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

Phase 2TerminatedNCT03870334

NImmune Biopharma27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Crohn's Disease

Interventions

BT-11 880 mgDRUG

Oral once daily tablet

PlaceboDRUG

Oral once daily tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Study Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Clinical Remission Rate

Clinical remission defined by CDAI score \<150.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.