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NCT07683325

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 4 → 11 locations
  2. Study sites: 4 to 5
  3. Study sites: 3 to 4
  4. Eligibility criteria expanded, about 20 words
    • Study sites: 2 to 3
    • Secondary endpoints: details revised at 2 of 12 entries
  5. Study sites: 1 to 2v3
  6. Recruitment opened
    • Study sites: 0 to 1
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of participants achieving endoscopic passability of the ileal index stricture
Timeframe: At week 24

Secondary (12)

Proportion of participants achieving endoscopic passability of the ileal index stricture
Change in reliable MRE imaging features (stricture length, bowel wall thickness, prestenotic dilatation diameter) of the index stricture
Change in total SES-CD (range, 0-56 points) (Reference: https://www.giejournal.org/article/S0016-5107(04)01878-4/abstract)
Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1)
Change in S-PRO severity score
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Time to an FSCD- related event
Number of participants with adverse events (AEs)
Number of participants with abnormal clinical laboratory tests
Number of participants with abnormal ECG parameters
Number of participants with abnormal vital signs
Number of participants with abnormal physical examinations
Plasma level concentration of ontunisertib and metabolites

Arms and interventions

Ontunisertib HighExperimental

Ontunisertib high dose

Ontunisertib MediumExperimental

Ontunisertib medium dose

Ontunisertib LowExperimental

Ontunisertib low dose

PlaceboExperimental

Matching placebo

Drugs: Ontunisertib, Placebo

Sites

11 sites in 3 countries

United States 7, Serbia 3, United Kingdom 1