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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233461
• Other study ID #: TAK-279-CD-2001
• Secondary ID: 2023-506704-14
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2024
• Est. completion date: July 23, 2027

Study information

• Verified date: June 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

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

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 patients. 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 information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: July 23, 2027
• Est. primary completion date: September 18, 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 CD for at least 30 days.

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 conventional or biologic therapy for CD.

4. Participants must meet the contraception recommendations.

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Nepean Clinical School	Kingswood	New South Wales
Australia	Western Health/Footscray Hospital	Melbourne	Victoria
Australia	Concord Repatriation General Hospital	Sydney	New South Wales
Belgium	Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel	Brussels	Anderlecht / Region Capitale De Bruxelles/ Brussel
Belgium	CHU Saint-Pierre - Porte de Hal	Bruxelles
Belgium	Algemeen Ziekenhuis Maria Middelares	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman	Liege
Canada	Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta
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	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Fraser Clinical Trials	New Westminster	British Columbia
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Immune and Digestive Health Institute (TIDHI)	Toronto	Ontario
Canada	GI Research Institute (G.I.R.I.)	Vancouver	British Columbia
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Chongqing General Hospital	Chongqing	Chongqing Sheng
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University (SYSU) - The First Affiliated Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University (SYSU) - The First Affiliated Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)	Hangzhou	Zhejiang
China	Shanghai Jiao Tong University School of Medicine - Ruijing hospital	Shanghai	Shanghai
China	Shanghai Pudong New District Zhoupu Hospital	Shanghai
China	Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	China Medical University (CMU) - First Affiliated Hospital	Shenyang	Liaoning Sheng
China	China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus	Shenyang	Liaoning Sheng
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Zhejiang Chinese Medical University	Zhejiang	Zhejiang
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava (FNO)	Ostrava-Poruba
Czechia	Thomayerova Nemocnice (TN) - I. Interni Klinika FTNsP/IPVZ	Prague
Czechia	Endogastro Praha s.r.o	Praha
Czechia	Axon Clinical s.r.o.	Praha 5
Czechia	IBD Clinical and Research centre	Praha 9
Denmark	Aalborg Hospital	Aalborg
Denmark	Bispebjerg Hospital, University of Copenhagen	Copenhagen Nv
Denmark	Sydvestjysk Region/Esbjerg Hospital	Esbjerg
Denmark	Hillerod Hospital, Hilleroed Sygehus	Hillerod
Denmark	Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling	Hvidovre
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	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	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 Universitaire de Toulouse - Hopital Rangueil	Toulouse
France	Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil	Toulouse cedex 09
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	Medizinische Hochschule Hannover, Hannover Medical School	Hannover
Germany	Praxis fur Gastroenterologie	Heidelberg
Germany	Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel	Kiel
Germany	Medius Klinik Nuertingen, St. Marien- und St. Annastiftskrankenhaus	Ludwigshafen
Germany	Universitaetsklinikum Mannheim GmbH	Mannheim
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 of Athens School of Medicine, Alexandra General Hospital	Athens	Attiki
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	Synexus DRS Budapest	Budapest
Italy	IRCCS A.O.U. Policlinico S. Orsola - 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	Complesso Integrato Columbus	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	A.S.O Ordine Mauriziano Di Torino	Torino
Japan	Fukuoka University Hospital	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Ofuna Chuo Hospital	Kamakura-shi	Kanagawa
Japan	The jikei University Hospital	Minato	Tokyo
Japan	Kyorin University Hospital	Mitaka-City	Tokyo
Japan	Iwate Medical University - Uchimaru Medical Center	Morioka	Iwate
Japan	Hyogo Medical University Hospital	Nishinomiya-city	Hyogo
Japan	Saga University Hospital	Saga
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka
Japan	Tokyo Medical and Dental University, Medical Hospital	Tokyo
Japan	Toyama University Hospital	Toyama
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	Asan Medical Center (AMC)	Seoul
Korea, Republic of	Asan Medical Center (AMC)	Seoul
Korea, Republic of	Chung-Ang University Hospital	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
Netherlands	Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)	Amsterdam
Netherlands	Amsterdam University Medical Center (Amsterdam UMC), VU University Medical Center	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG) - Locatie Oost	Amsterdam
Netherlands	Zuyderland Medisch Centrum - Sittard-Geleen	Geleen	Limburg
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Norway	Vestre Viken HF - Baerum Sykehus	Drammen	Akershus
Norway	Akershus University Hospital	Lorenskog	Akershus
Norway	Oslo Univeristy Hospital Ulleval Hospital	Oslo
Norway	Oslo Universitetssykehus HF, Ulleval	Oslo
Norway	Universitetssykehuset Nord-Norge - Tromso (Regionsykehuset i Tromso)	Tromso
Poland	NZOZ Specjalistyczne Centrum Gastrologii GASTROMED	Bialystok
Poland	Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	AmiCare Sp. z o.o. Sp. k.	Lodz	Lodzkie
Poland	Centrum Medyczne Med-Gastr	Lodz
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	Medicome Sp. z o.o.	Oswiecim	Malopolskie
Poland	Centrum Medyczne Medyk Sp. z o.o. Sp. K.	Rzeszow
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Sonomed	Szczecin	Zachodniopomorskie
Poland	Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie	Torun	Kujawsko-pomo
Poland	H-T. Centrum Medyczne Sp. z o.o. Sp.k.	Tychy
Poland	WIP Warsaw IBD Point Profesor Kierkus, WIP Warsaw IBD Point Profesor Kierkus	Warsaw
Poland	Wojskowy Instytut Medyczny	Warsaw
Poland	Panstwowy Instytut Medyczny MSWiA	Warszawa	Mazowieckie
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy	Wroclaw
Poland	Centrum Medyczne Melita Medical	Wroclaw	Dolnoslaskie
Poland	PlanetMed Sp. z o.o.	Wroclaw	Dolnoslaskie
Poland	ETG Zamosc	Zamosc
Romania	Clinica Medicum	Bucharest
Romania	Clinical Hospital Colentina-Spitalul Clinic Colentina	Bucharest
Romania	Institutul Clinic Fundeni	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
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada
Spain	Hospital Juan Ramon Jimenez	Huelva
Spain	Hospital Dr. Negrin	Las Palmas De Gran Canaria
Spain	Hospital General Universitario Gregorio Maranon (HGUGM)	Madrid
Spain	Hospital Universitario La Paz	Madrid
Switzerland	University Hospital Basel	Basel
Switzerland	Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern	Bern
Switzerland	Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern	Bern
Switzerland	University Hospital Bern (Inselspital)	Bern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Universitatsspital Zurich	Zurich
Taiwan	Changhua Christian Hospital (CCH)	Changhua City	Changhua County
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Taiwan University Hospital (NTUH)	Taipei City	Zhongzheng District
Taiwan	Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital	Taoyuan City
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	Cambridgeshire
United Kingdom	Spire Parkway Hospital, University Hospital Coventry - University Hospitals Coventry and Warwickshire NHS Trust	Coventry	West Midlands
United Kingdom	St Mark's Hospital - North West London Hospitals Nhs Trust	Harrow	Middlesex
United Kingdom	Clinical Research Centre - Barts Health NHS Trust	London	E1 2at
United Kingdom	Clinical Research Centre - Barts Health NHS Trust	London	E1 2at
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust	London
United Kingdom	Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk
United States	Emory University Hospital, The Emory Clinic	Atlanta	Georgia
United States	Novel Research, LLC	Bellaire	Texas
United States	Tidewater Gastroenterology, P.L.L.C. d/b/a Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	West Central Gastroenterology, LLP, d/b/a/ Gastro Florida	Clearwater	Florida
United States	Baylor University Medical Center	Dallas	Texas
United States	Atlanta Center For Gastroenterology, P.C.	Decatur	Georgia
United States	Ohio Gastroenterology Group	Dublin	Ohio
United States	THR	Fort Worth	Texas
United States	VVCRD Clinical Research	Garden Grove	California
United States	DHAT Research Institute	Garland	Texas
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	Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	I.H.S Health, LLC	Kissimmee	Florida
United States	Auzmer Research, Combined Research Orlando Phase I-IV	Lakeland	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	BVL Clinical Research	Liberty	Missouri
United States	GastroIntestinal BioSciences	Los Angeles	California
United States	University Of Louisville	Louisville	Kentucky
United States	TDDC dba GI Alliance Research	Mansfield	Texas
United States	Tandem Clinical Research GI, LLC	Marrero	Louisiana
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Wellness Clinical Research	Miami Lakes	Florida
United States	United Medical Doctors	Murrieta	California
United States	GI PROS, Inc.	Naples	Florida
United States	Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)	New York	New York
United States	Rochester Clinical Research	New York	New York
United States	Weill Cornell Medical College of Cornell University	New York	New York
United States	DiGiovanna Institute for Medical Education and Research	North Massapequa	New York
United States	Hightower Clinical - SSM Health, Oklahoma University Health Sciences Center (OUHSC)	Oklahoma City	Oklahoma
United States	UCI Health	Orange	California
United States	Digestive Endoscopy Center NG-Gastroenterology Associates of Orangeburg	Orangeburg	South Carolina
United States	University Gastroenterology	Providence	Rhode Island
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	University of Washington Medical Center	Seattle	Washington
United States	USF Tampa General Hospital	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Victoria Gastroenterology	Victoria	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Romania,  Slovakia,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at 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).	Week 12
Secondary	Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12	Clinical remission is defined as a CDAI score of <150 points.	Week 12
Secondary	Percentage of Participants With a Clinical Response Based on the CDAI at Week 12	Clinical response is defined as =100-point decrease from Baseline in CDAI score.	Week 12
Secondary	Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.	Endoscopic remission as per SES-CD is defined as SES-CD score =4 or =2 for ileal disease, no subscore >1.	Week 12
Secondary	Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at 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.	Week 12
Secondary	Percentage of Participants With a Clinical Response in PRO2 at 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.	Week 12
Secondary	Percentage of Participants With no Bowel Urgency at 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.	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, 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.	Week 12
Secondary	Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at 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.	Baseline to Week 12
Secondary	Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at 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.	Baseline to Week 12

External Links

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