A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

May 29, 2026 updated by: Takeda

A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis.

All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.

Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of 2 parts: Part A and Part B.

Part A: Participants who did not participate in one of the parent studies (TAK-279-3001 [NCT06088043], TAK-279-3002 [NCT06108544], or TAK-279-PsO-3004 [NCT06973291]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B.

Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043), TAK-279-3002 (NCT06108544), or TAK-279-PsO-3004 (NCT06973291) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2099

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad Autónomade Buenos Aires, Argentina, C1060ABN
        • Centro de Investigacion Clinica
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1012
        • CONEXA Investigacion Clinica S.A.
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Centro de Investigaciones Medicas Tucuman
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Dermatology and Skin Cancer Center - Probity - PPDS
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Center - Probity
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc - Probity - PPDS
      • Parkville, Victoria, Australia, 3050
        • Alfred Health
      • Parkville, Victoria, Australia, 3050
        • Western Health - Sunshine Hospital
  • Bulgaria
      • Gabrovo, Bulgaria
        • Multiprofile Hospital For Active Treatment Dr Tota Venkova
      • Haskovo, Bulgaria, 6300
        • Diagnostic Consultative Center Sveti
      • Pleven, Bulgaria
        • Medical Center Medconsult Pleven OOD
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Medical Center Unimed EOOD-Sevlievo
    • Kyustendil
      • Dupnitsa, Kyustendil, Bulgaria, 2600
        • Medical Center Asklepii OOD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1431
        • Diagnostic and Consulting Center Aleksandrovska EOOD
      • Sofia, Sofia-Grad, Bulgaria, 1463
        • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
      • Sofia, Sofia-Grad, Bulgaria, 1592
        • Diagnostic Consultative Center XXVIII - Sofia - EOOD
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
      • Sofia, Sofia-Grad, Bulgaria, 1510
        • Medical Center Hera EOOD-Sofia
      • Sofia, Sofia-Grad, Bulgaria, 1612
        • MC Comac Medical
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Beacon Dermatology - Probity
      • Calgary, Alberta, Canada, T3A 2N1
        • Dermatology Research Institute, Inc.
      • Edmonton, Alberta, Canada, T6H 4J8
        • VIDA Dermatology - Probity
      • Edmonton, Alberta, Canada, T6G 1C2
        • Alberta DermaSurgery Centre - Probity
      • Red Deer, Alberta, Canada, T4P 1K4
        • CaRe Clinic
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research - Probity
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Wiseman Dermatology Research Inc.
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • CCA Medical Research - Probity
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre - Probity
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research - Probity
      • Guelph, Ontario, Canada, N1L 0B7
        • Guelph Dermatology Research - Probity
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research
      • Hamilton, Ontario, Canada, L8L 3C3
        • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity
      • London, Ontario, Canada, N6H 5L5
        • DermEffects
      • London, Ontario, Canada, N5X 2P1
        • Mediprobe Research Inc
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc - Probity
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research - Probity
      • Newmarket, Ontario, Canada
        • Dr. S. K. Siddha Medicine Professional Corporation | Newmarket, Canada
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Center - Probity
      • Oakville, Ontario, Canada, L6J 7W5
        • The Centre for Clinical Trials Inc.
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Canada, M2N 3A6
        • North York Research Inc. - Probity
      • Toronto, Ontario, Canada, M3B 0A7
        • Canadian Dermatology Centre - Probity
      • Toronto, Ontario, Canada, M4W 2N4
        • Toronto Research Centre - Probity
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H3Z 2S6
        • Siena Medical Research Corporation
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Skinsense Medical Research - Probity
  • China
      • Shenzhen, China
        • The University of Hong Kong - Shenzhen Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050031
        • The First Hospital of Hebei Medical University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212001
        • Affiliated Hospital of Jiangsu University
    • Minhang District
      • Shanghai, Minhang District, China, 201100
        • Huashan Hospital Fudan University - PPDS
    • Ningxia Hui
      • Yinchuan, Ningxia Hui, China, 750004
        • General Hospital of Ningxia Medical University
    • Shan'xi
      • Xi'an, Shan'xi, China, 710004
        • The 2nd Hospital of Xi'An Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Shandong Provincial Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200020
        • Shanghai Skin Disease Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of ShanXi Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The 1st Affiliated Hospital of Wenzhou Medical University
  • Czechia
      • Prague, Czechia, 100 00
        • CLINTRIAL s.r.o.
      • Prague, Czechia, 110 00
        • Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
      • Prague, Czechia, 150 00
        • Praglandia
      • Prague, Czechia, 779 00
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové Region
      • Náchod, Hradec Králové Region, Czechia, 547 01
        • Dermamedica, s.r.o. - Kozni Ambulance Nachod
    • Moravian-Silesian Region
      • Nový Jičín, Moravian-Silesian Region, Czechia
        • Nemocnice AGEL Novy Jicin a.s
      • Ostrava, Moravian-Silesian Region, Czechia, 702 00
        • CCR Ostrava s.r.o.
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Dermskin s.r.o
    • Pardubice Region
      • Pardubice, Pardubice Region, Czechia, 530 02
        • Pratia Pardubice a.s. - PRATIA - PPDS
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Pratia Brno s.r.o. - PRATIA - PPDS
  • France
      • Rouen, France, 76031fr
        • Hopital Charles Nicolle-1 Rue de Germont
      • Saint-Etienne, France, 42270
        • Centre Hospitalier Universitaire de Saint Etienne
    • Paca
      • Martigues, Paca, France, 13500
        • Office of Mireille Ruer-Mulard, MD
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier Le Mans
  • Germany
      • Hamburg, Germany, 20354
        • Dermatologikum Hamburg
    • Brandenburg
      • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
        • Hautarztpraxis Mahlow
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Fachklinik Bad Bentheim
      • Oldenburg, Lower Saxony, Germany, 26133
        • Klinikum Oldenburg
    • Saxony
      • Dresden, Saxony, Germany, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Saxony, Germany, 01097
        • Praxis fur Dermatologie and Venerologie
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • SRH Wald-Klinikum Gera GmbH
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft.
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
    • Vas County
      • Szombathely, Vas County, Hungary
        • Markusovszky Egyetemi Oktatokorhaz
  • Israel
      • Petah Tikva, Israel
        • Rabin Medical Center - PPDS
      • Ramat Gan, Israel, 5265602
        • Chaim Sheba Medical Center
  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Presidio Ospedaliero Gaspare Rodolico
    • Tuscany
      • Florence, Tuscany, Italy, 50125
        • Azienda Usl Toscana Centro - Firenze
  • Japan
      • Kumamoto, Japan, 861-4101
        • Ohyama Dermatology Clinic
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Fukuoka
      • Fukutsu-shi, Fukuoka, Japan, 811-3217
        • Hino Dermatology Clinic
    • Hokkaidô
      • Obihiro-Shi, Hokkaidô, Japan, 080-0013
        • Takagi Dermatological Clinic
      • Sapporo, Hokkaidô, Japan, 060-0033
        • JR Sapporo Hospital
      • Sapporo, Hokkaidô, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Hukuoka
      • Fukuoka, Hukuoka, Japan, 814-0180
        • Fukuoka University Hospital
    • Osaka
      • Osaka, Osaka, Japan, 550-0006
        • Nippon Life Hospital
    • Shiga
      • Kusatsu-shi, Shiga, Japan, 525-8585
        • Seikoukai Omi Medical Center
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Sumida-Ku, Tokyo, Japan
        • Tokyo Teishin Hospital
      • Tachikawa-shi, Tokyo, Japan, 190-0023
        • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
    • Tokyo-To
      • Shinjuku-ku, Tokyo-To, Japan, 169-0073
        • JCHO Tokyo Yamate Medical Center
    • Toyama
      • Takaoka-shi, Toyama, Japan, 933-0871
        • Shirasaki Dermatology Clinic
    • Ôsaka
      • Sakaishi, Ôsaka, Japan, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
  • Latvia
      • Kuldīga, Latvia, LV-3301
        • Semigallia
      • Riga, Latvia, LV-1003
        • Aesthetic dermatology clinic of prof. J. Kisis
      • Riga, Latvia, LV-1001
        • Riga 1st Hospital
      • Riga, Latvia, LV-1009
        • Veseliba un estetika Ltd.
      • Riga, Latvia, LV-1011
        • Outpatient Clinic Adoria
      • Riga, Latvia, LV-1003
        • Health Center 4-1 Grebenscikova Str
      • Riga, Latvia, LV-1013
        • Health Center 4-Skanstes iela 50
    • Talsu Aprinkis
      • Talsi, Talsu Aprinkis, Latvia, LV-3201
        • Smite Aija medical practice in dermatology, venerology
  • Poland
      • Bochnia, Poland, 32-700
        • Centrum Uslug Medycznych MaxMed
      • Bydgoszcz, Poland, 85-796
        • Centrum Medyczne Bydgoszcz- PRATIA
      • Elblag, Poland, 82-300
        • Ambulatorium sp. z o.o.
      • Krakow, Poland, 31-411
        • Promed P. Lach R. Głowacki Sp. j., Centrum Medyczne Promed
      • Krakow, Poland, 31-559
        • Diamond Clinic Sp. z o.o., Diamond Medical Center
      • Lodz, Poland, 90-647
        • Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi, Klinika Dermatologii i Wenerologii
      • Lublin, Poland, 20-412
        • Pro Life Medica Sp. z o.o. ETG Lublin
      • Nowa Sól, Poland, 67-100
        • Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o
      • Olsztyn, Poland, 10-117
        • ETYKA Osrodek Badan Klinicznych
      • Torun, Poland, 87-100
        • MICS Centrum Medyczne Torun
      • Warsaw, Poland, 02 962
        • Royalderm Agnieszka Nawrocka
      • Wroclaw, Poland, 51-503
        • dermMEDICA Sp. z o.o. | Krzysztofa Kolumba 6
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
      • Poznan, Greater Poland Voivodeship, Poland, 61-293
        • Twoja Przychodnia PCM
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia McM Krakow
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • Centrum Medyczne All-Med
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Krakowskie Centrum Medyczne Sp. z o.o.
    • Lower Silesian Voivodeship
      • Katowice, Lower Silesian Voivodeship, Poland, 40-081
