Clinical trial NCT06233461: A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Drug Therapy
Latitude CD, Latitude Research Program
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.

The participants will be treated with TAK-279 for 52 weeks (1 year).

During the study, participants will visit their study clinic 15 times.

Detailed description: The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.

The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. TAK-279 Dose 3
4. Placebo

This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age.
2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

Exclusion Criteria:

1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
2. Have complications of CD that might require surgery during the study.
3. Participants with a current ostomy.
4. Participants who have failed 3 or more classes of advanced therapies.

Primary outcomes:
measure: Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a Clinical Response in PRO2 at Week 12
timeFrame: Week 12
measure: Percentage of Participants With no Bowel Urgency at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12
timeFrame: Week 12
measure: Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
timeFrame: Baseline to Week 12
measure: Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GastroIntestinal BioSciences
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Orange
country: United States
facility: UCI Health
state: California
city: Clearwater
country: United States
facility: West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Naples
country: United States
facility: GI PROS, Inc.
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center for Advanced Healthcare
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital, The Emory Clinic
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology, P.C.
state: Georgia
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Liberty
country: United States
facility: BVL Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical - SSM Health
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology Providence
state: Rhode Island
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Bellaire
country: United States
facility: Novel Research, LLC
state: Texas
city: Dallas
country: United States
facility: TDDC - Baylor University Medical Center Gaston Ave
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
state: Texas
city: Mansfield
country: United States
facility: TDDC dba Alliance Research
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Chesapeake
country: United States
facility: Tidewater Gastroenterology, P.L.L.C. d/b/a Gastroenterology Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Kingswood
country: Australia
facility: Nepean Clinical School
state: New South Wales
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre-Mater Health Services
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network - Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Western Health/Footscray Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Harry Perkins Medical Research Institute Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Epping
country: Australia
facility: Northern Hospital Epping
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
city: Brussels
country: Belgium
facility: Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
state: Anderlecht / Region Capitale De Bruxelles/ Brussel
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre - Porte de Hal
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
city: Plovdiv
country: Bulgaria
facility: UMBAL Kaspela
city: Sliven
country: Bulgaria
facility: Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
city: Sofia
country: Bulgaria
facility: Acibadem City clinic Tokuda hospital
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Mladost Hospital
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic - University Of Calgary
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials
state: British Columbia
city: Vancouver
country: Canada
facility: (G.I.R.I) GI Research Institute Foundation
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: The Research Institute of the McGill University Health Center
state: Quebec
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing Sheng
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University (SYSU) - The First Affiliated Hospital
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
state: Liaoning Sheng
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine - Ruijing hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Guangzhou
country: China
facility: Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
city: Shanghai
country: China
facility: Shanghai Pudong New District Zhoupu Hospital
city: Horovice
country: Czechia
facility: NH Hospital
state: Stredocesky
city: Brno
country: Czechia
facility: SurGal Clinic SRO
city: Brno
country: Czechia
facility: Vojenska Nemocnice Brno
city: Brno
country: Czechia
facility: University Hospital Brno
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice, a.s.
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Ostrava-Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava (FNO)
city: Ostrava
country: Czechia
facility: EndoArt
city: Pardubice
country: Czechia
facility: Gastromedic s.r.o
city: Praha 5
country: Czechia
facility: Axon Clinical s.r.o.
city: Praha
country: Czechia
facility: Endohope Clinic
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital (OUH) (Odense University Hospital)
state: Syddanmark
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Esbjerg
country: Denmark
facility: Sydvestjysk Region/Esbjerg Hospital
city: Hillerod
country: Denmark
facility: Hillerod Hospital, Hilleroed Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
city: Koge
country: Denmark
facility: Region Sjaelland Sygehus Nord, Koge Sygehus
city: Chambray-les-Tours
country: France
facility: Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
city: Clermont-Ferrand
country: France
facility: CHU De Clermont Ferrand - Hopital Estaing
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
city: Nice Cedex 3
country: France
facility: Hopital l'Archet 2
city: Saint Etienne
country: France
facility: Hopital Nord Chu Saint-Etienne
city: Toulouse cedex 09
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
city: Vandoeuvre les Nancy
country: France
facility: Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
city: Frankfurt Am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt
country: Germany
facility: Universitaetsklinik Frankfurt
city: Hamburg
country: Germany
facility: Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
city: Ludwigshafen
country: Germany
facility: St. Marien- und St. Annastiftskrankenhaus
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim GmbH
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: University Hospital Of Ulm, Universitatsklinikum Ulm
city: Patras
country: Greece
facility: University General Hospital of Patras
state: Achaia
city: Athens
country: Greece
facility: Evangelismos Hospital
state: Attiki
city: Athens
country: Greece
facility: University of Athens School of Medicine, Alexandra General Hospital
state: Attiki
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: Sotiria General Hospital of Athens
city: Athens
country: Greece
facility: G.N.A. Gennimatas
city: Budapest
country: Hungary
facility: Clinexpert
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Beer-Sheva
country: Israel
facility: Soroka Mc
city: Jerusalem
country: Israel
facility: Digestive Disease Institute, Shaare Zedek Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
city: Tel Aviv
country: Israel
facility: The Chaim Sheba Medical Centre
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna - SantOrsola Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena - Clinica Mangiagalli
city: Milano
country: Italy
facility: Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
city: Roma
country: Italy
facility: A. Gemelli University Hospital, Catholic University of the Sacred Heart
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Rozzano
country: Italy
facility: IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Nishinomiya-city
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Hamamatsu city
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Minato
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Mitaka-City
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Tokyo
country: Japan
facility: Institute of Science Tokyo Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center (AMC)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard-Geleen
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Drammen
country: Norway
facility: Vestre Viken HF - Baerum Sykehus
state: Akershus
city: Lorenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Oslo
country: Norway
facility: Oslo Univeristy Hospital Ulleval Hospital
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: PlanetMed Sp. z o.o.
state: Dolnoslaskie
city: Torun
country: Poland
facility: Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
state: Kujawsko-pomo
city: Lodz
country: Poland
facility: AmiCare Sp. z o.o. Sp. k.
state: Lodzkie
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
state: Malopolskie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA
state: Mazowieckie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: Manermed Sp. z o.o - CM Medis
city: Lodz
country: Poland
facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
city: Lodz
country: Poland
facility: Centrum Medyczne Med-Gastr
city: Lublin
country: Poland
facility: Medrise sp. z o.o
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk Sp. z o.o. Sp. K.
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne Sp. z o.o. Sp.k.
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Timisoara
country: Romania
facility: Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
state: Jud Timis
city: Bucharest
country: Romania
facility: Clinical Hospital Colentina-Spitalul Clinic Colentina
city: Bucharest
country: Romania
facility: Clinica Medicum
city: Bucharest
country: Romania
facility: Spital Clinic Dr I Cantacuzino
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Euroclinic
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica F. D. Roosevelta
city: Bratislava
country: Slovakia
facility: Cliniq s. r. o.
city: Kosice
country: Slovakia
facility: Endomed
city: Nove Zamky
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou Nove Zamky
city: Sahy
country: Slovakia
facility: Accout Center, s.r.o.- Gastroenterologicka ambulancia
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Dr. Negrin
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Koahsiung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: London
country: United Kingdom
facility: Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
state: E1 2at
city: Belfast
country: United Kingdom
facility: South Eastern Health and Social Care Trust - The Ulster Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: