A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
NCT ID: NCT06088043
Last Updated: 2025-10-24
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
693 participants
INTERVENTIONAL
2023-11-06
2025-10-22
Brief Summary
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Detailed Description
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The study will enroll approximately 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
1. TAK-279
2. Placebo
3. Apremilast
This multi-center trial will be conducted worldwide. 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 52 weeks (1 year). 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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Saguaro Dermatology Associates, LLC - Probity - PPDS
Phoenix, Arizona, United States
First OC Dermatology - Fountain Valley
Fountain Valley, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
UCLA University of California Los Angeles
Los Angeles, California, United States
UC Davis Dermatology Clinic
Sacramento, California, United States
Driven Research LLC
Coral Gables, Florida, United States
FXM Clinical Research Ft. Lauderdale, LLC
Fort Lauderdale, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
FXM Clinical Research Miami, LLC
Miami, Florida, United States
Renstar Medical Research -21 NE 1st Ave
Ocala, Florida, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
Marietta, Georgia, United States
Leavitt Clinical Research - 1542 Elk Creek Dr
Idaho Falls, Idaho, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis, Indiana, United States
Kindred Hair & Skin Center - CAR
Columbia, Maryland, United States
Revival Research Corporation - Michigan - ClinEdge - PPDS
Troy, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Henderson Clinical Trials
Henderson, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, United States
Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS
New York, New York, United States
Accellacare of Cary
Cary, North Carolina, United States
Bexley Dermatology Research - Probity - PPDS
Bexley, Ohio, United States
Clinical Research Center of the Carolinas, LLC
Charleston, South Carolina, United States
International Clinical Research-Tennessee LLC
Murfreesboro, Tennessee, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Progressive Clinical Research PA - San Antonio
San Antonio, Texas, United States
St George Dermatology and Skin Cancer Center - Probity - PPDS
Kogarah, New South Wales, Australia
The Skin Center - Probity - PPDS
Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
Brisbane, Queensland, Australia
Skin Health Institute Inc - Probity - PPDS
Carlton, Victoria, Australia
Sinclair Dermatology-East Melbourne
East Melbourne, Victoria, Australia
Alfred Health
Parkville, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Beacon Dermatology - Probity - PPDS
Calgary, Alberta, Canada
Enverus Medical Research - Probity - PPDS
Surrey, British Columbia, Canada
CCA Medical Research - Probity - PPDS
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie, Ontario, Canada
Kingsway Clinical Research - Probity - PPDS
Etobicoke, Ontario, Canada
Guelph Dermatology Research - Probity - PPDS
Guelph, Ontario, Canada
Mediprobe Research Inc
London, Ontario, Canada
North Bay Dermatology Center - Probity - PPDS
North Bay, Ontario, Canada
North York Research Inc. - Probity - PPDS
North York, Ontario, Canada
Research Toronto - Probity - PPDS
Toronto, Ontario, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University - PPDS
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
Wenzhou, Zhejiang, China
Hautarztpraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, Germany
Klinikum Oldenburg AöR
Oldenburg (Oldenburg), Lower Saxony, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore
L’Aquila, Abruzzo, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5
Napoli, Campania, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
Genoa, Liguria, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9
Milan, Lombardy, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy
Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, Italy
Azienda Usl Toscana Centro - Firenze
Florence, Tuscany, Italy
Nagoya City University Hospital
Nagoya, Aiti, Japan
Takagi Dermatological Clinic
Obihiro-Shi, Hokkaidô, Japan
JR Sapporo Hospital
Sapporo, Hokkaidô, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaidô, Japan
Fukuoka University Hospital
Fukuoka, Hukuoka, Japan
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital
Isehara-Shi, Kanagawa, Japan
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-Ku, Tokyo, Japan
Tokyo Teishin Hospital
Sumida-Ku, Tokyo, Japan
Ohyama Dermatology Clinic
Kumamoto, , Japan
Dermatology and Ophthalmology Kume Clinic
Sakaishi, Ôsaka, Japan
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, Poland
Dermoklinika-Centrum Medyczne s.c
Lódz, Lódzkie, Poland
Rheumatology Clinic NZOZ Lecznica MAK-MED
Nadarzyn, Masovian Voivodeship, Poland
Clinical Best Solutions - Warszawa
Warsaw, Masovian Voivodeship, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDS
Warsaw, Masovian Voivodeship, Poland
High-Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, Poland
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, Poland
Klinika Ambroziak - Kosiarzy 9A
Warsaw, Masovian Voivodeship, Poland
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok, Podlaskie Voivodeship, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
Gdansk, Pomeranian Voivodeship, Poland
Derm-art
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCM - Slowackiego
Szczecin, West Pomeranian Voivodeship, Poland
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1
Lodz, , Poland
Pusan National University Hospital
Seogu, Busan Gwangyeogsi, South Korea
Chungnam National University Hospital
Daejeon, Daejeon Gwang'yeogsi, South Korea
Georgia Skin and Cancer Clinic
Savannah, Georgia, South Korea
Chosun University Hospital
Gwangju, Gwangju Gwang'yeogsi, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggido, South Korea
CHA Bundang Medical Center, CHA University - PPDS
Bundang-Gu Seongnam-Si, Gyeonggido, South Korea
Seoul National University Bundang Hospital
Bundang-Gu, Gyeonggido, South Korea
Konkuk University Medical Center
Gwangjin-Gu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Jongno-Gu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seocho-Gu, Seoul Teugbyeolsi, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi, South Korea
Ewha Womans University Seoul Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
National Taiwan University Hospital - Hsin-Chu Branch
Hsinchu, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
National Taiwan University Hospital
Zhong Zheng Qu, , Taiwan
Countries
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Related Links
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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.
Other Identifiers
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jRCT2031230583
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-505841-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-279-3001
Identifier Type: -
Identifier Source: org_study_id
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