NCT03870334

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: NImmune Biopharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	BT-11 880 mg	Oral once daily tablet
DRUG	Placebo	Oral once daily tablet

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2019-03-12
• Last updated: 2023-12-04
• Results posted: 2023-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study