MedDataX Logo

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

NCT ID: NCT03870334

Last Updated: 2023-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BT-11 880 mg

Oral once daily tablet

Group Type EXPERIMENTAL

BT-11 880 mg

Intervention Type DRUG

Oral once daily tablet

Placebo

Oral once daily tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral once daily tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BT-11 880 mg

Oral once daily tablet

Intervention Type DRUG

Placebo

Oral once daily tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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);

Exclusion Criteria

1. Ulcerative colitis;
2. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NImmune Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Study Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria Poland United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BT-11-202

Identifier Type: -

Identifier Source: org_study_id