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
NCT ID: NCT06108544
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1108 participants
INTERVENTIONAL
2023-11-06
2025-11-07
Brief Summary
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Detailed Description
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The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):
* TAK-279
* Apremilast
* Placebo
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAK-279
TAK-279
Specified drug on specified days.
Placebo
Placebo
Specified drug on specified days.
Apremilast
Apremilast
Specified drug on specified days.
Interventions
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TAK-279
Specified drug on specified days.
Placebo
Specified drug on specified days.
Apremilast
Specified drug on specified days.
Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.
Exclusion Criteria
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Total Dermatology
Birmingham, Alabama, United States
Cahaba Dermatology Skin Health Center
Hoover, Alabama, United States
Medical Dermatology Specialists
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Zenith Research, Inc.
Beverly Hills, California, United States
UNISON Clinical Trials (Shahram Jacobs md inc.)
Encino, California, United States
First OC Dermatology Research Inc.
Fountain Valley, California, United States
Long Beach Research Institute, LLC
Long Beach, California, United States
Metropolis Dermatology Downtown LA - Probity - PPDS
Los Angeles, California, United States
Northridge Clinical Trials
Northridge, California, United States
TCR Medical Corporation
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Dermatology Institute and Skin Care Center
Santa Monica, California, United States
Revival Research Corporation - Florida - ClinEdge - PPDS
Doral, Florida, United States
Florida Academic Centers Research
Miami, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States
Olympian Clinical Research - 6331 Memorial Hwy
Tampa, Florida, United States
Divine Dermatology and Aesthetics, LLC
Atlanta, Georgia, United States
Advanced Medical Research, PC
Atlanta, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, United States
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
DS Research of Kentucky
Louisville, Kentucky, United States
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, United States
Lawrence J Green, MD LLC
Rockville, Maryland, United States
Allcutis Research LLC
Beverly, Massachusetts, United States
Beacon Clinical Research LLC
Brockton, Massachusetts, United States
David Fivenson MD Dermatology PLLC
Ann Arbor, Michigan, United States
University of Michigan Hospital - 1500 E Medical Center Dr
Ann Arbor, Michigan, United States
Oakland Hills Dermatology - 3400 Auburn Rd
Auburn Hills, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Specialists PC
Omaha, Nebraska, United States
Vivida Dermatology - Flamingo Rd - Probity - PPDS
Las Vegas, Nevada, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Mount Sinai Doctors -234 E 85th St
New York, New York, United States
Sadick Research Group
New York, New York, United States
Derm Research Center of NY
Stony Brook, New York, United States
Montefiore Dermatology - BRANY - PPDS
The Bronx, New York, United States
Duke Dermatology Clinic
Durham, North Carolina, United States
The Skin Surgery Center for Clinical Research - Objective Health - PPDS
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health Department of Dermatology - 4618 Country Club Rd
Winston-Salem, North Carolina, United States
ClinOhio Research Services
Columbus, Ohio, United States
Wright State Physicians
Fairborn, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Oregon Medical Research Center PC
Portland, Oregon, United States
University of Pittsburgh Medical Center-3601 5th Ave
Pittsburgh, Pennsylvania, United States
Cumberland Skin Center for Clinical Research - Objective Health - PPDS
Hermitage, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Arlington Research Center
Arlington, Texas, United States
UT Physicians Dermatology - Bellaire Station
Bellaire, Texas, United States
Modern Research Associates
Dallas, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Houston Center for Clinical Research, LLC
Sugar Land, Texas, United States
Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
Webster, Texas, United States
Center For Clinical Studies,LTD. LLP - 451 N Texas Ave
Webster, Texas, United States
Virginia Clinical Research - 6160 Kempsville Cir
Norfolk, Virginia, United States
Conexa Investigación Clínica S.A.
Buenos Aires, , Argentina
STAT Research S.A.
Buenos Aires, , Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, , Argentina
Centro de Investigacion Clínica - CEDIC
Ciudad Autónomade Buenos Aires, , Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, , Argentina
Medical Center Unimed EOOD
Sevlievo, Gabrovo, Bulgaria
Medical Center Asklepii OOD
Dupnitsa, Kyustendil, Bulgaria
MBAL Skin Systems, Doganovo
Elin Pelin, Sofia, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Sofia-Grad, Bulgaria
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Sofia-Grad, Bulgaria
Medical Center Hera EOOD
Sofia, Sofia-Grad, Bulgaria
Diagnostic Consultative Center XXVIII - Sofia - EOOD
Sofia, Sofia-Grad, Bulgaria
Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD
Sofia, Sofia-Grad, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, Bulgaria
MC Comac Medical - IRN - PPDS
Sofia, Sofia-Grad, Bulgaria
Multiprofile Hospital for Active Treatment - Dobrich AD
Dobrich, , Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, , Bulgaria
Diagnostic Consultative Center Sveti Georgi EOOD
Haskovo, , Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
Medical Center Exacta Medica - Vasil Levski 60
Pleven, , 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, Canada
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, Canada
VIDA Dermatology - Probity - PPDS
Edmonton, Alberta, Canada
CaRe Clinic-Red Deer
Red Deer, Alberta, Canada
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, Canada
Brunswick Dermatology Centre - Probity - PPDS
Fredericton, New Brunswick, Canada
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
Hamilton, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
DermEffects - Probity - PPDS
London, Ontario, Canada
Lynderm Research Inc - Probity - PPDS
Markham, Ontario, Canada
DermEdge Research - Probity - PPDS
Mississauga, Ontario, Canada
The Centre for Clinical Trials Inc. - Probity - PPDS
Oakville, Ontario, Canada
Oshawa Clinic-117 King St
Oshawa, Ontario, Canada
SKiN Centre for Dermatology - Peterborough - Probity - PPDS
Peterborough, Ontario, Canada
Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
Richmond Hill, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
Richmond Hill, Ontario, Canada
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, Canada
Toronto Research Centre - Probity - PPDS
Toronto, Ontario, Canada
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, Canada
XLR8 Medical Research - Probity - PPDS
Windsor, Ontario, Canada
Siena Medical Research
Westmount, Quebec, Canada
Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS
Saskatoon, Saskatchewan, Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, China
Huashan Hospital Fudan University - PPDS
Shanghai, , China
Dermamedica, s.r.o. - Kozni Ambulance Nachod
Náchod, Královéhradecký kraj, Czechia
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezský kraj, Czechia
CCR Ostrava s.r.o.
Ostrava, Moravskoslezský kraj, Czechia
Praglandia s.r.o.
Prague, Ohio, Czechia
Dermskin s.r.o.
Olomouc, Olomoucký kraj, Czechia
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto, Czechia
Pratia Brno s.r.o. - PRATIA - PPDS
Brno, South Moravian, Czechia
Pratia Pardubice a.s. - PRATIA - PPDS
Pardubice, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
Prague, , Czechia
Centre Hospitalier Le Mans
Le Mans, Ohio, France
AP-HM- Hôpital de La Timone
Marseille, , France
Hôpital Charles Nicolle-1 Rue de Germont
Rouen, , France
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Klinische Forschung Dresden GmbH (KFGN) - PRATIA - PPDS
Dresden, Saxony, Germany
Praxis fur Dermatologie and Venerologie
Dresden, Saxony, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, Germany
FutureMeds - Berlin - PPDS
Berlin, , Germany
Dermatologikum Hamburg
Hamburg, , Germany
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, , Germany
Hospital A.Syggros
Athens, Attica, Greece
University General Hospital ''ATTIKON''
Chaïdári, Attica, Greece
University Hospital of Ioannina
Loannina, Loannina, Greece
Hospital Of Skin And Venereal Diseases of Thessaloniki
Thessaloniki, , Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, , Greece
Szegedi Tudomanyegyetem
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, Hungary
Allergo-Derm Bakos Kft- Szolnok-Baross utca 20
Szolnok, Jász-Nagykun-Szolnok, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, Somogy County, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Szombathely, Vas County, Hungary
Pécsi Tudomanyegyetem - Vasvari Pal u.
Pécs, , Hungary
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS 27004
Tel Aviv, Tel Aviv, Israel
HaEmek Medical Center
Afula, , Israel
Rabin Medical Center - PPDS
Petah Tikva, , Israel
Adoria
Riga, Ohio, Latvia
Smite Aija doctor practice in dermatology, venerology
Talsi, Talsu Aprinkis, Latvia
Semigallia
Kuldīga, , Latvia
Riga 1st Hospital
Riga, , Latvia
Health Center 4, Center of Diagnostics
Riga, , Latvia
J. Kisis
Riga, , Latvia
Veseliba un estetika
Riga, , Latvia
Health Center 4, Clinic of Dermatology
Riga, , Latvia
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, Poland
Krakowskie Centrum Medyczne - FutureMeds - PPDS
Krakow, Lesser Poland Voivodeship, Poland
WroMedica
Wroclaw, Lower Silesian Voivodeship, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
Lublin, Lublin Voivodeship, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, Poland
Centrum Terapii Wspolczesnej
Lódz, Lódzkie, Poland
ClinMedica Research
Skierniewice, Lódzkie, Poland
ETG Siedlce - PPDS
Siedlce, Masovian Voivodeship, Poland
RCMed Oddzial Sochaczew
Sochaczew, Masovian Voivodeship, Poland
Clinical Research Group Sp. z o.o
Warsaw, Masovian Voivodeship, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, Poland
ETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, Poland
FutureMeds - Targowek - PPDS
Warsaw, Masovian Voivodeship, Poland
MICS Centrum Medyczne Torun - MICS - PPDS
Torun, Ohio, Poland
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Chojnice - PRATIA - PPDS
Chojnice, Pomeranian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Pro Familia Altera Sp. z o.o.
Katowice, Silesian Voivodeship, Poland
Centrum Uslug Medycznych MaxMed
Bochnia, , Poland
Ambulatorium Barbara Bazela
Elblag, , Poland
Globe Badania Kliniczne Spólka z o.o. - Klodzko
Klodzko Dolnoslaskie, , Poland
MCM Krakow - PRATIA - PPDS
Krakow, , Poland
Diamond Clinic
Krakow, , Poland
ETG Lublin - PPDS
Lublin, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.
Osielsko, , Poland
Royalderm
Warsaw, , Poland
dermMEDICA Sp. z o.o
Wroclaw, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
GCM Medical Group, PSC -62 Calle Jose Marti
San Juan, , Puerto Rico
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Velocity Clinical Research, High Wycombe - PPDS
High Wycombe, Buckinghamshire, United Kingdom
4 Medical Clinical Solutions (4MCS) Swinton - PPDS
Ilford, Essex, United Kingdom
Accellacare of Yorkshire
Chorley, Lancashire, United Kingdom
Salford Royal Hospital - PPDS
Salford, Lancashire, United Kingdom
Whipps Cross Hospital
London, London, City of, United Kingdom
Accellacare of Northamptonshire
Harrow, Middlesex, United Kingdom
Velocity Clinical Research, North London - PPDS
London, Middlesex, United Kingdom
Accellacare - North London Clinical Studies Centre
Northwood, Middlesex, United Kingdom
St Luke's Hospital
Bradford, West Yorkshire, United Kingdom
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2023-505842-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-279-3002
Identifier Type: -
Identifier Source: org_study_id
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