ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with Crohn's disease who develop symptomatic intestinal strictures currently often need endoscopic dilation or surgery. This trial tests an investigational oral drug (ontunisertib) aiming to improve stricture-related passability and reduce the need for procedural interventions.
Who Should Pay Attention
Adults with fibrostenosing Crohn's disease; gastroenterologists and surgeons managing strictures; IBD researchers and clinical trialists.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2
Enrollment320 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a Phase 2b randomized, double-blind, placebo-controlled trial testing ontunisertib (AGMB-129) versus placebo in adults with fibrostenosing Crohn's disease (FSCD) and symptomatic ileal or ileocolonic strictures.
Participants are randomized to high, medium, low dose, or placebo and followed for 52 weeks of treatment with endoscopic and radiologic assessments at screening, week 24, and week 52.
Key study procedures include ileocolonoscopy with biopsy and centrally read magnetic resonance enterography (MRE) to confirm and assess strictures, regular blood draws for safety and pharmacokinetics/pharmacodynamics, and routine safety monitoring (labs, ECG, vital signs).
The primary registered outcome is the proportion achieving endoscopic passability of the ileal index stricture at week 24.
Keep In Mind
This ClinicalTrials.gov record describes the study design and planned assessments but does not contain efficacy or safety results. Ontunisertib (AGMB-129) is investigational in this indication. Participants must meet detailed inclusion/exclusion criteria and continue stable background anti-inflammatory therapy during the trial.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorAgomab Spain S.L.U.
Trial IDNCT07683325
Study typeInterventional
Trial phasePhase 2
Enrollment320 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 24, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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