A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

NImmune Biopharma16 sites in 5 countries198 target enrollmentAugust 14, 2019

ConditionsUlcerative Colitis

InterventionsBT-11 (440 mg)BT-11 (880 mg)Placebo

DrugsBT-11 (880 mg)BT-11 (440 mg)Placebo

Overview

Phase: Phase 2
Intervention: BT-11 (440 mg)
Conditions: Ulcerative Colitis
Sponsor: NImmune Biopharma
Enrollment: 198
Locations: 16
Primary Endpoint: Clinical Remission
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 14, 2019

End Date

June 17, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NImmune Biopharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•. Male and female subjects aged 18 to 75 years, inclusive.
•. Diagnosis of UC for at least 3 months prior to screening.
•. UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
•. Able to participate fully in all aspects of this clinical trial.
•. Written informed consent must be obtained and documented.

Exclusion Criteria

•. A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
•. Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse \> 90 bpm, temperature \> 37.8°C, hemoglobin \< 10.5 g/dl, or hs-CRP \> 30 mg/I).
•. Disease activity limited to distal 15 cm (proctitis).
•. Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-MP\]) within 25 days prior to randomization.
•. Unable to attend study visits or comply with procedures.
•. Concurrent participation in any other interventional study.
•. Prior enrollment in the current study and had received study treatment.

Arms & Interventions

BT-11 low-dose (440 mg)

Oral, once daily tablet

Intervention: BT-11 (440 mg)

BT-11 high-dose (880 mg)

Oral, once daily tablet

Intervention: BT-11 (880 mg)

Placebo

Oral, once daily tablet

Intervention: Placebo

Outcomes

Primary Outcomes

Clinical Remission

Time Frame: Week 12

Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.