        • Centrum Medyczne Katowice - PRATIA
      • Kłodzko, Lower Silesian Voivodeship, Poland, 57-300
        • Globe Badania Kliniczne Spolka z o.o. - Klodzko
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-573
        • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
      • Lublin, Lublin Voivodeship, Poland, 20-011
        • Clinical Best Solutions Sp. z o.o. S.K.
    • Lódzkie
      • Lódz, Lódzkie, Poland, 90-338
        • Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Poland, 05-830
        • Rheumatology Clinic NZOZ Lecznica MAK-MED
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • ETG Siedlce - PPDS
      • Sochaczew, Masovian Voivodeship, Poland, 96-500
        • RCMed Oddzial Sochaczew
      • Warsaw, Masovian Voivodeship, Poland, 01-817
        • High-Med Przychodnia Specjalistyczna
      • Warsaw, Masovian Voivodeship, Poland, 01-142
        • Clinical Research Group Sp. z o.o
      • Warsaw, Masovian Voivodeship, Poland, 02-672
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Warszawa - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 03-291
        • FutureMeds - Targowek - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Masovian Voivodeship, Poland, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Masovian Voivodeship, Poland, 00-710
        • Clinical Best Solutions Sp. z o.o. S.K.
      • Warsaw, Masovian Voivodeship, Poland, 02-691
        • Klinika Reuma Park sp . zoo Sp.k.
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-879
        • ClinicMed Daniluk, Nowak Spolka Komandytowa
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych Pi-house Sp. Z O. O.
      • Gdansk, Pomeranian Voivodeship, Poland, 80-462
        • Copernicus Podmiot Leczniczy Sp. z o.o, Szpital Sw. Wojciecha, Oddzial Dermatologii
      • Gdynia, Pomeranian Voivodeship, Poland, 81-415
        • Derm-art
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Katowice, Silesian Voivodeship, Poland, 40-040
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
      • Katowice, Silesian Voivodeship, Poland, 40-611
        • Centrum Medyczne Angelius Provita
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-436
        • Dermoklinika-Centrum Medyczne s.c
      • Skierniewice, Łódź Voivodeship, Poland, 96-100
        • Velocity Skierniewice Sp. z o.o.
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
        • DERMEDIC Jacek Zdybski
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
        • Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-3004
        • GCM Medical Group
  • South Korea
      • Seoul, South Korea, 3080
        • Seoul National University Hospital
      • Seoul, South Korea
        • Chung-Ang University Hospital
      • Seoul, South Korea, 2447
        • Kyung Hee University Hospital
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 220-701
        • Yonsei University Wonju Severance Christian Hospital
    • Gwangju Gwang'yeogsi
      • Gwangju, Gwangju Gwang'yeogsi, South Korea, 61453
        • Chosun university hospital
    • Gyeonggi-do
      • Beon-gil Bundang-gu, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Gyeonggido
      • Bucheon-si, Gyeonggido, South Korea, 14647
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
    • Seoul Teugbyeolsi
      • Gwangjin-Gu, Seoul Teugbyeolsi, South Korea, 05030
        • Konkuk University Medical Center
      • Seocho-Gu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 04401
        • Soon Chun Hyang University Hospital Seoul
  • Spain
    • Guipúzcoa
      • Donostia / San Sebastian, Guipúzcoa, Spain, 20004
        • Hospital Clinico San Carlos
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital, Hsin-Chu Branch
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Mackay Memorial Hospital-Taipei branch
      • Zhong Zheng Qu, Taiwan, 100
        • National Taiwan University Hospital
    • Tainan City
      • Tainan, Tainan City, Taiwan, 70403
        • National Cheng Kung University
  • United Kingdom
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
        • Velocity Clinical Research - High Wycombe - PPDS
    • Essex
      • Ilford, Essex, United Kingdom, IG1 4HP
        • 4 Medical Clinical Solutions - Swinton - PPDS
    • Lancashire
      • Salford, Lancashire, United Kingdom, M6 8HD
        • Salford Royal Hospital - PPDS
    • London, City of
      • London, London, City of, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Accellacare of Northamptonshire
      • London, Middlesex, United Kingdom, N12 8BU
        • Velocity Clinical Research North London - Percy Road - PPDS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Dermatology
      • Birmingham, Alabama, United States, 35233-2110
        • University of Alabama Hospital - Whitaker Clinic -
      • Hoover, Alabama, United States, 35244-2111
        • Cahaba Dermatology Skin Health Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists
      • Phoenix, Arizona, United States, 85008-3884
        • Saguaro Dermatology Associates, LLC - Probity - PPDS
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916-6103
        • Johnson Dermatology Clinic
      • Hot Springs, Arkansas, United States, 71913-6475
        • Burke Pharmaceutical Research
    • California
      • Beverly Hills, California, United States, 90212
        • Zenith Research, Inc.
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology Research Inc.
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research
      • Long Beach, California, United States, 90805
        • Long Beach Research Institute
      • Los Angeles, California, United States, 90017-5310
