A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

Last updated: October 15, 2024
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Scalp Disorders

Rash

Treatment

Placebo

Apremilast

TAK-279

Clinical Study ID

NCT06088043
TAK-279-3001
2023-505841-22
jRCT2031230583
2023-505841-22-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Plaque psoriasis for at least 6 months.

  2. Moderate to severe disease.

  3. Candidate for phototherapy or systemic therapy.

Exclusion

Exclusion Criteria:

  1. Other forms of psoriasis.

  2. History of recent infection.

  3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 693
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 06, 2023
Estimated Completion Date:
April 15, 2026

Study Description

The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.

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.

Connect with a study center

  • St George Dermatology and Skin Cancer Center - Probity - PPDS

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • The Skin Center - Probity - PPDS

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Skin Health Institute Inc - Probity - PPDS

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Sinclair Dermatology-East Melbourne

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Alfred Health

    Parkville, Victoria 3004
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Beacon Dermatology - Probity - PPDS

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Enverus Medical Research - Probity - PPDS

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • CCA Medical Research - Probity - PPDS

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Kingsway Clinical Research - Probity - PPDS

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Guelph Dermatology Research - Probity - PPDS

    Guelph, Ontario N1H 1B1
    Canada

    Site Not Available

  • Mediprobe Research Inc

    London, Ontario N5X 2P1
    Canada

    Site Not Available

  • North Bay Dermatology Center - Probity - PPDS

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • North York Research Inc. - Probity - PPDS

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Research Toronto - Probity - PPDS

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University - PPDS

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong 518053
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050031
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shaanxi 710004
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai 200020
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Hautarztpraxis Mahlow

    Blankenfelde-Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Klinikum Oldenburg AöR

    Oldenburg (Oldenburg), Niedersachsen 26133
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Schleswig-Holstein 23562
    Germany

    Site Not Available

  • ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore

    L'aquila, Abruzzo 67100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5

    Napoli, Campania 80131
    Italy

    Site Not Available

  • IRCCS Az. Osp. Universitaria San Martino- IST

    Genova, Liguria 16132
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    San Donato Milanese, Lombardia 20097
    Italy

    Site Not Available

  • Presidio Ospedaliero Gaspare Rodolico

    Catania, Sicilia 95123
    Italy

    Site Not Available

  • Azienda Usl Toscana Centro - Firenze

    Firenze, Toscana 50125
    Italy

    Site Not Available

  • Nagoya City University Hospital

    Nagoya-Shi, Aiti 467-0802
    Japan

    Site Not Available

  • Takagi Dermatological Clinic

    Obihiro-Shi, Hokkaidô 080-0013
    Japan

    Site Not Available

  • JR Sapporo Hospital

    Sapporo-Shi, Hokkaidô 060-0033
    Japan

    Site Not Available

  • Medical Corporation Kojinkai Sapporo Skin Clinic

    Sapporo-Shi, Hokkaidô 060-0063
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-Shi, Hukuoka 814-0180
    Japan

    Site Not Available

  • Saruwatari Dermatology Clinic

    Kagoshima-Shi, Kagosima 892-0826
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara-Shi, Kanagawa 259-1143
    Japan

    Site Not Available

  • Teikyo University Hospital

    Itabashi-Ku, Tokyo 173-0003
    Japan

    Site Not Available

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-Ku, Tokyo 169-0073
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Tokyo Teishin Hospital

    Sumida-Ku, Tokyo
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke-Shi, Totigi 329-0431
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai-Shi, Ôsaka 593-8324
    Japan

    Site Not Available

  • Ohyama Dermatology Clinic

    Kumamoto, 861-4101
    Japan

    Site Not Available

  • Pusan National University Hospital

    Seo-Gu, Busan Gwangyeogsi 49241
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, Daejeon Gwang'yeogsi 35015
    Korea, Republic of

    Site Not Available

  • Georgia Skin and Cancer Clinic

    Savannah, Georgia 31419-1768
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju, Gwangju Gwang'yeogsi 61453
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggido 14647
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University - PPDS

    Bundang, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Bundang-Gu, Gyeonggido 13620
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University - PPDS

    Bundang-Gu Seongnam-Si, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Gwangjin, Seoul Teugbyeolsi 05030
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Gwangjin-Gu, Seoul Teugbyeolsi 05030
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno-Gu, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seocho, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seocho-Gu, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Seoul Hospital

    Seoul, Seoul Teugbyeolsi 07804
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Seoul

    Seoul, Seoul Teugbyeolsi 04401
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, 26426
    Korea, Republic of

    Site Not Available

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Dolnoslaskie 50-566
    Poland

