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Anti-inflammatory
TAK-279 for Crohn's Disease
Phase 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Summary
This trial is looking at a new drug called TAK-279 to see if it is effective and safe in treating Crohn's disease. They will compare three different doses of TAK-279 to
Who is the study for?
This trial is for adults aged 18-75 with Crohn's Disease that's active and moderate to severe. They should have tried other treatments without success or couldn't tolerate them. Participants must follow specific contraception advice.
What is being tested?
The study tests TAK-279, a potential new treatment for reducing bowel inflammation in Crohn's Disease, against a placebo over one year. It aims to see if different doses of TAK-279 are effective and safe after 12 weeks using endoscopy.
What are the potential side effects?
Possible side effects of TAK-279 aren't specified but generally may include reactions at the injection site, gastrointestinal symptoms, increased risk of infection, or other immune-related conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Secondary study objectives
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: TAK-279 Dose 3Experimental Treatment1 Intervention
Participants will be randomized to receive TAK-279 Dose 3 capsules orally.
Group II: TAK-279 Dose 2Experimental Treatment2 Interventions
Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
Group III: TAK-279 Dose 1Experimental Treatment2 Interventions
Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
Group IV: PlaceboExperimental Treatment1 Intervention
Participants will be randomized to receive TAK-279 placebo-matching capsules orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~390
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,240 Previous Clinical Trials
4,149,203 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,288 Previous Clinical Trials
501,484 Total Patients Enrolled