A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

NCT ID: NCT06108544

Last Updated: 2025-11-20

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-11-07

Brief Summary

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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 69 weeks.

Detailed Description

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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 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):

* TAK-279
* Apremilast
* Placebo

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. 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 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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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

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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

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Total Dermatology

Birmingham, Alabama, United States

Site Status

Cahaba Dermatology Skin Health Center

Hoover, Alabama, United States

Site Status

Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status

Noble Clinical Research

Tucson, Arizona, United States

Site Status

Johnson Dermatology Clinic

Fort Smith, Arkansas, United States

Site Status

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

Zenith Research, Inc.

Beverly Hills, California, United States

Site Status

UNISON Clinical Trials (Shahram Jacobs md inc.)

Encino, California, United States

Site Status

First OC Dermatology Research Inc.

Fountain Valley, California, United States

Site Status

Long Beach Research Institute, LLC

Long Beach, California, United States

Site Status

Metropolis Dermatology Downtown LA - Probity - PPDS

Los Angeles, California, United States

Site Status

Northridge Clinical Trials

Northridge, California, United States

Site Status

TCR Medical Corporation

San Diego, California, United States

Site Status

University Clinical Trials

San Diego, California, United States

Site Status

Dermatology Institute and Skin Care Center

Santa Monica, California, United States

Site Status

Revival Research Corporation - Florida - ClinEdge - PPDS

Doral, Florida, United States

Site Status

Florida Academic Centers Research

Miami, Florida, United States

Site Status

San Marcus Research Clinic Inc

Miami Lakes, Florida, United States

Site Status

FXM Research Miramar

Miramar, Florida, United States

Site Status

Lenus Research & Medical Group

Sweetwater, Florida, United States

Site Status

Advanced Clinical Research Institute (ACRI) - Florida

Tampa, Florida, United States

Site Status

Olympian Clinical Research - 6331 Memorial Hwy

Tampa, Florida, United States

Site Status

Divine Dermatology and Aesthetics, LLC

Atlanta, Georgia, United States

Site Status

Advanced Medical Research, PC

Atlanta, Georgia, United States

Site Status

Skin Care Physicians of Georgia

Macon, Georgia, United States

Site Status

NorthShore Medical Group Dermatology - Skokie

Skokie, Illinois, United States

Site Status

DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location

Clarksville, Indiana, United States

Site Status

Skin Sciences, PLLC

Louisville, Kentucky, United States

Site Status

DS Research of Kentucky

Louisville, Kentucky, United States

Site Status

Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, United States

Site Status

Lawrence J Green, MD LLC

Rockville, Maryland, United States

Site Status

Allcutis Research LLC

Beverly, Massachusetts, United States

Site Status

Beacon Clinical Research LLC

Brockton, Massachusetts, United States

Site Status

David Fivenson MD Dermatology PLLC

Ann Arbor, Michigan, United States

Site Status

University of Michigan Hospital - 1500 E Medical Center Dr

Ann Arbor, Michigan, United States

Site Status

Oakland Hills Dermatology - 3400 Auburn Rd

Auburn Hills, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Skin Specialists PC

Omaha, Nebraska, United States

Site Status

Vivida Dermatology - Flamingo Rd - Probity - PPDS

Las Vegas, Nevada, United States

Site Status

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, United States

Site Status

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status

Mount Sinai Doctors -234 E 85th St

New York, New York, United States

Site Status

Sadick Research Group

New York, New York, United States

Site Status

Derm Research Center of NY

Stony Brook, New York, United States

Site Status

Montefiore Dermatology - BRANY - PPDS

The Bronx, New York, United States

Site Status

Duke Dermatology Clinic

Durham, North Carolina, United States

Site Status

The Skin Surgery Center for Clinical Research - Objective Health - PPDS

Winston-Salem, North Carolina, United States

Site Status

Wake Forest Baptist Health Department of Dermatology - 4618 Country Club Rd

Winston-Salem, North Carolina, United States

Site Status

ClinOhio Research Services

Columbus, Ohio, United States

Site Status

Wright State Physicians

Fairborn, Ohio, United States

Site Status

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Site Status

Oregon Medical Research Center PC

Portland, Oregon, United States

Site Status

University of Pittsburgh Medical Center-3601 5th Ave

Pittsburgh, Pennsylvania, United States

Site Status

Cumberland Skin Center for Clinical Research - Objective Health - PPDS

Hermitage, Tennessee, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

Arlington Research Center

Arlington, Texas, United States

Site Status

UT Physicians Dermatology - Bellaire Station

Bellaire, Texas, United States

Site Status

Modern Research Associates

Dallas, Texas, United States

Site Status

North Texas Center for Clinical Research

Frisco, Texas, United States

Site Status

Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS

Pflugerville, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Houston Center for Clinical Research, LLC

