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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03709628

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Enterome

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Austria, France, Germany, Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn Disease
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Istituto Clinico Humanitas, Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, ,

Site Contact

Silvio Danese, Prof

jmpaillarse@enterome.com

+33 1 85 76 10 62

Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, ,

Site Contact

Stefan Schreiber, Prof

jmpaillarse@enterome.com

+33 1 85 76 10 62

Hôpital de l'Archet 2, Nice, France

Status

Recruiting

Address

Hôpital de l'Archet 2

Nice, ,

Site Contact

Xavier HEBUTERNE, Prof

jmpaillarse@enterome.com

+33 1 85 76 10 62

Hôpital Claude Huriez, Lille, France

Status

Recruiting

Address

Hôpital Claude Huriez

Lille, ,

Site Contact

Pierre DESREUMAUX, Prof

jmpaillarse@enterome.com

+33 1 85 76 10 62

Medical University Vienna, Wien, Austria

Status

Recruiting

Address

Medical University Vienna

Wien, ,

Site Contact

Walter Reinisch, Prof

jmpaillarse@enterome.com

+33 1 85 76 10 62

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