NCT04835168

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

March 10, 2021

Last Update Submit

June 6, 2023

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of AEs

    12 Weeks

Study Arms (3)

BT-11 low

EXPERIMENTAL

Oral

Drug: BT-11 low

BT-11 high

EXPERIMENTAL

Oral

Drug: BT-11 high

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

BT-11 lowDRUG

Oral

BT-11 low
BT-11 highDRUG

Oral

BT-11 high
PlaceboDRUG

Oral

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
No patients enrolled

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

April 8, 2021

Study Start

January 30, 2022

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share