Sugar Land, Texas, United States

Site Status

Center For Clinical Studies, LTD. LLP - 451 N Texas Ave

Webster, Texas, United States

Site Status

Center For Clinical Studies,LTD. LLP - 451 N Texas Ave

Webster, Texas, United States

Site Status

Virginia Clinical Research - 6160 Kempsville Cir

Norfolk, Virginia, United States

Site Status

Conexa Investigación Clínica S.A.

Buenos Aires, , Argentina

Site Status

STAT Research S.A.

Buenos Aires, , Argentina

Site Status

Instituto de Neumonologia y Dermatologia

Buenos Aires, , Argentina

Site Status

Centro de Investigacion Clínica - CEDIC

Ciudad Autónomade Buenos Aires, , Argentina

Site Status

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, , Argentina

Site Status

Medical Center Unimed EOOD

Sevlievo, Gabrovo, Bulgaria

Site Status

Medical Center Asklepii OOD

Dupnitsa, Kyustendil, Bulgaria

Site Status

MBAL Skin Systems, Doganovo

Elin Pelin, Sofia, Bulgaria

Site Status

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Sofia-Grad, Bulgaria

Site Status

Diagnostic Consultative Centre - Focus-5 - LZIP EOOD

Sofia, Sofia-Grad, Bulgaria

Site Status

Medical Center Hera EOOD

Sofia, Sofia-Grad, Bulgaria

Site Status

Diagnostic Consultative Center XXVIII - Sofia - EOOD

Sofia, Sofia-Grad, Bulgaria

Site Status

Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD

Sofia, Sofia-Grad, Bulgaria

Site Status

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, Bulgaria

Site Status

MC Comac Medical - IRN - PPDS

Sofia, Sofia-Grad, Bulgaria

Site Status

Multiprofile Hospital for Active Treatment - Dobrich AD

Dobrich, , Bulgaria

Site Status

Multiprofile Hospital For Active Treatment Dr Tota Venkova

Gabrovo, , Bulgaria

Site Status

Diagnostic Consultative Center Sveti Georgi EOOD

Haskovo, , Bulgaria

Site Status

Medical Center Medconsult Pleven OOD

Pleven, , Bulgaria

Site Status

Medical Center Exacta Medica - Vasil Levski 60

Pleven, , Bulgaria

Site Status

University Multiprofile Hospital for Active Treatment -Dr. Georgi Stranski -Gen. V. Vazov Str 91

Pleven, , Bulgaria

Site Status

Dermatology Research Institute, Inc. - Probity - PPDS

Calgary, Alberta, Canada

Site Status

Alberta DermaSurgery Centre - Probity - PPDS

Edmonton, Alberta, Canada

Site Status

VIDA Dermatology - Probity - PPDS

Edmonton, Alberta, Canada

Site Status

CaRe Clinic-Red Deer

Red Deer, Alberta, Canada

Site Status

Wiseman Dermatology Research Inc. - Probity - PPDS

Winnipeg, Manitoba, Canada

Site Status

Brunswick Dermatology Centre - Probity - PPDS

Fredericton, New Brunswick, Canada

Site Status

Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS

Hamilton, Ontario, Canada

Site Status

Dermatrials Research

Hamilton, Ontario, Canada

Site Status

DermEffects - Probity - PPDS

London, Ontario, Canada

Site Status

Lynderm Research Inc - Probity - PPDS

Markham, Ontario, Canada

Site Status

DermEdge Research - Probity - PPDS

Mississauga, Ontario, Canada

Site Status

The Centre for Clinical Trials Inc. - Probity - PPDS

Oakville, Ontario, Canada

Site Status

Oshawa Clinic-117 King St

Oshawa, Ontario, Canada

Site Status

SKiN Centre for Dermatology - Peterborough - Probity - PPDS

Peterborough, Ontario, Canada

Site Status

Centre For Dermatology and Cosmetic Surgery - Probity - PPDS

Richmond Hill, Ontario, Canada

Site Status

Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS

Richmond Hill, Ontario, Canada

Site Status

Canadian Dermatology Centre - Probity - PPDS

Toronto, Ontario, Canada

Site Status

Toronto Research Centre - Probity - PPDS

Toronto, Ontario, Canada

Site Status

Alliance Clinical Trials - Probity - PPDS

Waterloo, Ontario, Canada

Site Status

XLR8 Medical Research - Probity - PPDS

Windsor, Ontario, Canada

Site Status

Siena Medical Research

Westmount, Quebec, Canada

Site Status

Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS

Saskatoon, Saskatchewan, Canada

Site Status

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)

Nanjing, Jiangsu, China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

West China Hospital Sichuan University

Chengdu, Sichuan, China

Site Status

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus

Hangzhou, Zhejiang, China

Site Status

Huashan Hospital Fudan University - PPDS

Shanghai, , China

Site Status

Dermamedica, s.r.o. - Kozni Ambulance Nachod

Náchod, Královéhradecký kraj, Czechia

Site Status

Nemocnice AGEL Novy Jicin a.s

Nový Jičín, Moravskoslezský kraj, Czechia

Site Status

CCR Ostrava s.r.o.

Ostrava, Moravskoslezský kraj, Czechia

Site Status

Praglandia s.r.o.

Prague, Ohio, Czechia

Site Status

Dermskin s.r.o.

Olomouc, Olomoucký kraj, Czechia

Site Status

CLINTRIAL s.r.o.

Prague, Praha, Hlavní Mesto, Czechia

Site Status

Pratia Brno s.r.o. - PRATIA - PPDS

Brno, South Moravian, Czechia

Site Status

Pratia Pardubice a.s. - PRATIA - PPDS

Pardubice, , Czechia

Site Status

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status

Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS

Prague, , Czechia

Site Status

Centre Hospitalier Le Mans

Le Mans, Ohio, France

Site Status

AP-HM- Hôpital de La Timone

Marseille, , France

Site Status

Hôpital Charles Nicolle-1 Rue de Germont

Rouen, , France

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

Site Status

Klinische Forschung Dresden GmbH (KFGN) - PRATIA - PPDS

Dresden, Saxony, Germany

Site Status

Praxis fur Dermatologie and Venerologie

Dresden, Saxony, Germany

Site Status

SRH Wald-Klinikum Gera GmbH

Gera, Thuringia, Germany

Site Status

FutureMeds - Berlin - PPDS

Berlin, , Germany

Site Status

Dermatologikum Hamburg

Hamburg, , Germany

Site Status

Medizinisches Versorgungszentrum DermaKiel GmbH

Kiel, , Germany

Site Status

Hospital A.Syggros

Athens, Attica, Greece

Site Status

University General Hospital ''ATTIKON''

Chaïdári, Attica, Greece

Site Status

University Hospital of Ioannina

Loannina, Loannina, Greece

Site Status

Hospital Of Skin And Venereal Diseases of Thessaloniki

Thessaloniki, , Greece

Site Status

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Szegedi Tudomanyegyetem

Szeged, Csongrád megye, Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, Hungary

Site Status

Allergo-Derm Bakos Kft- Szolnok-Baross utca 20

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Somogy County, Hungary

Site Status

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

Szombathely, Vas County, Hungary

Site Status

Pécsi Tudomanyegyetem - Vasvari Pal u.

Pécs, , Hungary

Site Status

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, Jerusalem, Israel

Site Status

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, Israel

Site Status

Tel Aviv Sourasky Medical Center Ichilov - PPDS 27004

Tel Aviv, Tel Aviv, Israel

Site Status

HaEmek Medical Center

Afula, , Israel

Site Status

Rabin Medical Center - PPDS

Petah Tikva, , Israel

Site Status

Adoria

Riga, Ohio, Latvia

Site Status

Smite Aija doctor practice in dermatology, venerology

Talsi, Talsu Aprinkis, Latvia

Site Status

Semigallia

Kuldīga, , Latvia

Site Status

Riga 1st Hospital

Riga, , Latvia

Site Status

Health Center 4, Center of Diagnostics

Riga, , Latvia

Site Status

J. Kisis

Riga, , Latvia

Site Status

Veseliba un estetika

Riga, , Latvia

Site Status

Health Center 4, Clinic of Dermatology

Riga, , Latvia

Site Status

Solumed Centrum Medyczne

Poznan, Greater Poland Voivodeship, Poland

Site Status

Twoja Przychodnia PCM

Poznan, Greater Poland Voivodeship, Poland

Site Status

Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Krakowskie Centrum Medyczne - FutureMeds - PPDS

