Crohn DiseasePhase 1EBFIM117NCT03709628
A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
A Phase 1 study testing EB8018 (First-in-class FimH blocker) in people with Crohn Disease, run by Enterome at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- EB8018 (First-in-class FimH blocker)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 7 Mar 2018to 4 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- EB8018 (First-in-class FimH blocker)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB8018 (First-in-class FimH blocker)Drug
Also called EB8018
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EB8018 (First-in-class FimH blocker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: Day1, Day13
Tmax
Time to maximum observed plasma concentration
Measured: Day1
AUC0-24
Area under the plasma concentration time curve from time 0 to 24 hours
Measured: Day1; Day13
T1/2
Terminal elimination half-life
Measured: Day1; Day13
Secondary outcomes (9)
AE
Adverse events
Measured: Up to Day22
RR
Inter-Beat intervalle (sec)
Measured: Up to Day22
QRS complex
intervalle (sec)
Measured: Up to Day22
QT
duration (sec)
Measured: Up to Day22
PR
intervalle (sec)
Measured: Up to Day22
HR
Heart rate (bpm)
Measured: Up to Day22
BP
Blood pressure (mmHg)
Measured: Up to Day22
RR
Respiratory rate (breaths per minute)
Measured: Up to Day22
Temp
Temperature (C°)
Measured: Up to Day22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start7 Mar 2018
- Primary completion12 Nov 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, open-label
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709628
- Sponsor's protocol ID
- Enterome
- Acronym
- EBFIM117
- Status last verified
- Feb 2021
- First submitted
- 11 Apr 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT03709628
- Acronym / sponsor ID
- EBFIM117 / Enterome
- Conditions
- Crohn Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EnteromeIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, open-label
| Arm | Type | Receives |
|---|---|---|
| Patients with active Crohn's disease | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB8018 (First-in-class FimH blocker)Also: EB8018Drug: 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. | Drug | Patients with active Crohn's disease |
Primary outcome
Cmax
Time frame: Day1, Day13
Maximum observed plasma concentration
Tmax
Time frame: Day1
Time to maximum observed plasma concentration
AUC0-24
Time frame: Day1; Day13
Area under the plasma concentration time curve from time 0 to 24 hours
T1/2
Time frame: Day1; Day13
Terminal elimination half-life
9 secondary outcomes
AE
Time frame: Up to Day22
RR
Time frame: Up to Day22
QRS complex
Time frame: Up to Day22
QT
Time frame: Up to Day22
PR
Time frame: Up to Day22
HR
Time frame: Up to Day22
BP
Time frame: Up to Day22
RR
Time frame: Up to Day22
Temp
Time frame: Up to Day22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EB8018 (First-in-class FimH blocker) in people with Crohn Disease, run by Enterome at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Austria, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day1, Day13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.