canada
Brunswick Dermatology Centre - Probity - PPDS
Fredericton, New Brunswick, E3B 1G9, Canada
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
Hamilton, Ontario, L8L 3C3, Canada
Dermatrials Research
Hamilton, Ontario, L8N 1Y2, Canada
DermEffects - Probity - PPDS
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc - Probity - PPDS
Markham, Ontario, L3P 1X3, Canada
DermEdge Research - Probity - PPDS
Mississauga, Ontario, L4Y 4C5, Canada
The Centre for Clinical Trials Inc. - Probity - PPDS
Oakville, Ontario, L6J 7W5, Canada
Oshawa Clinic-117 King St
Oshawa, Ontario, L1R 1R7, Canada
SKiN Centre for Dermatology - Peterborough - Probity - PPDS
Peterborough, Ontario, K9J 1Z2, Canada
Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
Richmond Hill, Ontario, L4B 1M5, Canada
Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
Richmond Hill, Ontario, L4C 9M7, Canada
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, M3B 0A7, Canada
Toronto Research Centre - Probity - PPDS
Toronto, Ontario, M3H 5Y8, Canada
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research - Probity - PPDS
Windsor, Ontario, N8X 3V6, Canada
Siena Medical Research
Westmount, Quebec, H3Z 2S6, Canada
Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS
Saskatoon, Saskatchewan, S7K 0H6, Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, 310016, China
Huashan Hospital Fudan University - PPDS
Shanghai, 200040, China
Dermamedica, s.r.o. - Kozni Ambulance Nachod
Náchod, Královéhradecký kraj, 547 01, Czechia
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezský kraj, 741 01, Czechia
CCR Ostrava s.r.o.
Ostrava, Moravskoslezský kraj, 702 00, Czechia
Praglandia s.r.o.
Prague, Ohio, 150 00, Czechia
Dermskin s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto, 100 00, Czechia
Pratia Brno s.r.o. - PRATIA - PPDS
Brno, South Moravian, 602 00, Czechia
Pratia Pardubice a.s. - PRATIA - PPDS
Pardubice, 530 02, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
Prague, 110 00, Czechia
Centre Hospitalier Le Mans
Le Mans, Ohio, 72037, France
AP-HM- Hôpital de La Timone
Marseille, 13885, France
Hôpital Charles Nicolle-1 Rue de Germont
Rouen, 76031, France
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
Klinische Forschung Dresden GmbH (KFGN) - PRATIA - PPDS
Dresden, Saxony, 01069, Germany
Praxis fur Dermatologie and Venerologie
Dresden, Saxony, 01097, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, 07548, Germany
FutureMeds - Berlin - PPDS
Berlin, 10629, Germany
Dermatologikum Hamburg
Hamburg, 20354, Germany
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, 24148, Germany
Hospital A.Syggros
Athens, Attica, 161 21, Greece
University General Hospital ''ATTIKON''
Chaïdári, Attica, 124 62, Greece
University Hospital of Ioannina
Loannina, Loannina, 455 00, Greece
Hospital Of Skin And Venereal Diseases of Thessaloniki
Thessaloniki, 546 43, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29, Greece
Szegedi Tudomanyegyetem
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032, Hungary
Allergo-Derm Bakos Kft- Szolnok-Baross utca 20
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, Somogy County, 7400, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Szombathely, Vas County, 9700, Hungary
Pécsi Tudomanyegyetem - Vasvari Pal u.
Pécs, 7632, Hungary
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Jerusalem, 9112002, Israel
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, 52621, Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS 27004
Tel Aviv, Tel Aviv, 64239, Israel
HaEmek Medical Center
Afula, 18101, Israel
Rabin Medical Center - PPDS
Petah Tikva, 49100, Israel
Adoria
Riga, Ohio, LV-1011, Latvia
Smite Aija doctor practice in dermatology, venerology
Talsi, Talsu Aprinkis, LV-3201, Latvia
Semigallia
Kuldīga, LV-3301, Latvia
Riga 1st Hospital
Riga, LV-1001, Latvia
Health Center 4, Center of Diagnostics
Riga, LV-1003, Latvia
J. Kisis
Riga, LV-1003, Latvia
Veseliba un estetika
Riga, LV-1009, Latvia
Health Center 4, Clinic of Dermatology
Riga, LV-1013, Latvia
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, 60-101, Poland
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, 61-293, Poland
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033, Poland
Krakowskie Centrum Medyczne - FutureMeds - PPDS
Krakow, Lesser Poland Voivodeship, 31-501, Poland
WroMedica
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
Lublin, Lublin Voivodeship, 20-573, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Centrum Terapii Wspolczesnej
Lódz, Lódzkie, 90-338, Poland
ClinMedica Research
Skierniewice, Lódzkie, 96-100, Poland
ETG Siedlce - PPDS
Siedlce, Masovian Voivodeship, 08-110, Poland
RCMed Oddzial Sochaczew
Sochaczew, Masovian Voivodeship, 96-500, Poland
Clinical Research Group Sp. z o.o
Warsaw, Masovian Voivodeship, 01-142, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 02-672, Poland
ETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, 02-677, Poland
FutureMeds - Targowek - PPDS
Warsaw, Masovian Voivodeship, 03-291, Poland
MICS Centrum Medyczne Torun - MICS - PPDS
Torun, Ohio, 87-100, Poland
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Medyczne Chojnice - PRATIA - PPDS
Chojnice, Pomeranian Voivodeship, 89-600, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, 40-040, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
Pro Familia Altera Sp. z o.o.
Katowice, Silesian Voivodeship, 40-648, Poland
Centrum Uslug Medycznych MaxMed
Bochnia, 32-700, Poland
Ambulatorium Barbara Bazela
Elblag, 82-300, Poland
Globe Badania Kliniczne Spólka z o.o. - Klodzko
Klodzko Dolnoslaskie, 57-300, Poland
MCM Krakow - PRATIA - PPDS
Krakow, 30-727, Poland
Diamond Clinic
Krakow, 31-559, Poland
ETG Lublin - PPDS
Lublin, 20-314, Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.
Osielsko, 86-031, Poland
Royalderm
Warsaw, Poland
dermMEDICA Sp. z o.o
Wroclaw, 51-503, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
GCM Medical Group, PSC -62 Calle Jose Marti
San Juan, 00909-3004, Puerto Rico
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08915, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Velocity Clinical Research, High Wycombe - PPDS
High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom
4 Medical Clinical Solutions (4MCS) Swinton - PPDS
Ilford, Essex, IG1 4HP, United Kingdom
Accellacare of Yorkshire
Chorley, Lancashire, PR7 7NA, United Kingdom
Salford Royal Hospital - PPDS
Salford, Lancashire, M6 8HD, United Kingdom
Whipps Cross Hospital
London, London, City of, E11 1NR, United Kingdom
Accellacare of Northamptonshire
Harrow, Middlesex, HA1 3UJ, United Kingdom
Velocity Clinical Research, North London - PPDS
London, Middlesex, N12 8BU, United Kingdom
Accellacare - North London Clinical Studies Centre
Northwood, Middlesex, HA6 2RN, United Kingdom
St Luke's Hospital
Bradford, West Yorkshire, BD5 0NA, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
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 25, 2023
First Posted
October 31, 2023
Study Start
November 6, 2023
Primary Completion
December 6, 2024
Study Completion
November 7, 2025
Last Updated
November 20, 2025
Record last verified: 2025-11
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.