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NCT05057273 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05057273
Other study ID # BT-11-202B
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date November 2021
Est. completion date February 2022

Study information
Verified date June 2023
Source NImmune Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key 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

Related Conditions & MeSH terms

Intervention

Drug:
• BT-11
Oral once daily tablet
• Active comparator
Biologic

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NImmune Biopharma

Outcome
Type Measure Description Time frame Safety issue
Primary Biomarkers of reponse 12 weeks
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