A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Phase 1

Completed

• Conditions: Crohn Disease
• Interventions: Drug: EB8018 (First-in-class FimH blocker)

• Registration Number: NCT03709628
• Lead Sponsor: Enterome

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.

Detailed Description

This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease.

Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.

Study Timeline

• Study Start: 2018-03-07
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-17
• Primary Completion: 2019-11-12
• Study Completion: 2019-12-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with active Crohn's disease	EB8018 (First-in-class FimH blocker)	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.

Primary Outcome Measures

Name	Time	Method
Cmax	Day1, Day13	Maximum observed plasma concentration
Tmax	Day1	Time to maximum observed plasma concentration
AUC0-24	Day1; Day13	Area under the plasma concentration time curve from time 0 to 24 hours
T1/2	Day1; Day13	Terminal elimination half-life

Secondary Outcome Measures

Name	Time	Method
QRS complex	Up to Day22	intervalle (sec)
QT	Up to Day22	duration (sec)
RR	Up to Day22	Respiratory rate (breaths per minute)
PR	Up to Day22	intervalle (sec)
HR	Up to Day22	Heart rate (bpm)
AE	Up to Day22	Adverse events
BP	Up to Day22	Blood pressure (mmHg)
Temp	Up to Day22	Temperature (C°)

Trial Locations

Locations (5)

Medical University Vienna; 🇦🇹 Wien, Austria

Hôpital Claude Huriez; 🇫🇷 Lille, France

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Hôpital de l'Archet 2; 🇫🇷 Nice, France

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy