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Study on the Safety and Effects of ORG-129 in Patients with Fibrostenotic Crohn's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for fibrostenotic Crohn's disease, a condition where parts of the digestive system become narrowed due to inflammation and scarring. The treatment being tested is a medication called AGMB-129, which is taken in capsule form. The study will compare the effects of AGMB-129 to a placebo to understand its safety and how it works in the body.

The purpose of the study is to evaluate the safety and tolerability of AGMB-129 in patients with fibrostenotic Crohn's disease. Participants will be randomly assigned to receive either AGMB-129 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ups to monitor the participants' health and any changes in their condition.

Throughout the study, various health assessments will be conducted, including checking for any side effects, performing clinical laboratory tests, and monitoring heart health through an electrocardiogram (ECG). The study will also look at how AGMB-129 is processed in the body and its effects on certain genes in the intestinal lining. The goal is to gather comprehensive information about the treatment's safety and its potential benefits for people with fibrostenotic Crohn's disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current symptoms related to fibrostenotic Crohn's disease.
Eligibility is based on specific criteria, such as having a diagnosis of Crohn's disease with at least one stricture in the terminal ileum and stable symptoms.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the investigational medication AGMB-129 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The medication is provided in capsule form and is taken orally.
Step 3
Treatment period (part a)
The treatment period lasts for 12 weeks. During this time, participants take the assigned medication daily.
Regular monitoring is conducted to assess safety and any potential side effects. This includes clinical laboratory tests, electrocardiograms (ECGs), and physical examinations.
Step 4
Evaluation at week 12
At the end of the 12-week treatment period, a comprehensive evaluation is performed. This includes assessing any adverse events, changes in vital signs, and other health indicators.
Participants' responses to the treatment are also evaluated through various tests, including a 2-D echocardiogram.
Step 5
Continuation of treatment (part b)
Participants who complete the initial 12-week period and are eligible may continue treatment in Part B of the study.
Continuation is based on the investigator's judgment and the participant's willingness to proceed.
Step 6
Ongoing monitoring
Throughout the study, ongoing monitoring is conducted to ensure participant safety and to gather data on the effects of AGMB-129.
This includes tracking pharmacokinetic parameters, which involve how the drug is absorbed, distributed, metabolized, and excreted by the body.

Who can join the trial?

8 criteria

Must have a diagnosis of **ileal** or **ileocolonic Crohn's Disease**. This means the disease affects the last part of the small intestine or both the small and large intestines. The diagnosis should be based on medical guidelines and confirmed at least 3 months before joining the study.
Must have at least one **stricture** in the **terminal ileum**. A stricture is a narrowing of the intestine. It should be confirmed by a special scan called **MRE**. The stricture should not be too severe and should be caused by Crohn's Disease.
Must have **obstructive symptoms** that are manageable. This means symptoms like blockage in the intestine should not be severe enough to need hospital treatment or surgery. The person should be able to eat enough food, even if they need to change their diet, and maintain a stable weight for 4 weeks before joining the study.
Must be on a stable treatment plan for Crohn's Disease and agree to continue this treatment during the study.
For Part B of the study: Must have completed the 12-week treatment period in Part A and be willing and able to continue treatment.
For Part B of the study: The doctor must believe the participant can continue or restart treatment after finishing Part A.
Participants can be of any gender.
Participants must be within the age range specified by the study.

Who cannot join the trial?

5 criteria

Patients who do not have **fibrostenotic Crohn's disease**. This is a type of Crohn's disease where the intestines become narrowed due to thickening of the walls.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aarhus University Hospital
Verified
Aarhus, Denmark
Bispebjerg Hospital
Verified
Copenhagen, Denmark
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain

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Investigated drugs

AGMB-129 is a medication being studied for its effects on patients with fibrostenotic Crohn's disease. This condition involves inflammation and scarring in the intestines, which can lead to narrowing and blockages. The trial aims to understand how safe and tolerable AGMB-129 is for patients, as well as how the body processes and responds to the medication.

ORG-129

What is already known about the treatment

AGMB-129 – AGMB-129 is administered orally and is currently being studied in clinical trials for its potential use in treating fibrostenotic Crohn's disease. This medication is in the investigational stage, with ongoing research to determine its safety and effectiveness. The main therapeutic indication for AGMB-129 is to manage fibrostenotic Crohn's disease, a condition characterized by inflammation and narrowing of the intestines. At the molecular level, AGMB-129 is believed to work by modulating specific pathways involved in inflammation and fibrosis, although the exact mechanism is still under investigation. It is classified pharmacologically as an anti-inflammatory agent, with a focus on reducing intestinal fibrosis and improving bowel function.

Investigated diseases

Fibrostenotic Crohn's Disease – This is a form of Crohn's disease characterized by the thickening and narrowing of the intestinal walls due to fibrosis and scarring. It primarily affects the digestive tract, leading to symptoms such as abdominal pain, cramping, and bowel obstruction. Over time, the fibrotic tissue can cause strictures, which are narrowings in the intestines that can impede the passage of food. This condition can lead to complications like bowel blockages and may require surgical intervention to relieve the strictures. The progression of fibrostenotic Crohn's disease can vary, with periods of flare-ups and remission. It is a chronic condition that requires ongoing management to control symptoms and prevent complications.