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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254950
• Other study ID #: TAK-279-UC-2001
• Secondary ID: 2023-506769-67
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2024
• Est. completion date: August 4, 2027

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 207
• Est. completion date: August 4, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days.

2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.

3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• TAK-279
TAK-279 capsules.
• Placebo
TAK-279 placebo-matching capsules.

Locations

Country	Name	City	State
Belgium	Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel	Brussels	Anderlecht / Region Capitale De Bruxelles/ Brussel
Belgium	Universitair Ziekenhuis Leuven	Leuven
Canada	Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	London Health Sciences Centre - Victoria Hospital	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Research Institute of the McGill University Health Center	Montreal	Quebec
Canada	Fraser Clinical Trials	New Westminster	British Columbia
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava (FNO)	Ostrava-Poruba
Czechia	Endogastro Praha s.r.o	Praha
Czechia	Axon Clinical s.r.o.	Praha 5
Denmark	Aalborg Hospital	Aalborg
Denmark	Sydvestjysk Region/Esbjerg Hospital	Esbjerg
Denmark	Hillerod Hospital, Hilleroed Sygehus	Hillerod
Denmark	Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling	Hvidovre
Denmark	Region Sjaelland Sygehus Nord, Koge Sygehus	Koge
Denmark	Odense Universitetshospital (OUH) (Odense University Hospital)	Odense	Syddanmark
France	CHU De Clermont Ferrand - Hopital Estaing	Clermont-Ferrand
France	Institut des MICI, Groupe Hospitalier Prive Ambroise Pare-Hartmann	Neuilly Sur Seine
France	Hopital l'Archet 2	Nice Cedex 3
France	Hopital Saint Antoine	Paris
France	Hopital Nord Chu Saint-Etienne	Saint Etienne
France	Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois	Vandoeuvre les Nancy
Germany	Agaplesion Markus Krankenhaus	Frankfurt Am Main
Germany	Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)	Hamburg
Germany	Praxis fur Gastroenterologie	Heidelberg
Germany	Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel	Kiel
Germany	St. Marien- und St. Annastiftskrankenhaus	Ludwigshafen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	University Hospital Of Ulm, Universitatsklinikum Ulm	Ulm
Greece	Evaggelismos Hospital (Evangelismos Hospital)-University of Athens	Athens	Attiki
Greece	G.N.A. Gennimatas	Athens
Greece	Sotiria General Hospital of Athens	Athens
Greece	University Hospital of Heraklion	Heraklion	Crete
Greece	University General Hospital of Patras	Patras	Achaia
Hungary	Clinexpert	Budapest
Hungary	Pannonia Maganorvosi Centrum Kft.	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Javorszky Odon Korhaz	Vac
Italy	IRCCS A.O.U. Policlinico S. Orsola - Malpighi	Bologna
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital	Milan
Italy	Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello	Palermo
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	IRCCS Istituto clinico humanitas - Humanitas Mirasole spa	Rozzano
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	The jikei University Hospital	Minato	Tokyo
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Kyorin University Hospital	Mitaka-City	Tokyo
Japan	Saga University Hospital	Saga
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Asan Medical Center (AMC)	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gangwon
Norway	Vestre Viken HF - Baerum Sykehus	Drammen	Gjettum
Norway	Akershus University Hospital	Lorenskog	Akershus
Norway	Oslo Univeristy Hospital Ulleval Hospital	Oslo
Norway	Universitetssykehuset Nord-Norge - Tromso (Regionsykehuset i Tromso)	Tromso
Poland	Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Medrise sp. z o.o	Lublin
Poland	Centrum Medyczne MedykSp. z o.o. Sp. K.	Rzeszow
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie	Torun	Kujawsko-pomo
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw
Poland	Panstwowy Instytut Medyczny MSWiA	Warszawa	Mazowieckie
Poland	Centrum Medyczne Melita Medical	Wroclaw	Dolnolskie
Poland	PlanetMed Sp. z o.o.	Wroclaw	Dolnoslaskie
Romania	Clinica Medicum	Bucharest
Romania	Clinical Hospital Colentina-Spitalul Clinic Colentina	Bucharest
Romania	Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti	Bucuresti
Romania	Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis	Timisoara	Jud Timis
Slovakia	Fakultna nemocnica F. D. Roosevelta	Banska Bystrica
Slovakia	Cliniq s. r. o.	Bratislava
Slovakia	Endomed	Kosice
Slovakia	Fakultna Nemocnica s poliklinikou Nove Zamky	Nove Zamky
United Kingdom	South Eastern Health and Social Care Trust - The Ulster Hospital	Belfast
United Kingdom	South Eastern Health and Social Care Trust - The Ulster Hospital	Belfast
United Kingdom	Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Clinical Research Centre - Barts Health NHS Trust	London	E1 2at
United Kingdom	St George's University Hospitals NHS Foundation Trust	London	Greater London
United Kingdom	St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust	London
United States	Emory University Hospital, The Emory Clinic	Atlanta	Georgia
United States	Novel Research, LLC	Bellaire	Texas
United States	West Central Gastroenterology, LLP, d/b/a/ Gastro Florida	Clearwater	Florida
United States	Atlanta Center For Gastroenterology, P.C.	Decatur	Georgia
United States	Woodholme Gastroenterology Associates	Glen Burnie	Maryland
United States	Gastroenterology Associates, PA	Greenville	South Carolina
United States	Victorium Clinical Research	Houston	Texas
United States	Auzmer Research	Lakeland	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	GastroIntestinal BioSciences	Los Angeles	California
United States	University Of Louisville	Louisville	Kentucky
United States	United Medical Doctors	Murrieta	California
United States	GI PROS, Inc.	Naples	Florida
United States	DiGiovanna Institute for Medical Education and Research	North Massapequa	New York
United States	Hightower Clinical - SSM Health	Oklahoma City	Oklahoma
United States	University of Washington Medical Center	Seattle	Washington
United States	USF Tampa General Hospital	Tampa	Florida
United States	Tyler Research Institute, LLC	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Romania,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)	The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of =2 with SF subscore = 1, RB subscore = 0, and ES = 1 (score of 1 modified to exclude friability).	Week 12
Secondary	Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)	Clinical response defined as reduction from baseline in mMS of =2 points and =30% from baseline and a decrease from baseline in the RB subscore of =1 point or an absolute RB subscore of =1 point at Week 12.	Baseline, Week 12
Secondary	Percentage of Participants Achieving Symptomatic Remission at Week 12	Symptomatic remission is defined as a RB subscore of 0 and SF subscore of =1.	Week 12
Secondary	Percentage of Participants Achieving Endoscopic Improvement at Week 12	Endoscopic improvement defined as a modified Mayo ES of =1 (score of 1 modified to exclude friability).	Week 12
Secondary	Percentage of Participants Achieving Endoscopic Remission at Week 12	Endoscopic remission defined as a modified Mayo ES of 0.	Week 12
Secondary	Percentage of Participants With no Bowel Urgency at Week 12	Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.	Week 12
Secondary	Percentage of Participants With no Abdominal Pain at Week 12	Abdominal pain measured by abdominal pain eDiary item at Week 12.	Week 12
Secondary	Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score =170 at Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Week 12
Secondary	Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Baseline and Week 12
Secondary	Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12	The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.	Baseline and Week 12

External Links

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