What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as anti-TNF agents (e.g., infliximab, adalimumab) and other biologics, can have side effects including increased risk of infections, infusion reactions, and potential development of antibodies against the medication, which can reduce efficacy. Other side effects may include liver toxicity, heart failure, and rare instances of demyelinating diseases. Additionally, patients may experience gastrointestinal symptoms, headaches, and skin reactions. It is important to monitor for these side effects and manage them in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of moderate to severe Crohn's Disease. These include infliximab, adalimumab, and certolizumab pegol, which are anti-TNF agents that help reduce inflammation. Vedolizumab, an alpha-4-beta-7 integrin antibody, and ustekinumab, an IL-12 and IL-23 inhibitor, are also approved and have shown benefits in patients with Crohn's Disease. While these treatments primarily target inflammation, they may indirectly affect fibrotic strictures by reducing overall disease activity. However, specific anti-fibrotic agents like AGMB-129, which directly target intestinal strictures, are still under investigation.

What other types of research exist?

Promising novel alternatives to AGMB-129 for Crohn's Disease patients include: 1) Certolizumab pegol, a pegylated anti-TNF alpha agent, which has shown rapid and sustained remission in moderate to severe Crohn's Disease. 2) Janus kinase (JAK) inhibitors, which block immune cell communications and have shown efficacy in inflammatory bowel disease. 3) Sphingosine-1-phosphate receptor modulators, which block immune cell migration and are emerging as effective treatments for IBD. These alternatives offer new therapeutic strategies for managing Crohn's Disease, particularly for patients with fibrotic complications.

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AGMB-129 for Crohn's Disease

Phase 2

Recruiting

Research Sponsored by Agomab Spain S.L.

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 48

Summary

This trial is testing a new medication called AGMB-129 to help people with Crohn's disease who have painful narrowings in their intestines. The goal is to see if this medication can safely widen these narrowings and reduce symptoms like pain and vomiting, potentially avoiding the need for surgery.

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.

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.

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 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with abnormal 2D-echocardiography (Part A and B)

Number of participants with abnormal ECG parameters (Part A and B)

Number of participants with abnormal clinical laboratory values (Part A and B)

+3 more

Secondary study objectives

Changes in mRNA gene expression in ileal biopsies ((Part A)

Plasma levels of AGMB-129 and its metabolites (Part A and B)

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

2024

Completed Phase 1

~40

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease primarily target inflammation and immune response. Anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol work by inhibiting TNF-α, a cytokine that plays a significant role in promoting inflammation. These treatments help reduce inflammation, induce and maintain remission, and heal fistulas. Additionally, potential anti-fibrotic agents like AGMB-129 are being studied for their ability to alleviate fibrotic strictures in the intestines, which can cause obstructive symptoms. Understanding these mechanisms is important for patients as it highlights how these therapies can manage symptoms, prevent complications, and improve overall disease outcomes.