Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

June 6, 2023 updated by: NImmune Biopharma

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A total of 36 subjects with active eosinophilic esophagitis (≥ 15 eosinophils/HPF; SDI PRO ≥ 5) will be randomized in a 1:1:1 ratio to receive BT-11 500 mg twice daily, BT-11 1000 mg once daily, or placebo. Each of the treatment arms will comprise 12 subjects. The randomization will be stratified by ongoing PPI use at baseline (yes/no) and prior corticosteroid use (yes/no).

The study will consist of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period. A final analysis will be conducted after all subjects have reached Week 12.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

No patients enrolled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral
Drug: Placebo
Oral
Experimental: BT-11 low
Oral
Drug: BT-11 low
Oral
Experimental: BT-11 high
Oral
Drug: BT-11 high
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of AEs
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NImmune Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2022

Primary Completion (Estimated)

April 30, 2022

Study Completion (Estimated)

June 30, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-11-EoE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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