KLH and Imiquimod Induced Skin Inflammation in Healthy VolunteersPhase 1NCT05682222
Evaluation of the Immunopharmacology of EDP1815 and EDP2939
A Phase 1 study testing EDP1815 and EDP2939 in people with KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers, run by Evelo Biosciences, Inc. at 1 site in Netherlands.
Trial summary
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
- What is being tested?
- EDP1815 and EDP2939
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jun 2022to 14 Oct 2022
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving signed informed consent, and willing to comply with requirements of the study.
- Age 18 years to 45 years, inclusive.
- Body mass index of 18 to 35 kg/m2, inclusive.
- Caucasian.
- Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests.
Who cannot join
- Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
- Has previously received Immucothel® or KLH.
- Allergy to Alhydrogel® or Aldara® (imiquimod cream).
- Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas.
- Previous diagnosis of psoriasis.
- History of pathological scar formation (e.g. keloid scar).
Show all 12Show fewer
- History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma).
- Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
- Currently has an infection or has needed antibiotics within 6 weeks before the study.
- Current smoker of more than 5 cigarettes per day
- Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study
- History of Schistosomiasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
Read the detailed description
This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.
EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.
Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.
- Being tested
- EDP1815, EDP2939, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815Drug
EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.
EDP2939Drug
EDP2939 is a pharmaceutical preparation of extracellular vesicles.
Placebo oral capsuleDrug
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo. Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 2 | Other | EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 3 | Other | EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. Receives: Drug: EDP2939; Drug: Placebo oral capsule |
| Cohort 4 | Other | EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. Receives: Drug: EDP2939; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
KLH-induced immune reaction.
This will be measured as basal flow (arbitrary units, AU) by LSCI.
Measured: At 24 hours after Day 57 intradermal re-challenge.
Secondary outcomes (13)
KLH-induced immune reaction - basal flow.
This will be measured as basal flow (AU) by LSCI.
Measured: At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
KLH-induced immune reaction - flare.
This will be measured as flare (AU) by LSCI.
Measured: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
KLH-induced immune reaction - erythema.
This will be measured as erythema (AU) by multispectral imaging.
Measured: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
IMQ-induced immune reaction - basal flow.
This will be measured as basal flow (AU) by LSCI.
Measured: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
IMQ-induced immune reaction - flare.
This will be measured as flare (AU) by LSCI.
Measured: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
IMQ-induced immune reaction - erythema.
This will be measured as erythema (AU) by multispectral imaging.
Measured: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
Specific B-cell response to KLH.
This will be measured as anti-KLH IgM and IgG (% of baseline concentration).
Measured: After Day 57 intradermal re-challenge.
Serious adverse event (SAE) and adverse event (AE) incidents.
SAEs and AEs assessed by: type, frequency, severity and treatment-relatedness of the event.
Measured: Up to Day 74.
Number of participants with blood laboratory safety abnormalities.
Measured: Up to Day 74.
Number of participants with urinary laboratory safety abnormalities.
Measured: Up to Day 74.
Number of participants with electrocardiogram (ECG) abnormalities.
Measured: Up to Day 74.
Number of participants with vital signs abnormalities.
Measured: Up to Day 74.
Number of participants with physical examination abnormalities.
Measured: Up to Day 74.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start27 Jun 2022
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KLH and Imiquimod Induced Skin Inflammation in Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- This is a single-center, randomized, double-blind, placebo-controlled, platform trial to evaluate the effects of EDP1815 and EDP2939 on the systemic immune system, using intradermal KLH and topical IMQ skin challenges. A total of at least 72 healthy volunteers will be divided into 4 cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682222
- Sponsor's protocol ID
- EDP1815-105
- Status last verified
- May 2023
- First submitted
- 22 Jul 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eveleens Maarse BC, Ronner MN, Jansen MAA, Niemeyer-van der Kolk T, In 't Veld AE, Klaassen ES, Ahmad S, Itano A, McHale D, Moerland M. Immunomodulating effects of the single bacterial strain therapy EDP1815 on innate and adaptive immune challenge responses - a randomized, placebo-controlled clinical trial. Immunol Res. 2024 Aug;72(4):776-787. doi: 10.1007/s12026-024-09484-7. Epub 2024 May 15.
