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NCT03870334 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03870334
Other study ID # BT-11-202
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 5, 2021
Est. completion date August 26, 2022

Study information
Verified date November 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, placebo-controlled, double-blind, parallel-group multicenter induction study.

Recruitment information / eligibility
Status Terminated
Enrollment 27
Est. completion date August 26, 2022
Est. primary completion date August 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: 1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months; 2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored = 6 ( = 4 for isolated ileitis) (centrally read); Key exclusion criteria: 1. Ulcerative colitis; 2. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BT-11 880 mg
Oral once daily tablet
• Placebo
Oral once daily tablet

Locations
Country Name City State
United States Study Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
NImmune Biopharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Remission Rate Clinical remission defined by CDAI score <150. 12 weeks
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