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

NCT06233461
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
268
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Lead sponsor
Takeda
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Start date
2024-03-05
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Number of sites
201
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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.
clinicaltrials.gov
Short title
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
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-07-23
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First posted
2024-01-31
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Registry last updated
2026-09-25
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Primary completion date
2027-02-17
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Start date
2024-03-05
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Participants
268
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Participant count basis
Estimated
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Planned participants
268
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Protocol amendments
3
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Randomisation ratio
1:1:1:1
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Number of sites
201
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Takeda
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06233461
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ClinicalTrials.gov ID
NCT06233461
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

    Timeframe: 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).

  1. Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12

    Timeframe: Week 12

    Clinical remission is defined as a CDAI score of \<150 points.

  2. Percentage of Participants With a Clinical Response Based on the CDAI at Week 12

    Timeframe: Week 12

    Clinical response is defined as \>=100-point decrease from Baseline in CDAI score.

  3. Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.

    Timeframe: Week 12

    Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1.

  4. Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12

    Timeframe: 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.

  5. Percentage of Participants With a Clinical Response in PRO2 at Week 12

    Timeframe: 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.

  6. Percentage of Participants With no Bowel Urgency at Week 12

    Timeframe: 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.

  7. Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12

    Timeframe: 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.

  8. Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12

    Timeframe: 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.

  9. 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

    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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • United Medical DoctorsMurrieta, United StatesRecruiting
  • UCI HealthOrange, United StatesRecruiting
  • West Central Gastroenterology, LLP, d/b/a/ Gastro FloridaClearwater, United StatesRecruiting
  • Auzmer ResearchLakeland, United StatesRecruiting
  • Wellness Clinical ResearchMiami Lakes, United StatesRecruiting
  • GI PROS, Inc.Naples, United StatesRecruiting
  • AdventHealth (Florida Hospital) Medical GroupOrlando, United StatesNot yet recruiting
  • USF Health Morsani Center for Advanced HealthcareTampa, United StatesRecruiting
  • Emory University Hospital, The Emory ClinicAtlanta, United StatesRecruiting
  • Atlanta Center For Gastroenterology, P.C.Decatur, United StatesRecruiting
  • The University of Iowa Hospitals & ClinicsIowa City, United StatesRecruiting
  • University of Kansas Medical CenterKansas City, United StatesRecruiting
  • University Of LouisvilleLouisville, United StatesRecruiting
  • Woodholme Gastroenterology AssociatesGlen Burnie, United StatesRecruiting
  • BVL Clinical ResearchLiberty, United StatesRecruiting
  • Las Vegas Medical ResearchLas Vegas, United StatesRecruiting
  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)New York, United StatesRecruiting
  • Rochester Clinical Research, IncRochester, United StatesNot yet recruiting
  • Great Lakes Gastroenterology Research, LLCMentor, United StatesRecruiting
  • Hightower Clinical - SSM HealthOklahoma City, United StatesCompleted
  • University Gastroenterology ProvidenceProvidence, United StatesRecruiting
  • Gastroenterology Associates, PAGreenville, United StatesRecruiting
  • Novel Research, LLCBellaire, United StatesRecruiting
  • TDDC - Baylor University Medical Center Gaston AveDallas, United StatesCompleted
  • Texas Digestive Disease Consultants, PLLC d/b/a GI AllianceFort Worth, United StatesCompleted

And 176 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • jRCT2051240050
  • 2023-506704-14-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)