PubMed 38748319
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.
- ClinicalTrials.gov ID
- NCT05682222
- Acronym / sponsor ID
- EDP1815-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 12 Jan 2023 (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.
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
Detailed description
This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.
EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.
Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a single-center, randomized, double-blind, placebo-controlled, platform trial to evaluate the effects of EDP1815 and EDP2939 on the systemic immune system, using intradermal KLH and topical IMQ skin challenges. A total of at least 72 healthy volunteers will be divided into 4 cohorts.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: EDP1815, Drug: Placebo oral capsuleEDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo. |
| Cohort 2 | Other | Drug: EDP1815, Drug: Placebo oral capsuleEDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
| Cohort 3 | Other | Drug: EDP2939, Drug: Placebo oral capsuleEDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
| Cohort 4 | Other | Drug: EDP2939, Drug: Placebo oral capsuleEDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Capable of giving signed informed consent, and willing to comply with requirements of the study.
- Age 18 years to 45 years, inclusive.
- Body mass index of 18 to 35 kg/m2, inclusive.
- Caucasian.
- Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests.
Key exclusion criteria (12 listed)
- Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
- Has previously received Immucothel® or KLH.
- Allergy to Alhydrogel® or Aldara® (imiquimod cream).
- Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas.
- Previous diagnosis of psoriasis.
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 |
|---|---|---|
| EDP1815EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe. | Drug | Cohort 1, Cohort 2 |
| EDP2939EDP2939 is a pharmaceutical preparation of extracellular vesicles. | Drug | Cohort 3, Cohort 4 |
| Placebo oral capsulePlacebo. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
KLH-induced immune reaction.
Time frame: At 24 hours after Day 57 intradermal re-challenge.
This will be measured as basal flow (arbitrary units, AU) by LSCI.
13 secondary outcomes
KLH-induced immune reaction - basal flow.
Time frame: At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
KLH-induced immune reaction - flare.
Time frame: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
KLH-induced immune reaction - erythema.
Time frame: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
IMQ-induced immune reaction - basal flow.
Time frame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
IMQ-induced immune reaction - flare.
Time frame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
IMQ-induced immune reaction - erythema.
Time frame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
Specific B-cell response to KLH.
Time frame: After Day 57 intradermal re-challenge.
Serious adverse event (SAE) and adverse event (AE) incidents.
Time frame: Up to Day 74.
Number of participants with blood laboratory safety abnormalities.
Time frame: Up to Day 74.
Number of participants with urinary laboratory safety abnormalities.
Time frame: Up to Day 74.
Number of participants with electrocardiogram (ECG) abnormalities.
Time frame: Up to Day 74.
Number of participants with vital signs abnormalities.
Time frame: Up to Day 74.
Number of participants with physical examination abnormalities.
Time frame: Up to Day 74.
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 19 May 2023.
- Derived from this study: PubMed 38748319Eveleens Maarse BC, Ronner MN, Jansen MAA, Niemeyer-van der Kolk T, In 't Veld AE, Klaassen ES, Ahmad S, Itano A, McHale D, Moerland M. Immunomodulating effects of the single bacterial strain therapy EDP1815 on innate and adaptive immune challenge responses - a randomized, placebo-controlled clinical trial. Immunol Res. 2024 Aug;72(4):776-787. doi: 10.1007/s12026-024-09484-7. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP1815 and EDP2939 in people with KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers, run by Evelo Biosciences, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
KLH-induced immune reaction. (time frame: At 24 hours after Day 57 intradermal re-challenge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682222, which also lists 1 linked publication.
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 19 May 2023.