        • Metropolis Dermatology Downtown LA - Probity - PPDS
      • Los Angeles, California, United States, 90024
        • UCLA University of California Los Angeles
      • Northridge, California, United States, 91325-4122
        • Northridge Clinical Trials
      • Sacramento, California, United States, 95816-3370
        • UC Davis Dermatology Clinic
      • San Diego, California, United States, 92123
        • University Clinical Trials
      • San Diego, California, United States, 92123-1523
        • TCR Medical Corporation
      • Santa Monica, California, United States, 90404-2216
        • Dermatology Institute and Skin Care Center
      • Sherman Oaks, California, United States, 91403
        • UNISON Clinical Trials (Shahram Jacobs md inc.)
    • Florida
      • Coral Gables, Florida, United States, 33134-3901
        • Driven Research LLC
      • Doral, Florida, United States, 33122-1902
        • Revival Research Corporation - Florida - ClinEdge - PPDS
      • Fort Lauderdale, Florida, United States, 33308-5211
        • FXM Clinical Research Ft. Lauderdale, LLC
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Medical Center
      • Miami, Florida, United States, 33136-1003
        • Florida Academic Centers Research
      • Miami, Florida, United States, 33175-3582
        • FXM Clinical Research Miami, LLC
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic Inc
      • Miramar, Florida, United States, 33027-4714
        • FXM Research Miramar
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research -21 NE 1st Ave
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group
      • Tampa, Florida, United States, 33607-6429
        • Advanced Clinical Research Institute (ACRI) - Florida
    • Georgia
      • Atlanta, Georgia, United States, 30315-2042
        • Divine Dermatology and Aesthetics, LLC
      • Marietta, Georgia, United States, 30060-7902
        • Marietta Dermatology & The Skin Cancer Center - Marietta
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research, PC
      • Savannah, Georgia, United States, 31419-1768
        • Georgia Skin and Cancer Clinic
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-8322
        • Leavitt Clinical Research
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008-3811
        • Arlington Dermatology
      • Skokie, Illinois, United States, 60077-1049
        • NorthShore Medical Group Dermatology - Skokie
    • Indiana
      • Clarksville, Indiana, United States, 47129-2201
        • DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40217-1444
        • Skin Sciences, PLLC
      • Louisville, Kentucky, United States, 40241-6162
        • Dermatology Specialists Research - 3810 Springhurst Blvd
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J Green, MD LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5360
        • University of Michigan Hospital - 1500 E Medical Center Dr
      • Auburn Hills, Michigan, United States, 48326-3396
        • Oakland Hills Dermatology - 3400 Auburn Rd
      • Troy, Michigan, United States, 48084-3536
        • Revival Research Corporation - ClinEdge
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists PC
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Henderson Clinical Trials
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766-1937
        • Dartmouth Hitchcock Medical Center - Old Etna Rd
      • Portsmouth, New Hampshire, United States, 03801
        • ALLCUTIS Research, LLC.
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • New York
      • New York, New York, United States, 10075-0385
        • Sadick Research Group
      • The Bronx, New York, United States, 10467
        • Montefiore AOA - BRANY
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Accellacare of Cary
      • Winston-Salem, North Carolina, United States, 27103-7109
        • The Skin Surgery Center for Clinical Research - Objective Health - PPDS
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research - Probity - PPDS
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
      • Mayfield Heights, Ohio, United States, 44124-4005
        • Apex Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Medical Research Center PC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • University of Pittsburgh Medical Center-3601 5th Ave
    • Tennessee
      • Hermitage, Tennessee, United States, 37076-3497
        • Cumberland Skin Center for Clinical Research - Objective Health - PPDS
      • Murfreesboro, Tennessee, United States, 37130-2450
        • International Clinical Research US LLC
    • Texas
      • Arlington, Texas, United States, 76011-3800
        • Arlington Research Center
      • Bellaire, Texas, United States, 77401-3505
        • Bellaire Dermatology Associates
      • Bellaire, Texas, United States, 77401
        • UT Physicians Dermatology - Bellaire Station
      • Dallas, Texas, United States, 75231-6077
        • Modern Research Associates
      • Frisco, Texas, United States, 75034
        • North Texas Center for Clinical Research
      • San Antonio, Texas, United States, 78229-3409
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, United States, 78213-2250
        • San Antonio
      • San Antonio, Texas, United States, 78218-3128
        • Texas Dermatology and Laser Specialists-San Antonio-7703 Floyd Curl Dr
      • Sugar Land, Texas, United States, 77479-1001
        • Houston Center for Clinical Research, LLC
      • Webster, Texas, United States, 77598-4927
        • Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research - 6160 Kempsville Cir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

Part A:

  • Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
  • Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures.
  • Participant is aged 18 years or older at the time of consent.
  • Participant has a diagnosis of chronic plaque psoriasis for >=6 months prior to the screening visit.
  • Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening.
  • Participant has moderate-to-severe plaque psoriasis as defined by a PASI score >=12 and a sPGA score >=3 at screening and Day 1.
  • Participant has plaque psoriasis covering >=10% of his or her total BSA at screening and Day 1.
  • Participant must be a candidate for phototherapy or systemic therapy.

Part B:

- Participant has completed 52 weeks of treatment (TAK-279-3001 or Part A) or 60 weeks of treatment (TAK-279-3002), or 16 weeks of treatment (TAK-279-PsO-3004) in their parent study.

Main Exclusion Criteria

Part A:

  • Participant has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
  • Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (e.g., inflammatory bowel disease).

  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. These include but are not limited to:

    1. Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
    2. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
    3. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
    4. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
    5. Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
    6. For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
    7. Participant has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (e.g., pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
    8. Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the investigator.
    9. Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
    10. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
    11. Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
    12. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.

  • Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:

    1. Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
    2. Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1.
    3. Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
    4. Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1.
  • Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor.
  • Participant has a known or suspected allergy to TAK-279 or any of its components.

Part B:

  • Participant has completed the parent study or Part A but was permanently discontinued from treatment.
  • Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator.
  • Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A.
  • Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A.
  • Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279

Part A: Participants will receive TAK-279, oral tablet once daily (QD) for up to 52 weeks.

Part B: Participants who completed the treatment period of parent studies (TAK-279-3001 [NCT06088043], TAK-279-3002 [NCT06108544], or TAK-279-PsO-3004 [NCT06973291]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.
Drug: TAK-279
TAK-279 oral tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
Time Frame: From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.
From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score
Time Frame: Baseline up to Week 52 (Part A) and Week 156 (Part B)
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. The PASI-75 is defined as 75% improvement from baseline in PASI score.
Baseline up to Week 52 (Part A) and Week 156 (Part B)
Part A and B: Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a >=2-point Decrease from Baseline
Time Frame: Baseline up to Week 52 (Part A) and Week 156 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean greater than or equal to (>=) 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5.
Baseline up to Week 52 (Part A) and Week 156 (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-279-PsO-3003
  • 2024-512496-12-00 (Ctis)
  • jRCT2031240413 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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