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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 from baseline to week 12
Awards & highlights
Study Summary
This trial is testing a drug to see if it's safe and effective to treat Crohn's disease. Participants will be monitored for up to 19 weeks. #ClinicalTrial #CrohnsDisease
Who is the study for?
This trial is for people with Crohn's Disease who have a narrowed intestinal section and up to two non-critical strictures in the ileum, confirmed by imaging. They should be experiencing manageable symptoms without needing hospitalization or surgery during the study and must maintain their current Crohn's medication.Check my eligibility
What is being tested?
AGMB-129 is being tested against a placebo to see if it's safe for patients with fibrostenotic Crohn's Disease, how the body processes it (pharmacokinetics), and what effects it has on the body (pharmacodynamics). Participants will receive either a high or low dose of AGMB-129 or a placebo over 12 weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, this trial aims to determine how well patients tolerate AGMB-129 and any adverse reactions they might experience compared to those taking a placebo.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with abnormal 2D-echocardiography
Number of participants with abnormal ECG parameters
Number of participants with abnormal clinical laboratory values
+3 moreSecondary outcome measures
Changes in mRNA gene expression in ileal biopsies
Plasma levels of AGMB-129 and its metabolites
Trial Design
3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Matching placebo
Group II: AGMB-129 LowExperimental Treatment1 Intervention
AGMB-129 low dose
Group III: AGMB-129 HighExperimental Treatment1 Intervention
AGMB-129 high dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGMB-129
2023
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Agomab Spain S.L.Lead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Philippe Wiesel, MDStudy DirectorAgomab Therapeutics
4 Previous Clinical Trials
401 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to keep taking certain medications that affect my whole body.I have or had a blood vessel or heart valve disorder.I am on a stable treatment plan for Crohn's disease and agree to keep it the same during the study.My symptoms are manageable and I'm not expected to need hospital care or surgery during the study.I am currently taking specific medications.I have a history or current diagnosis of a specific type of colitis.I was diagnosed with Crohn's disease in my ileum or ileocolon at least 3 months ago.I have not had a balloon dilation or surgery for a small bowel blockage in the last 6 months.My inflammation in the small intestine is not due to Crohn's disease.I have had surgery or complications related to Crohn's disease.I have up to 2 blockages in my small intestine due to Crohn's disease, and at least one is reachable for a camera test.
Research Study Groups:
This trial has the following groups:- Group 1: AGMB-129 High
- Group 2: AGMB-129 Low
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the scope of this experiment in terms of subject numbers?
"Affirmative. According to clinicaltrials.gov, this research is enrolling participants from its first post on August 1st 2023 up until the most recent update of 8/9/2023. The study requires 36 patients at one medical site for completion."
Answered by AI
Is enrollment for this study still open to participants?
"Affirmative. Clinicaltrials.gov records that this clinical test, which was initially presented on August 1st 2023, is currently enrolling participants. 36 patients are required to be gathered from a single medical centre."
Answered by AI
Has AGMB-129 been endorsed by the FDA?
"While there is minimal evidence for AGMB-129 High's efficacy, its safety has been verified to a satisfactory degree; thus it receives an assessment of 2."
Answered by AI
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