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

NCT ID: NCT04835168

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BT-11 low

Oral

Group Type EXPERIMENTAL

BT-11 low

Intervention Type DRUG

Oral

BT-11 high

Oral

Group Type EXPERIMENTAL

BT-11 high

Intervention Type DRUG

Oral

Placebo

Oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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BT-11 low

Oral

Intervention Type DRUG

BT-11 high

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

No patients enrolled
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NImmune Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BT-11-EoE

Identifier Type: -

Identifier Source: org_study_id

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