Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

Phase 2

Withdrawn

• Conditions: Crohn's Disease
• Interventions: Drug: BT-11; Drug: Active comparator

• Registration Number: NCT05057273
• Lead Sponsor: NImmune Biopharma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Study Start: 2021-11
• Primary Completion: 2022-02
• Study Completion: 2022-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male and female subjects age 18 to 75 years, inclusive.

2. Diagnosis of CD for at least 6 weeks prior to screening

3. 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

Key

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BT-11 880 mg	BT-11	Oral once daily tablet
Standard of care	Active comparator	Biologic

Primary Outcome Measures

Name	Time	Method
Biomarkers of reponse	12 weeks