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
- Conditions
- Crohn's Disease
- Interventions
- Drug: TAK-279Drug: Placebo
- Registration Number
- NCT06233461
- Lead Sponsor
- Takeda
- 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 any 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.t
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 268
-
Male or female aged 18-75 years old with diagnosis of CD for at least 30 days.
-
Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
-
Participants must have received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both):
- Participants must have had an history of inadequate response to, loss of response to, or intolerance to these therapies based on Physician assessment: 6-mercaptopurine or azathioprine, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms).
- Have received treatment with ≥1 biologic agents (such as tumor necrosis factor (TNF) antagonists, antibodies to interleukin (IL) -23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as Janus kinase inhibitor (JAKi) or sphingosine-1-phosphate (S1P) receptor modulators).
-
Participants must meet the contraception recommendations.
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- Have complications of CD that might require surgery during the study.
- Participants with a current ostomy.
- Participants who have failed 3 or more classes of advanced therapies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAK-279 Dose 1 TAK-279 Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally. TAK-279 Dose 1 Placebo Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally. TAK-279 Dose 2 TAK-279 Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally. TAK-279 Dose 2 Placebo Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally. TAK-279 Dose 3 TAK-279 Participants will be randomized to receive TAK-279 Dose 3 capsules orally. Placebo Placebo Participants will be randomized to receive TAK-279 placebo-matching capsules orally.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 Week 12 Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12 Week 12 Clinical remission is defined as a CDAI score of \<150 points.
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12 Week 12 Clinical response is defined as \>=100-point decrease from Baseline in CDAI score.
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12. Week 12 Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1.
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12 Week 12 Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score \<=2.8 and not worse than baseline and average daily abdominal pain (AP) score \<=1 and not worse than baseline.
Percentage of Participants With a Clinical Response in PRO2 at Week 12 Week 12 Clinical response based on PRO2 is defined as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from baseline.
Percentage of Participants With no Bowel Urgency at Week 12 Week 12 Bowel urgency is assessed using a 1-item daily patient diary that asks participants to indicate if they had an urgent bowel movement (when they felt the need to rush to the toilet to avoid an accident) in the past 24 hours. Response options, "Yes" or "No" will be coded as numeric values.
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12 Week 12 The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12 Baseline to Week 12 The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12 Baseline to Week 12 FACIT-Fatigue questionnaire contains 13 fatigue-related questions. 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.
Trial Locations
- Locations (166)
GastroIntestinal BioSciences
🇺🇸Los Angeles, California, United States
United Medical Doctors
🇺🇸Murrieta, California, United States
UCI Health
🇺🇸Orange, California, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
🇺🇸Clearwater, Florida, United States
Auzmer Research
🇺🇸Lakeland, Florida, United States
Wellness Clinical Research
🇺🇸Miami Lakes, Florida, United States
GI PROS, Inc.
🇺🇸Naples, Florida, United States
USF Health Morsani Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States
Emory University Hospital, The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Atlanta Center For Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
The University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
University Of Louisville
🇺🇸Louisville, Kentucky, United States
Woodholme Gastroenterology Associates
🇺🇸Glen Burnie, Maryland, United States
BVL Clinical Research
🇺🇸Liberty, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
🇺🇸New York, New York, United States
DiGiovanna Institute for Medical Education and Research
🇺🇸North Massapequa, New York, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Hightower Clinical - SSM Health
🇺🇸Oklahoma City, Oklahoma, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Gastroenterology Associates, PA
🇺🇸Greenville, South Carolina, United States
Novel Research, LLC
🇺🇸Bellaire, Texas, United States
TDDC - Baylor University Medical Center Gaston Ave
🇺🇸Dallas, Texas, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
🇺🇸Fort Worth, Texas, United States
TDDC dba Alliance Research
🇺🇸Mansfield, Texas, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
Tidewater Gastroenterology, P.L.L.C. d/b/a Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Nepean Clinical School
🇦🇺Kingswood, New South Wales, Australia
Concord Repatriation General Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Western Health/Footscray Hospital
🇦🇺Melbourne, Victoria, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
🇧🇪Brussels, Anderlecht / Region Capitale De Bruxelles/ Brussel, Belgium
CHU Saint-Pierre - Porte de Hal
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Heritage Medical Research Clinic - University Of Calgary
🇨🇦Calgary, Alberta, Canada
Fraser Clinical Trials
🇨🇦New Westminster, British Columbia, Canada
(G.I.R.I) GI Research Institute Foundation
🇨🇦Vancouver, British Columbia, Canada
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
The Research Institute of the McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Chongqing General Hospital
🇨🇳Chongqing, Chongqing Sheng, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat-sen University (SYSU) - The First Affiliated Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
🇨🇳Shenyang, Liaoning Sheng, China
Shanghai Jiao Tong University School of Medicine - Ruijing hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
🇨🇳Guangzhou, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
🇨🇳Hangzhou, China
Shanghai Pudong New District Zhoupu Hospital
🇨🇳Shanghai, China
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava (FNO)
🇨🇿Ostrava-Poruba, Czechia
Axon Clinical s.r.o.
🇨🇿Praha 5, Czechia
Odense Universitetshospital (OUH) (Odense University Hospital)
🇩🇰Odense, Syddanmark, 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
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
🇫🇷Chambray-les-Tours, France
CHU De Clermont Ferrand - Hopital Estaing
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
🇫🇷Montpellier, France
Hopital l'Archet 2
🇫🇷Nice Cedex 3, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Nord Chu Saint-Etienne
🇫🇷Saint Etienne, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
🇫🇷Toulouse, France
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
🇫🇷Vandoeuvre les Nancy, France
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt Am Main, Germany
Universitaetsklinik Frankfurt
🇩🇪Frankfurt, Germany
Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
🇩🇪Hamburg, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
🇩🇪Kiel, Germany
St. Marien- und St. Annastiftskrankenhaus
🇩🇪Ludwigshafen, Germany
Universitaetsklinikum Mannheim GmbH
🇩🇪Mannheim, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
University Hospital Of Ulm, Universitatsklinikum Ulm
🇩🇪Ulm, Germany
University General Hospital of Patras
🇬🇷Patras, Achaia, Greece
Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
🇬🇷Athens, Attiki, Greece
University of Athens School of Medicine, Alexandra General Hospital
🇬🇷Athens, Attiki, Greece
University Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
Sotiria General Hospital of Athens
🇬🇷Athens, Greece
G.N.A. Gennimatas
🇬🇷Athens, Greece
Clinexpert
🇭🇺Budapest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Pannonia Maganorvosi Centrum Kft.
🇭🇺Budapest, Hungary
IRCCS - AOU di Bologna - SantOrsola Malpighi
🇮🇹Bologna, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena - Clinica Mangiagalli
🇮🇹Milano, Italy
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
🇮🇹Palermo, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
🇮🇹Roma, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
🇮🇹Rozzano, Italy
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
🇯🇵Nishinomiya-city, Hyogo, Japan
Iwate Medical University - Uchimaru Medical Center
🇯🇵Morioka, Iwate, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu city, Shizuoka, Japan
The jikei University Hospital
🇯🇵Minato, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka-City, Tokyo, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Tokyo Medical and Dental University, Medical Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center (AMC)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Zuyderland Medisch Centrum - Sittard-Geleen
🇳🇱Geleen, Limburg, Netherlands
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
🇳🇱Amsterdam, Netherlands
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Vestre Viken HF - Baerum Sykehus
🇳🇴Drammen, Akershus, Norway
Akershus University Hospital
🇳🇴Lorenskog, Akershus, Norway
Oslo Univeristy Hospital Ulleval Hospital
🇳🇴Oslo, Norway
Centrum Medyczne Melita Medical
🇵🇱Wroclaw, Dolnoslaskie, Poland
PlanetMed Sp. z o.o.
🇵🇱Wroclaw, Dolnoslaskie, Poland
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
🇵🇱Torun, Kujawsko-pomo, Poland
AmiCare Sp. z o.o. Sp. k.
🇵🇱Lodz, Lodzkie, Poland
Medicome Sp. z o.o.
🇵🇱Oswiecim, Malopolskie, Poland
Panstwowy Instytut Medyczny MSWiA
🇵🇱Warszawa, Mazowieckie, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Zachodniopomorskie, Poland
Manermed Sp. z o.o - CM Medis
🇵🇱Bydgoszcz, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
Centrum Medyczne Med-Gastr
🇵🇱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
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
🇵🇱Tychy, Poland
Wojskowy Instytut Medyczny
🇵🇱Warsaw, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warsaw, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
🇵🇱Wroclaw, Poland
ETG Zamosc
🇵🇱Zamosc, Poland
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
🇷🇴Timisoara, Jud Timis, Romania
Clinical Hospital Colentina-Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
Clinica Medicum
🇷🇴Bucharest, Romania
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
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, Slovakia
Hospital Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
University Hospital Basel
🇨🇭Basel, Switzerland
Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
🇨🇭Bern, Switzerland
Changhua Christian Hospital (CCH)
🇨🇳Changhua City, Changhua County, Taiwan
National Taiwan University Hospital (NTUH)
🇨🇳Taipei City, Zhongzheng District, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
🇬🇧London, E1 2at, United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
🇬🇧Belfast, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
St George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
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