A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
3 other identifiers
interventional
693
10 countries
132
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 61 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
132 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
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2025
CompletedOctober 24, 2025
October 1, 2025
1.2 years
October 12, 2023
October 23, 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 (PASI-75 Response) 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 (47)
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) 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 and Week 16
Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score >=2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo
Week 16
- +42 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 (132)
Saguaro Dermatology Associates, LLC - Probity - PPDS
Phoenix, Arizona, 85008-3884, United States
First OC Dermatology - Fountain Valley
Fountain Valley, California, 92708-3701, United States
Center for Dermatology Clinical Research
Fremont, California, 94538-1614, United States
UCLA University of California Los Angeles
Los Angeles, California, 90024, United States
UC Davis Dermatology Clinic
Sacramento, California, 95816-3370, United States
Driven Research LLC
Coral Gables, Florida, 33134-3901, United States
FXM Clinical Research Ft. Lauderdale, LLC
Fort Lauderdale, Florida, 33308-5211, United States
Direct Helpers Research Center
Hialeah, Florida, 33012-3618, United States
FXM Clinical Research Miami, LLC
Miami, Florida, 33175-3582, United States
Renstar Medical Research -21 NE 1st Ave
Ocala, Florida, 34470-6657, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
Marietta, Georgia, 30060-7902, United States
Leavitt Clinical Research - 1542 Elk Creek Dr
Idaho Falls, Idaho, 83404-8322, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008-3811, United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis, Indiana, 46256-4697, United States
Kindred Hair & Skin Center - CAR
Columbia, Maryland, 21046-1246, United States
Revival Research Corporation - Michigan - ClinEdge - PPDS
Troy, Michigan, 48084-3536, United States
Grekin Skin Institute
Warren, Michigan, 48088-3671, United States
Henderson Clinical Trials
Henderson, Nevada, 89052-5016, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766-1937, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, 03801-6822, United States
Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS
New York, New York, 10003-3314, United States
Accellacare of Cary
Cary, North Carolina, 27518-7414, United States
Bexley Dermatology Research - Probity - PPDS
Bexley, Ohio, 43209, United States
Clinical Research Center of the Carolinas, LLC
Charleston, South Carolina, 29407-5347, United States
International Clinical Research-Tennessee LLC
Murfreesboro, Tennessee, 37130-2450, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401-3505, United States
Progressive Clinical Research PA - San Antonio
San Antonio, Texas, 78213-2250, United States
St George Dermatology and Skin Cancer Center - Probity - PPDS
Kogarah, New South Wales, 2217, Australia
The Skin Center - Probity - PPDS
Benowa, Queensland, 4217, Australia
Veracity Clinical Research Pty Ltd
Brisbane, Queensland, 4102, Australia
Skin Health Institute Inc - Probity - PPDS
Carlton, Victoria, 3053, Australia
Sinclair Dermatology-East Melbourne
East Melbourne, Victoria, 3002, Australia
Alfred Health
Parkville, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Beacon Dermatology - Probity - PPDS
Calgary, Alberta, T3A 2N1, Canada
Enverus Medical Research - Probity - PPDS
Surrey, British Columbia, V3R 6A7, Canada
CCA Medical Research - Probity - PPDS
Ajax, Ontario, L1S 7K8, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie, Ontario, L4M 7G1, Canada
Kingsway Clinical Research - Probity - PPDS
Etobicoke, Ontario, M8X 1Y9, Canada
Guelph Dermatology Research - Probity - PPDS
Guelph, Ontario, N1H 1B1, Canada
Mediprobe Research Inc
London, Ontario, N5X 2P1, Canada
North Bay Dermatology Center - Probity - PPDS
North Bay, Ontario, P1B 3Z7, Canada
North York Research Inc. - Probity - PPDS
North York, Ontario, M2M 4J5, Canada
Research Toronto - Probity - PPDS
Toronto, Ontario, M4W 2N4, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University - PPDS
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200020, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
Wenzhou, Zhejiang, 325000, China
Hautarztpraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15831, Germany
Klinikum Oldenburg AöR
Oldenburg, Lower Saxony, 26133, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, 23562, Germany
ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore
L’Aquila, Abruzzo, 67100, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5
Napoli, Campania, 80131, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
Genoa, Liguria, 16132, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9
Milan, Lombardy, 20122, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, 20097, Italy
Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, 95123, Italy
Azienda Usl Toscana Centro - Firenze
Florence, Tuscany, 50125, Italy
Nagoya City University Hospital
Nagoya, Aiti, 467-0802, Japan
Takagi Dermatological Clinic
Obihiro-Shi, Hokkaidô, 080-0013, Japan
JR Sapporo Hospital
Sapporo, Hokkaidô, 060-0033, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaidô, 060-0063, Japan
Fukuoka University Hospital
Fukuoka, Hukuoka, 814-0180, Japan
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-ken, 892-0826, Japan
Tokai University Hospital
Isehara-Shi, Kanagawa, 259-1143, Japan
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, 329-0431, Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo, 173-0003, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-Ku, Tokyo, 169-0073, Japan
Tokyo Teishin Hospital
Sumida-Ku, Tokyo, Japan
Ohyama Dermatology Clinic
Kumamoto, 861-4101, Japan
Dermatology and Ophthalmology Kume Clinic
Sakaishi, Ôsaka, 593-8324, Japan
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566, Poland
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, 20-078, Poland
Dermoklinika-Centrum Medyczne s.c
Lódz, Lódzkie, 90-436, Poland
Rheumatology Clinic NZOZ Lecznica MAK-MED
Nadarzyn, Masovian Voivodeship, 05-830, Poland
Clinical Best Solutions - Warszawa
Warsaw, Masovian Voivodeship, 00-710, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDS
Warsaw, Masovian Voivodeship, 00-874, Poland
High-Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, 01-817, Poland
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, 02-665, Poland
Klinika Ambroziak - Kosiarzy 9A
Warsaw, Masovian Voivodeship, 02-953, Poland
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok, Podlaskie Voivodeship, 15-879, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
Gdansk, Pomeranian Voivodeship, 80-462, Poland
Derm-art
Gdynia, Pomeranian Voivodeship, 81-415, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, Silesian Voivodeship, 40-081, Poland
Twoja Przychodnia SCM - Slowackiego
Szczecin, West Pomeranian Voivodeship, 71-500, Poland
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, 85-796, Poland
Centrum Medyczne PROMED
Krakow, 31-411, Poland
Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1
Lodz, 90-647, Poland
Pusan National University Hospital
Seogu, Busan Gwangyeogsi, 49241, South Korea
Chungnam National University Hospital
Daejeon, Daejeon Gwang'yeogsi, 35015, South Korea
Georgia Skin and Cancer Clinic
Savannah, Georgia, 31419-1768, South Korea
Chosun University Hospital
Gwangju, Gwangju Gwang'yeogsi, 61453, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggido, 14647, South Korea
CHA Bundang Medical Center, CHA University - PPDS
Bundang-Gu Seongnam-Si, Gyeonggido, 13496, South Korea
Seoul National University Bundang Hospital
Bundang-Gu, Gyeonggido, 13620, South Korea
Konkuk University Medical Center
Gwangjin-Gu, Seoul Teugbyeolsi, 05030, South Korea
Seoul National University Hospital
Jongno-Gu, Seoul Teugbyeolsi, 03080, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seocho-Gu, Seoul Teugbyeolsi, 06591, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi, 04401, South Korea
Ewha Womans University Seoul Hospital
Seoul, Seoul Teugbyeolsi, 07804, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
National Taiwan University Hospital - Hsin-Chu Branch
Hsinchu, 300, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, 104, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
National Taiwan University Hospital
Zhong Zheng Qu, 100, Taiwan
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 12, 2023
First Posted
October 18, 2023
Study Start
November 6, 2023
Primary Completion
January 22, 2025
Study Completion
October 22, 2025
Last Updated
October 24, 2025
Record last verified: 2025-10
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.