AGMB-129 for Crohn's Disease

Not currently recruiting at 60 trial locations

Overseen By Tim Van Kaem

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Agomab Spain S.L.U.

Must not be taking: Cyclosporine, Tacrolimus, Sirolimus, others

Disqualifiers: Ulcerative colitis, Short bowel syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AGMB-129 for individuals with Crohn's disease who have strictures (narrowing) in their intestines. These strictures can cause painful blockages and other symptoms that might require surgery. The study aims to determine if AGMB-129 can safely alleviate these symptoms and improve the condition of the strictures. It suits those with Crohn's disease who have at least one intestinal narrowing and experience symptoms like abdominal pain or cramping after meals. Participants will receive either a high dose, low dose, or placebo (inactive substance) to compare effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial requires that you maintain your current Crohn's disease medications throughout the study. However, you cannot be on certain medications like cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of screening, or Janus kinase inhibitors within 4 weeks of screening.

Is there any evidence suggesting that AGMB-129 is likely to be safe for humans?

Research shows that AGMB-129 has undergone safety testing in healthy individuals. Studies found that a single dose up to 1200 mg and multiple doses up to 200 mg twice daily for 10 days were safe. No major safety issues or severe side effects emerged, and no toxic effects limited the dosage. These findings indicate that AGMB-129 was well-tolerated in early tests. However, its safety and effectiveness for treating Crohn's disease remain under investigation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

AGMB-129 is unique because it offers a new approach to treating Crohn's disease, potentially setting it apart from current standards like corticosteroids, immunosuppressants, and biologics. Researchers are excited about AGMB-129 because it targets specific pathways involved in inflammation more directly, which could mean better precision in reducing symptoms. Unlike traditional treatments, which often have broad effects and can take time to work, AGMB-129 might offer faster relief with potentially fewer side effects. Additionally, the trial is exploring both high and low doses, which could provide more personalized treatment options.

What evidence suggests that AGMB-129 might be an effective treatment for Crohn's disease?

Research has shown that AGMB-129 might help people with Crohn's disease who have intestinal narrowings. In earlier studies, participants generally tolerated AGMB-129 well, experiencing no major side effects. The drug works effectively in the gut, where it's needed. Early results suggest that AGMB-129 could reduce the need for surgery by easing symptoms like belly pain and cramping. While more research is needed, these initial findings offer hope for those with intestinal narrowings due to Crohn's disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Philippe Wiesel, MD

Principal Investigator

Agomab Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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 was diagnosed with Crohn's disease in my ileum or ileocolon at least 3 months ago.

Exclusion Criteria

I have or had a blood vessel or heart valve disorder.

I need to keep taking certain medications that affect my whole body.

I am currently taking specific medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

1 visit (in-person)

Treatment

Participants receive AGMB-129 or placebo for 12 weeks in a double-blind, placebo-controlled setting

12 weeks

4 visits (in-person) at Weeks 2, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Open-label extension

Participants may opt into continuation of treatment with AGMB-129 for up to 48 weeks

48 weeks

Regular visits throughout the extension period

Follow-up after extension

Participants are monitored for safety after the open-label extension

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AGMB-129
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Matching placebo

Group II: AGMB-129 Low Experimental Treatment 1 Intervention

AGMB-129 low dose

Group III: AGMB-129 High Experimental Treatment 1 Intervention

AGMB-129 high dose

AGMB-129 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as AGMB-129 for:

• Fibrostenosing Crohn's Disease (Fast Track Designation)

Approved in European Union as AGMB-129 for:

• Fibrostenosing Crohn's Disease (under investigation)

Approved in Canada as AGMB-129 for:

• Fibrostenosing Crohn's Disease (under investigation)

Who Is Running the Clinical Trial?

Agomab Spain S.L.U.

Lead Sponsor

Agomab Spain S.L.

Lead Sponsor

Trials

4

Recruited

210+

Published Research Related to This Trial

In a study involving 260 participants (130 Crohn's disease patients and 130 healthy controls), no Mycobacterium avium subspecies paratuberculosis (MAP) was found in the blood of either group, suggesting that MAP may not be a direct cause of Crohn's disease.

Crohn's disease patients had a higher frequency of polymorphisms in the NOD2/CARD15 gene compared to healthy controls, indicating a potential genetic predisposition to the disease, but no link was found between these genetic variations and the presence of MAP in the blood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absence of mycobacterium avium subsp. paratuberculosis in Crohn's patients. Parrish, NM., Radcliff, RP., Brey, BJ., et al.[2018]

Anti-granulocyte macrophage-colony stimulating factor autoantibodies (aGMAbs) can be detected in patients with Crohn's disease years before diagnosis, indicating their potential as predictive biomarkers for complicated cases of the disease.

