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Anti-inflammatory

TAK-279 Dose 2 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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Secondary outcome measures
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 more

Trial 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 as per investigator's discretion.
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 as per investigator's discretion.
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 as per investigator's discretion.
Group IV: PlaceboExperimental Treatment1 Intervention
Participants will be randomized to receive TAK-279 placebo-matching capsules orally as per investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~180
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,676 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,004 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 65 eligible to participate in this clinical trial?

"Eligible participants for this research study must be over 18 years old but under the age of 75."

Answered by AI

Is the enrollment process open for this medical study at present?

"Yes, information available on clinicaltrials.gov confirms that this investigation is currently seeking eligible participants. The trial was initially shared on the platform on March 5th, 2024, with the most recent update dated April 2nd, 2024. Recruitment aims to enroll a total of 268 individuals across ten designated sites."

Answered by AI

What is the current participation count in this clinical trial?

"Indeed, the current information on clinicaltrials.gov confirms that patient recruitment is ongoing for this investigation. The study was first listed on March 5th, 2024 and last updated on April 2nd of the same year. A total of 268 participants are sought from ten different sites."

Answered by AI

Which individuals meet the criteria for eligibility to take part in this clinical study?

"This medical trial is enrolling 268 individuals aged between 18 and 75 who are presently managing Crohn's disease. Eligible participants must adhere to the subsequent requirements: Male or female within the age range of 18-75 years with a confirmed diagnosis of CD for a minimum duration of 30 days., The presence of moderately to severely active CD as determined by SES-CD and CDAI is mandatory., Individuals should have experienced an insufficient response, loss of efficacy, or intolerance to at least one standard or biological treatment for CD., Compliance with contraception guidelines is also imperative."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"Patients are currently being enrolled at United Medical Doctors in Murrieta, California; GI PROS, Inc. in Naples, Florida; and West Central Gastroenterology, LLP (Gastro Florida) in Clearwater, New york. Additionally, recruitment is ongoing at 10 other undisclosed sites."

Answered by AI

Has the second dosage of TAK-279 been sanctioned by the FDA?

"The safety assessment for TAK-279 Dose 2 is rated at 2 by our team, based on the Phase 2 trial status. This indicates existing data supporting safety but lacking evidence of efficacy."

Answered by AI
~179 spots leftby Sep 2026