NCT03709628

Brief Summary

Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Geographic Reach
4 countries

5 active sites

Status
completed

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

Study Start

First participant enrolled

March 7, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

April 11, 2018

Last Update Submit

February 1, 2021

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (4)

  • Cmax

    Maximum observed plasma concentration

    Day1, Day13

  • Tmax

    Time to maximum observed plasma concentration

    Day1

  • AUC0-24

    Area under the plasma concentration time curve from time 0 to 24 hours

    Day1; Day13

  • T1/2

    Terminal elimination half-life

    Day1; Day13

Secondary Outcomes (9)

  • AE

    Up to Day22

  • RR

    Up to Day22

  • QRS complex

    Up to Day22

  • QT

    Up to Day22

  • PR

    Up to Day22

  • +4 more secondary outcomes

Other Outcomes (4)

  • Gut Microbiome

    Up to Day22

  • Inflammatory Biomarkers

    Up to Day22

  • Inflammatory Biomarkers

    Up to Day22

  • +1 more other outcomes

Study Arms (1)

Patients with active Crohn's disease

EXPERIMENTAL

EB8018: 3000 mg for the single dose in Part 1 (2 sentinel patients) and 1500 mg BID for multiple dose administration over 13 days in Parts 1 and 2 (2 sentinel patients and 6 remaining patients), oral.

Drug: EB8018 (First-in-class FimH blocker)

Interventions

EB8018 (First-in-class FimH blocker)DRUG

Drug: EB8018 EB8018 is an orally administered, first-in-class, FimH blocker • In Part 1, a single oral dose of EB8018 3000 mg will be administered to the 2 sentinel patients in the morning on Day 1. In the multi-dose treatment period (part 1 and 2), multiple oral doses of EB8018 1500 mg will be administered to 2 + 6 patients BID (in the morning and evening) on Days 1 through 13.

Also known as: EB8018
Patients with active Crohn's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Selection Criteria: * Male and female patients of nonchildbearing potential ≥18 years of age at screening and Day -1 * Active Crohn's disease based on an elevated calprotectin at baseline.

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

Sponsors & Collaborators

Study Sites (5)

Medical University Vienna

Vienna, Austria

Location

Hôpital Claude Huriez

Lille, France

Location

Hôpital de l'Archet 2

Nice, France

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multicenter, open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

October 17, 2018

Study Start

March 7, 2018

Primary Completion

November 12, 2019

Study Completion

December 4, 2019

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

IT(1)FR(2)AU(1)DE(1)