These aGMAbs specifically target altered glycosylation patterns on GM-CSF, which disrupts immune balance and promotes certain immune cell types, suggesting a mechanism by which they contribute to the pathogenesis of Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neutralizing Anti-Granulocyte Macrophage-Colony Stimulating Factor Autoantibodies Recognize Post-Translational Glycosylations on Granulocyte Macrophage-Colony Stimulating Factor Years Before Diagnosis and Predict Complicated Crohn's Disease. Mortha, A., Remark, R., Del Valle, DM., et al.[2023]

In a study of 231 Israeli patients with Crohn's disease, the 3'-UTR SNP of the NFKBIA gene did not show a significant association with disease characteristics or susceptibility compared to 100 healthy controls.

The research highlights the complexity of genetic factors in Crohn's disease, indicating that population diversity may influence the role of susceptibility genes, but NFKBIA alone does not appear to affect disease onset or behavior in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of association of the 3'-UTR polymorphism in the NFKBIA gene with Crohn's disease in an Israeli cohort. Leshinsky-Silver, E., Karban, A., Cohen, S., et al.[2020]

The study found that the NFKBIA 2758G/A and ICAM-1 K469E gene variants are not significant risk factors for Crohn's disease in a New Zealand population, based on an analysis of 182 patients and 188 controls.

However, the ICAM-1 K469E variant was associated with influencing the age of diagnosis for Crohn's disease, suggesting it may have a role in the disease's progression rather than its susceptibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polymorphisms in NFKBIA and ICAM-1 genes in New Zealand Caucasian Crohn's disease patients. Hong, J., Leung, E., Fraser, AG., et al.[2022]

In a study of 273 patients with inflammatory bowel disease, pancreatic juice antibodies (PAB) were found in 31% of patients with Crohn's disease, making it a potential specific serological marker for this condition.

The presence of PAB did not correlate with disease activity or treatment response, indicating that while PAB may be specific to Crohn's disease, their role in disease pathogenesis remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibodies to a trypsin sensitive pancreatic antigen in chronic inflammatory bowel disease: specific markers for a subgroup of patients with Crohn's disease. Seibold, F., Weber, P., Jenss, H., et al.[2019]

Citations

1. agomab.com agomab.com/wp-content/uploads/2025/05/20250507_AGMB-129-DDW-presentation_Final.pdf

Late-Breaking Interim STENOVA Data Presented at ... 2025 Demonstrate Potential of AGMB-129 in Fibrostenosing Crohn's Disease ... The PK data indicated very low systemic exposure to AGMB-129.

2. agomab.com agomab.com/wp-content/uploads/2025/03/20250310_AGMB-129-topline-interim-STENOVA_FINAL.pdf

Agomab Announces Positive Topline Phase 2a Interim ... subjects, single- and multiple-dose AGMB-129 was generally well-tolerated at all doses tested. In addition, the trial showed high local ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07118878

A Multiple Ascending Dose Study With AGMB-129 in ... AGMB-129 has shown to be safe in healthy participants with single doses up to 1200 mg and multiple doses up to 200 mg twice daily (BID) for 10 days, and in ...

4. thelancet.com thelancet.com/pdfs/journals/langas/PIIS2468-1253(25)00167-0.pdf

Digestive Disease Week 2025 At the interim analysis of. 44 participants, AGMB-129 was safe and well tolerated at both doses, with adverse events similar across groups. Two ...

5. touchimmunology.com touchimmunology.com/inflammatory-bowel-disease/conference-hub/the-stenova-trial-a-first-in-class-first-in-indication-study-of-agmb-129-in-fibrostenotic-crohns-disease-florian-rieder-ddw-2025/

The STENOVA Trial, a First-in-Class, First-in-Indication ... The primary endpoint was safety and tolerability, and AGMB-129 is safe and well tolerated in patients with fibrous stenosis and Crohn's disease.

6. agomab.com agomab.com/agmb-129/

Ontunisertib (AGMB-129) No drug-related safety signal or dose-limiting toxicities were identified. In addition, the trial showed high local exposure to ontunisertib in the ileum but no ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20559625

A Study to Evaluate Safety, Tolerability, PK and PD of ... The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics of AGMB-129 in patients with Crohn's disease ...

8. agomab.com agomab.com/

Agomab Therapeutics – Restoring Organ Function Late-Breaking Interim STENOVA Data for AGMB-129 in Fibrostenosing Crohn's to be Presented at Digestive Disease Week® 2025. Antwerp, Belgium, April 10, 2025