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

NCT03870334 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BT-11-202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Clinical Remission Rate

  Clinical remission defined by CDAI score \<150.

  12 weeks

Study Arms (2)

BT-11 880 mg

EXPERIMENTAL

Oral once daily tablet

Drug: BT-11 880 mg

Placebo

PLACEBO COMPARATOR

Oral once daily tablet

Drug: Placebo

Interventions

BT-11 880 mg DRUG

Oral once daily tablet

BT-11 880 mg

Placebo DRUG

Oral once daily tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
• 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);

You may not qualify if:

• Ulcerative colitis;
• Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

Sponsors & Collaborators

• NImmune Biopharma: lead

Study Sites (1)

Study Center

Tampa, Florida, 33592, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Project Management
• Organization: NImmune

pm@nimmun.com

(540) 944-4545

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: May 5, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: December 4, 2023
• Results First Posted: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)