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Clinical Trials/NCT05057273
NCT05057273
Withdrawn
Phase 2

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

NImmune Biopharma0 sitesNovember 2021
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ConditionsCrohn's Disease
InterventionsBT-11Active comparator
DrugsBT-11Active comparator

Overview

Phase
Phase 2
Intervention
BT-11
Conditions
Crohn's Disease
Sponsor
NImmune Biopharma
Primary Endpoint
Biomarkers of reponse
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

Registry
clinicaltrials.gov
Start Date
November 2021
End Date
February 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
NImmune Biopharma
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Male and female subjects age 18 to 75 years, inclusive.
  • •Diagnosis of CD for at least 6 weeks prior to screening
  • •Moderate to severely active CD as defined by all of the following:
  • •CDAI score of 220-450
  • •PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
  • •SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Exclusion Criteria

  • •Participant has ulcerative colitis
  • •Participant is at imminent risk of ileo-colectomy
  • •Prior enrolment in the current study and had received study treatment.

Arms & Interventions

BT-11 880 mg

Oral once daily tablet

Intervention: BT-11

Standard of care

Biologic

Intervention: Active comparator

Outcomes

Primary Outcomes

Biomarkers of reponse

Time Frame: 12 weeks

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