Clinical trial NCT06254950: A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Drug Therapy
Latitude UC, Latitude Research Program
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 207
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: The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.

The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).

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

Detailed description: Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

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

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of UC 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 UC assessed by mMS and ES.
3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
4. Participants must meet the contraception recommendations.

Exclusion Criteria:

1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Symptomatic Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Remission 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 no Abdominal Pain 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 Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
timeFrame: Baseline and 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: 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: Holden Comprehensive Cancer Center, University of Iowa Hospitals and 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: Rochester Clinical Research
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education and Research
state: New York
city: Oklahoma City
country: United States
facility: Hightower Clinical - SSM Health
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology
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: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
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: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Western Health/Footscray Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital Lung Institute Of Western Australia
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Epping
country: Australia
facility: Northern Hospital Epping
city: Murdoch
country: Australia
facility: Harry Perkins Medical Research Institute Fiona Stanley Hospital
city: Brussels
country: Belgium
facility: Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
state: Anderlecht / Region Capitale De Bruxelles/ Brussel
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
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: Pecs University Clinical Center Mohacs Hospital
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: University Hospital City Clinic Cancer Center
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: 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: 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: Guangzhou
country: China
facility: Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
state: Guangdong
city: Wuhan
country: China
facility: Wuhan University - Renmin Hospital (Hubei General Hospital)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The Second People's Hospital of Changzhou
state: Jiangsu
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: Renji hospital shanghai jiao tong university school of medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
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: Prague 5
country: Czechia
facility: Endohope Clinic
city: Praha 5
country: Czechia
facility: Axon Clinical s.r.o.
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: Nice Cedex 3
country: France
facility: Hopital l'Archet 2
city: Saint Etienne
country: France
facility: Hopital Nord Chu Saint-Etienne
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: Hamburg
country: Germany
facility: Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Hannover Medical School
city: Heidelberg
country: Germany
facility: Praxis fur Gastroenterologie
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: Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
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: Vac
country: Hungary
facility: Javorszky Odon Korhaz
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospital
city: Beer-Sheva
country: Israel
facility: Soroka Mc
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
city: Bologna
country: Italy
facility: IRCCS A.O.U. Policlinico S. Orsola - Malpighi
city: Milan
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Rozzano
country: Italy
facility: IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
city: Torino
country: Italy
facility: AO Ordine Mauriziano di Torino
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Minato
country: Japan
facility: The jikei University Hospital
state: Tokyo
city: Mitaka-City
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Saga
country: Japan
facility: Saga 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: Yeungnam University Medical Center
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: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Lorenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Drammen
country: Norway
facility: Vestre Viken HF - Baerum Sykehus
state: Gjettum
city: Oslo
country: Norway
facility: Oslo Univeristy Hospital Ulleval Hospital
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
state: Dolnolskie
city: Wroclaw
country: Poland
facility: PlanetMed Sp. z o.o.
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
state: Kujawsko-pomorskie
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: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA
state: Mazowieckie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
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 MedykSp. 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 Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
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: Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti
city: Bucuresti
country: Romania
facility: Delta Health Care
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: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon (HGUGM)
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital (CCH)
state: Changhua County
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
state: Zhongzheng District
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University 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: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
state: Greater London
city: Belfast
country: United Kingdom
facility: South Eastern Health and Social Care Trust - The Ulster Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Clinical Research Centre - Barts Health NHS Trust
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: