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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-10-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAK-279

Group Type EXPERIMENTAL

TAK-279

Intervention Type DRUG

Specified drug on specified days.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified drug on specified days.

Apremilast

Group Type ACTIVE_COMPARATOR

Apremilast

Intervention Type DRUG

Specified drug on specified days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAK-279

Specified drug on specified days.

Intervention Type DRUG

Placebo

Specified drug on specified days.

Intervention Type DRUG

Apremilast

Specified drug on specified days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.

Exclusion Criteria

1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saguaro Dermatology Associates, LLC - Probity - PPDS

Phoenix, Arizona, United States

Site Status

First OC Dermatology - Fountain Valley

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research

Fremont, California, United States

Site Status

UCLA University of California Los Angeles

Los Angeles, California, United States

Site Status

UC Davis Dermatology Clinic

Sacramento, California, United States

Site Status

Driven Research LLC

Coral Gables, Florida, United States

Site Status

FXM Clinical Research Ft. Lauderdale, LLC

Fort Lauderdale, Florida, United States

Site Status

Direct Helpers Research Center

Hialeah, Florida, United States

Site Status

FXM Clinical Research Miami, LLC

Miami, Florida, United States

Site Status

Renstar Medical Research -21 NE 1st Ave

Ocala, Florida, United States

Site Status

Marietta Dermatology & The Skin Cancer Center - Marietta

Marietta, Georgia, United States

Site Status

Leavitt Clinical Research - 1542 Elk Creek Dr

Idaho Falls, Idaho, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave

Indianapolis, Indiana, United States

Site Status

Kindred Hair & Skin Center - CAR

Columbia, Maryland, United States

Site Status

Revival Research Corporation - Michigan - ClinEdge - PPDS

Troy, Michigan, United States

Site Status

Grekin Skin Institute

Warren, Michigan, United States

Site Status

Henderson Clinical Trials

Henderson, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, United States

Site Status

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

New York, New York, United States

Site Status

Accellacare of Cary

Cary, North Carolina, United States

Site Status

Bexley Dermatology Research - Probity - PPDS

Bexley, Ohio, United States

Site Status

Clinical Research Center of the Carolinas, LLC

Charleston, South Carolina, United States

Site Status

International Clinical Research-Tennessee LLC

Murfreesboro, Tennessee, United States

Site Status

Bellaire Dermatology Associates

Bellaire, Texas, United States

Site Status

Progressive Clinical Research PA - San Antonio

San Antonio, Texas, United States

Site Status

St George Dermatology and Skin Cancer Center - Probity - PPDS

Kogarah, New South Wales, Australia

Site Status

The Skin Center - Probity - PPDS

Benowa, Queensland, Australia

Site Status

Veracity Clinical Research Pty Ltd

Brisbane, Queensland, Australia

Site Status

Skin Health Institute Inc - Probity - PPDS

Carlton, Victoria, Australia

Site Status

Sinclair Dermatology-East Melbourne

East Melbourne, Victoria, Australia

Site Status

Alfred Health

Parkville, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Beacon Dermatology - Probity - PPDS

Calgary, Alberta, Canada

Site Status

Enverus Medical Research - Probity - PPDS

Surrey, British Columbia, Canada

Site Status

CCA Medical Research - Probity - PPDS

Ajax, Ontario, Canada

Site Status

SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS

Barrie, Ontario, Canada

Site Status

Kingsway Clinical Research - Probity - PPDS

Etobicoke, Ontario, Canada

Site Status

Guelph Dermatology Research - Probity - PPDS

Guelph, Ontario, Canada

Site Status

Mediprobe Research Inc

London, Ontario, Canada

Site Status

North Bay Dermatology Center - Probity - PPDS

North Bay, Ontario, Canada

Site Status

North York Research Inc. - Probity - PPDS

North York, Ontario, Canada

Site Status

Research Toronto - Probity - PPDS

Toronto, Ontario, Canada

Site Status

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital Medical University - PPDS

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Site Status

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status

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

Wenzhou, Zhejiang, China

Site Status

Hautarztpraxis Mahlow

Blankenfelde-Mahlow, Brandenburg, Germany

Site Status

Klinikum Oldenburg AöR

Oldenburg (Oldenburg), Lower Saxony, Germany

Site Status

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status

ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore

L’Aquila, Abruzzo, Italy

Site Status

Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5

Napoli, Campania, Italy

Site Status

IRCCS Az. Osp. Universitaria San Martino- IST

Genoa, Liguria, Italy

Site Status

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9

Milan, Lombardy, Italy

Site Status

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Site Status

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, Italy

Site Status

Presidio Ospedaliero Gaspare Rodolico

Catania, Sicily, Italy

Site Status

Azienda Usl Toscana Centro - Firenze

Florence, Tuscany, Italy

Site Status

Nagoya City University Hospital

Nagoya, Aiti, Japan

Site Status

Takagi Dermatological Clinic

Obihiro-Shi, Hokkaidô, Japan

Site Status

JR Sapporo Hospital

Sapporo, Hokkaidô, Japan

Site Status

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hokkaidô, Japan

Site Status

Fukuoka University Hospital

Fukuoka, Hukuoka, Japan

Site Status

Saruwatari Dermatology Clinic

Kagoshima, Kagoshima-ken, Japan

Site Status

Tokai University Hospital

Isehara-Shi, Kanagawa, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke-Shi, Tochigi, Japan

Site Status

Teikyo University Hospital

Itabashi-Ku, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Site Status

JCHO Tokyo Yamate Medical Center

Shinjuku-Ku, Tokyo, Japan

Site Status

Tokyo Teishin Hospital

Sumida-Ku, Tokyo, Japan

Site Status

Ohyama Dermatology Clinic

Kumamoto, , Japan

Site Status

Dermatology and Ophthalmology Kume Clinic

Sakaishi, Ôsaka, Japan

Site Status

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

Poznan, Greater Poland Voivodeship, Poland

Site Status

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship, Poland

Site Status

Dermoklinika-Centrum Medyczne s.c

Lódz, Lódzkie, Poland

Site Status

Rheumatology Clinic NZOZ Lecznica MAK-MED

Nadarzyn, Masovian Voivodeship, Poland

Site Status

Clinical Best Solutions - Warszawa

Warsaw, Masovian Voivodeship, Poland

Site Status

MICS Centrum Medyczne Warszawa - MICS - PPDS

Warsaw, Masovian Voivodeship, Poland

Site Status

High-Med Przychodnia Specjalistyczna

Warsaw, Masovian Voivodeship, Poland

Site Status

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, Masovian Voivodeship, Poland

Site Status

Klinika Ambroziak - Kosiarzy 9A

Warsaw, Masovian Voivodeship, Poland

Site Status

ClinicMed Daniluk, Nowak Spólka Komandytowa

Bialystok, Podlaskie Voivodeship, Poland

Site Status

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Derm-art

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice, Silesian Voivodeship, Poland

Site Status

Twoja Przychodnia SCM - Slowackiego

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Bydgoszcz- PRATIA - PPDS

Bydgoszcz, , Poland

Site Status

Centrum Medyczne PROMED

Krakow, , Poland

Site Status

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

Lodz, , Poland

Site Status

Pusan National University Hospital

Seogu, Busan Gwangyeogsi, South Korea

Site Status

Chungnam National University Hospital

Daejeon, Daejeon Gwang'yeogsi, South Korea

Site Status

Georgia Skin and Cancer Clinic

Savannah, Georgia, South Korea

Site Status

Chosun University Hospital

Gwangju, Gwangju Gwang'yeogsi, South Korea

Site Status

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

Bucheon-si, Gyeonggido, South Korea

Site Status

CHA Bundang Medical Center, CHA University - PPDS

Bundang-Gu Seongnam-Si, Gyeonggido, South Korea

Site Status

Seoul National University Bundang Hospital

Bundang-Gu, Gyeonggido, South Korea

Site Status

Konkuk University Medical Center

Gwangjin-Gu, Seoul Teugbyeolsi, South Korea

Site Status

Seoul National University Hospital

Jongno-Gu, Seoul Teugbyeolsi, South Korea

Site Status

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

Seocho-Gu, Seoul Teugbyeolsi, South Korea

Site Status

Soon Chun Hyang University Hospital Seoul

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Ewha Womans University Seoul Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

National Taiwan University Hospital - Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Mackay Memorial Hospital-Taipei branch

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Site Status

National Taiwan University Hospital

Zhong Zheng Qu, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada China Germany Italy Japan Poland South Korea Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.takeda.com/study-detail/c67dd5b3d0534f80

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

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Apremilast in Palmo-Plantar Psoriasis
NCT02400749 COMPLETED PHASE4