Krakow, Lesser Poland Voivodeship, Poland

Site Status

WroMedica

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

Lublin, Lublin Voivodeship, Poland

Site Status

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship, Poland

Site Status

Centrum Terapii Wspolczesnej

Lódz, Lódzkie, Poland

Site Status

ClinMedica Research

Skierniewice, Lódzkie, Poland

Site Status

ETG Siedlce - PPDS

Siedlce, Masovian Voivodeship, Poland

Site Status

RCMed Oddzial Sochaczew

Sochaczew, Masovian Voivodeship, Poland

Site Status

Clinical Research Group Sp. z o.o

Warsaw, Masovian Voivodeship, Poland

Site Status

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

Warsaw, Masovian Voivodeship, Poland

Site Status

ETG Warszawa - PPDS

Warsaw, Masovian Voivodeship, Poland

Site Status

FutureMeds - Targowek - PPDS

Warsaw, Masovian Voivodeship, Poland

Site Status

MICS Centrum Medyczne Torun - MICS - PPDS

Torun, Ohio, Poland

Site Status

NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Centrum Medyczne Chojnice - PRATIA - PPDS

Chojnice, Pomeranian Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Site Status

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

Gdynia, Pomeranian Voivodeship, Poland

Site Status

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

Katowice, Silesian Voivodeship, Poland

Site Status

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Site Status

Pro Familia Altera Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Site Status

Centrum Uslug Medycznych MaxMed

Bochnia, , Poland

Site Status

Ambulatorium Barbara Bazela

Elblag, , Poland

Site Status

Globe Badania Kliniczne Spólka z o.o. - Klodzko

Klodzko Dolnoslaskie, , Poland

Site Status

MCM Krakow - PRATIA - PPDS

Krakow, , Poland

Site Status

Diamond Clinic

Krakow, , Poland

Site Status

ETG Lublin - PPDS

Lublin, , Poland

Site Status

ETYKA Osrodek Badan Klinicznych

Olsztyn, , Poland

Site Status

DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.

Osielsko, , Poland

Site Status

Royalderm

Warsaw, , Poland

Site Status

dermMEDICA Sp. z o.o

Wroclaw, , Poland

Site Status

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Site Status

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Site Status

GCM Medical Group, PSC -62 Calle Jose Marti

San Juan, , Puerto Rico

Site Status

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital de Manises

Manises, Valencia, Spain

Site Status

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario La Paz - PPDS

Madrid, , Spain

Site Status

Velocity Clinical Research, High Wycombe - PPDS

High Wycombe, Buckinghamshire, United Kingdom

Site Status

4 Medical Clinical Solutions (4MCS) Swinton - PPDS

Ilford, Essex, United Kingdom

Site Status

Accellacare of Yorkshire

Chorley, Lancashire, United Kingdom

Site Status

Salford Royal Hospital - PPDS

Salford, Lancashire, United Kingdom

Site Status

Whipps Cross Hospital

London, London, City of, United Kingdom

Site Status

Accellacare of Northamptonshire

Harrow, Middlesex, United Kingdom

Site Status

Velocity Clinical Research, North London - PPDS

London, Middlesex, United Kingdom

Site Status

Accellacare - North London Clinical Studies Centre

Northwood, Middlesex, United Kingdom

Site Status

St Luke's Hospital

Bradford, West Yorkshire, United Kingdom

Site Status

Countries

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United States Argentina Bulgaria Canada China Czechia France Germany Greece Hungary Israel Latvia Poland Puerto Rico Spain United Kingdom

Related Links

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https://clinicaltrials.takeda.com/study-detail/516bd1c8c4dd4621

To obtain more information on the study, click here/on this link

Other Identifiers

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2023-505842-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-279-3002

Identifier Type: -

Identifier Source: org_study_id

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