Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT07683325 Sponsor: Agomab Spain S.L.U. Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT07683325
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with Crohn's disease (CD) affecting the small intestine (ileum) or both the small intestine and colon, confirmed by camera examination or imaging, with that diagnosis made at least 12 weeks before signing the consent form.
  • People who have at least one narrowing (stricture) in the small intestine that is too tight for a camera scope to pass through.
  • People whose narrowing(s) may be in the original bowel or at a surgical join site, and will be confirmed by a special type of MRI scan reviewed by a central team.
  • People who are experiencing symptoms of partial or full blockage and/or have had to restrict how much they eat, what types of food they eat, or how their food is prepared.
  • People who are currently on a stable anti-inflammatory treatment for Crohn's disease and are willing to keep that treatment unchanged for the full duration of the trial.
  • People whose body mass index (a measure of weight relative to height) falls between 18 and 35.
  • People who, in the treating doctor's opinion, are not expected to need hospitalisation, a procedure to stretch the narrowing, bowel surgery, or changes to their anti-inflammatory treatment within the first 4 weeks of the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have, or have previously had, other types of bowel inflammation or conditions such as ulcerative colitis, indeterminate colitis, colitis caused by reduced blood flow, colitis caused by anti-inflammatory pain medications, colitis without a clear cause, radiation-related colitis, microscopic colitis, abnormal cell changes in the bowel lining, untreated problems absorbing bile acid, or infectious colitis.
  • People who have short bowel syndrome, meaning less than 200 cm of small intestine remaining after surgery.
  • People who have a surgically created opening from the bowel to the abdomen wall (such as an ileostomy, colostomy, small bowel stoma, or an internal pouch after bowel removal).
  • People who have internal tunnels or channels (fistulae or sinus tracts) coming from the area of the narrowing, though people with fistulae near the back passage may still be considered if there is no infection present.
  • People who have a narrowing in or around the back passage (anal or perianal stricture).
  • People who have a suspected or confirmed pocket of infection (abscess) in the abdomen or near the back passage that has not been properly treated, particularly if it is connected to the bowel narrowing.
  • People who have toxic megacolon (a severe and dangerous enlargement of the colon).
  • People who have had a procedure to stretch their small bowel narrowing using a balloon, or surgery on that narrowing, within the 6 months before the screening visit.
  • People who have a current or past diagnosis of heart valve disease, or a moderate to severe problem with how a heart valve opens or closes, or a heart pumping function below 50% as measured by an echocardiogram (heart ultrasound).
  • People who have any other serious ongoing or acute medical condition, mental health condition, abnormal test results, or active infection that the investigator believes could increase the risks of trial participation or affect the reliability of the trial results.
  • People who have significantly abnormal vital signs (such as heart rate or blood pressure), physical examination findings, or heart tracing (ECG) results at the screening or baseline visit.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Contact this trial

Principal Investigator: Silke Hüttner, MD, Agomab Therapeutics

Phone: 0032 3318 91 70

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Agomab Spain S.L.U.
Registry
ClinicalTrials.gov
Start date
30 October 2026
Est. completion
31 December 2028

Primary endpoints

Proportion of participants achieving endoscopic passability of the ileal index stricture

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov