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Status:

COMPLETED

Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Lead Sponsor:

NImmune Biopharma

Conditions:

Ulcerative Colitis

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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 effica...

Eligibility Criteria

Inclusion

  • Key
  • . 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.
  • Key

Exclusion

  • . 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.

Key Trial Info

Start Date :

August 14 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 17 2021

Estimated Enrollment :

198 Patients enrolled

Trial Details

Trial ID

NCT03861143

Start Date

August 14 2019

End Date

June 17 2021

Last Update

June 29 2023

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

Axis Clinical Trials

Los Angeles, California, United States, 90036

2

Ventura Clinical Trials

Ventura, California, United States, 93003

3

Clinical Research of California

Walnut Creek, California, United States, 94598

4

Medycal Research Inc.

Brooksville, Florida, United States, 34613