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Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

NCT03861143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2023-06-29

Study results available
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Summary

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

Conditions

Interventions

DRUG

BT-11 (440 mg)

Oral, once daily tablet

DRUG

BT-11 (880 mg)

Oral, once daily tablet

DRUG

Placebo

Oral, once daily tablet

Sponsors & Collaborators

  • NImmune Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2020-12-10
Completion
2021-06-17
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Croatia
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861143 on ClinicalTrials.gov