A Phase 2b, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial to Assess the Efficacy and Safety of Ontunisertib in Patients with Fibrostenosing Crohn’s Disease

Conditions

Fibrostenosing Crohn’s Disease

Brief summary

Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 24

Detailed description

01 Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52, 02 Change from baseline in MRE-based reliable imaging features of index stricture at Week 24 and Week 52, 03 Change from baseline in total SES-CD at Week 24 and Week 52, 04 Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1) at Week 24 and Week 52 compared to baseline, 05 Change from baseline in S-PRO severity score at Week 24 and Week 52, 06 Time to an FSCD-related event, 07 Safety as assessed by TEAEs, clinical laboratory, vital signs, ECG, and physical examinations, 08 Concentration of ontunisertib and metabolites in plasma

Related papers

No related papers found yet.

Interventions

DRUGOntunisertib

DRUGPlacebo to IMP ontunisertib

DRUGcapsule

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 24	—

Secondary

Measure	Time frame
01 Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52, 02 Change from baseline in MRE-based reliable imaging features of index stricture at Week 24 and Week 52, 03 Change from baseline in total SES-CD at Week 24 and Week 52, 04 Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1) at Week 24 and Week 52 compared to baseline, 05 Change from baseline in S-PRO severity score at Week 24 and Week 52, 06 Time to an FSCD-related event, 07 Safety as assessed by TEAEs, clinical laboratory, vital signs, ECG, and physical examinations, 08 Concentration of ontunisertib and metabolites in plasma	—

Measure

Time frame

01 Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52, 02 Change from baseline in MRE-based reliable imaging features of index stricture at Week 24 and Week 52, 03 Change from baseline in total SES-CD at Week 24 and Week 52, 04 Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1) at Week 24 and Week 52 compared to baseline, 05 Change from baseline in S-PRO severity score at Week 24 and Week 52, 06 Time to an FSCD-related event, 07 Safety as assessed by TEAEs, clinical laboratory, vital signs, ECG, and physical examinations, 08 Concentration of ontunisertib and metabolites in plasma

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Outcome results

None listed