    Site Not Available

  • Clinical Best Solutions - Lublin

    Lublin, Lubelskie 20-078
    Poland

    Site Not Available

  • Dermoklinika-Centrum Medyczne s.c

    Lódz, Lódzkie 90-436
    Poland

    Site Not Available

  • Rheumatology Clinic NZOZ Lecznica MAK-MED

    Nadarzyn, Mazowieckie 05-830
    Poland

    Site Not Available

  • Klinika Ambroziak - Kosiarzy 9A

    Warsaw, Mazowieckie 02-953
    Poland

    Site Not Available

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Mazowieckie 02-665
    Poland

    Site Not Available

  • Clinical Best Solutions - Warszawa

    Warszawa, Mazowieckie 00-710
    Poland

    Site Not Available

  • High-Med Przychodnia Specjalistyczna

    Warszawa, Mazowieckie 01-817
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia - ul. Kosiarzy 9A

    Warszawa, Mazowieckie 02-008
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warszawa, Mazowieckie 00-874
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa - MICS - PPDS

    Warszawa, Mazowieckie 00-874
    Poland

    Site Not Available

  • ClinicMed Daniluk, Nowak Spólka Komandytowa

    Bialystok, Podlaskie 15-879
    Poland

    Site Not Available

  • Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50

    Gdansk, Pomorskie 80-462
    Poland

    Site Not Available

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdańsk, Pomorskie 80-382
    Poland

    Site Not Available

  • Derm-art

    Gdynia, Pomorskie 81-415
    Poland

    Site Not Available

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, Slaskie 40-081
    Poland

    Site Not Available

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznań, Wielkopolskie 60-702
    Poland

    Site Not Available

  • Twoja Przychodnia SCM - Slowackiego

    Szczecin, Zachodniopomorskie 71-500
    Poland

    Site Not Available

  • Centrum Medyczne Bydgoszcz- PRATIA - PPDS

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • Centrum Medyczne PROMED

    Krakow, 31-411
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1

    Lodz, 90-647
    Poland

    Site Not Available

  • National Taiwan University Hospital - Hsin-Chu Branch

    Hsinchu, 300
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital-Taipei branch

    Taipei, 104
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei City, 11217
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Zhong Zheng Qu, 100
    Taiwan

    Site Not Available

  • Saguaro Dermatology Associates, LLC - Probity - PPDS

    Phoenix, Arizona 85008-3884
    United States

    Site Not Available

  • First OC Dermatology - Fountain Valley

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • Center for Dermatology Clinical Research

    Fremont, California 94538-1614
    United States

    Site Not Available

  • UCLA University of California Los Angeles

    Los Angeles, California 90024
    United States

    Site Not Available

  • UC Davis Dermatology Clinic

    Sacramento, California 95816-3370
    United States

    Site Not Available

  • Driven Research LLC

    Coral Gables, Florida 33134-3901
    United States

    Site Not Available

  • FXM Clinical Research Ft. Lauderdale, LLC

    Fort Lauderdale, Florida 33308-5211
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012-3618
    United States

    Site Not Available

  • FXM Clinical Research Miami, LLC

    Miami, Florida 33175-3582
    United States

    Site Not Available

  • Renstar Medical Research -21 NE 1st Ave

    Ocala, Florida 34470-6657
    United States

    Site Not Available

  • Marietta Dermatology & The Skin Cancer Center - Marietta

    Marietta, Georgia 30060-7902
    United States

    Site Not Available

  • Georgia Skin and Cancer Clinic

    Savannah, Georgia 31419-1768
    United States

    Active - Recruiting

  • Leavitt Clinical Research

    Idaho Falls, Idaho 83404-8322
    United States

    Active - Recruiting

  • Leavitt Clinical Research - 1542 Elk Creek Dr

    Idaho Falls, Idaho 83404-8322
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008-3811
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana 46256-4697
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave

    Indianapolis, Indiana 46256-4697
    United States

    Site Not Available

  • Kindred Hair & Skin Center - CAR

    Columbia, Maryland 21046-1246
    United States

    Site Not Available

  • Revival Research Corporation - Michigan - ClinEdge - PPDS

    Troy, Michigan 48084-3536
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088-3671
    United States

    Site Not Available

  • Henderson Clinical Trials

    Henderson, Nevada 89052-5016
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03766-1937
    United States

    Site Not Available

  • ALLCUTIS Research, LLC.

    Portsmouth, New Hampshire 03801-6822
    United States

    Site Not Available

  • Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS

    New York, New York 10003-3314
    United States

    Site Not Available

  • Accellacare of Cary

    Cary, North Carolina 27518-7414
    United States

    Site Not Available

  • Bexley Dermatology Research - Probity - PPDS

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Clinical Research Center of the Carolinas, LLC

    Charleston, South Carolina 29407-5347
    United States

    Site Not Available

  • International Clinical Research-Tennessee LLC

    Murfreesboro, Tennessee 37130-2450
    United States

    Site Not Available

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401-3505
    United States

    Site Not Available

  • Progressive Clinical Research PA - San Antonio

    San Antonio, Texas 78213-2250
    United States

    Site Not Available

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