PsoriasisPhase 1NCT03733353
A Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
A Phase 1 study testing EDP1815 in people with Psoriasis and Atopic Dermatitis, run by Evelo Biosciences, Inc. at 9 sites in United Kingdom.
Trial summary
Evelo will investigate the safety and tolerability of EDP1815 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- EDP1815
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 19 Nov 2018to 29 Oct 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General:
- Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2 at Screening.
- Healthy Volunteers:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Mild to moderate psoriasis:
- Participant has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 10% of body surface area (BSA) (excluding the scalp).
Show all 11Show fewer
- Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
- Mild to moderate atopic dermatitis:
- Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement.
- Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months (IGA score of 2 or 3).
- Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.
Who cannot join
- Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with childbearing potential who is not using a medically accepted birth control method.
- Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
- Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration.
- Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic (maximum of 4 grams/day in any 24 hour period).
- Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to Investigational Medicinal Product (IMP) administration. When in doubt, the investigator should confer with the Sponsor study physician.
- Participant has renal or liver impairment, defined as:
- For healthy volunteers: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN), or iii. Alkaline phosphatase (ALP) and/or bilirubin > 1.5 x ULN
- For participants with mild to moderate atopic dermatitis or psoriasis: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. ALT or AST > 2 x ULN and/or bilirubin > 1.5 x ULN
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
UK-8
Barnsley
UK-7
Blackpool
UK-3
Cannock
UK-4
Leeds
UK-5
Liverpool
UK-1
London
UK-2
Manchester
UK-6
Manchester
UK-9
Stockton-on-Tees
About this study
Official title: A Phase 1 Randomized Double-Blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis or Atopic Dermatitis
Evelo will investigate the safety and tolerability of EDP1815 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1815. Since this clinical study is the first study in humans, the participants will be healthy volunteers or subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well. Investigation of EDP1815 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- EDP1815, Placebo oral capsule, Placebo oral tablet
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815Drug
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsuleDrug
Placebo
Placebo oral tabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | 12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=1/10th of HED, capsule, once daily, 15 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 2 | Other | 12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 15 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 3 | Other | 12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 29 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 4 | Other | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED capsule, once daily, 29 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 5 | Other | 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, mini-tablets in capsule, once daily, 29 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 6 | Other | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose=5 x HED, mini-tablets in capsule, once daily, 29 days. Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 7 | Other | 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 8 | Other | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days Receives: Drug: EDP1815; Drug: Placebo oral tablet |
| Cohort 9 | Other | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
| Cohort 10 | Other | 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days Receives: Drug: EDP1815; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measured through Adverse Events (AEs)
Number of participants with AEs by seriousness and relationship to treatment
Measured: Day 1 to Day 70
Safety and tolerability measured through lab measurements
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Measured: Day 0 to Day 70
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Measured: Day 0 to Day 70
Safety and tolerability measured through physical examination
Physical examination of stool samples based on the Bristol Stool Scale (Types 3 and 4 are ideal stool):
Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (easy to pass); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid
Measured: Day 0 to Day 60
GI safety measurement through biomarker analysis
GI safety measurement through fecal calprotectin analysis
Measured: Day 0 to Day 60
Secondary outcomes (2)
Clinical improvement in subjects with mild to moderate psoriasis
Change from baseline (Day 0) Psoriasis-area-and-severity index score (PASI) in response to EDP1815, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Measured: Day 0 to Day 70
Clinical improvement in subjects with mild to moderate atopic dermatitis
Change from baseline (Day 0) Eczema-area-and-severity index score (EASI) in response to EDP1815, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Measured: Day 0 to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start19 Nov 2018
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
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 PsoriasisStudies 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
- The study is a double-blind dose escalation cohort study in healthy volunteers and participants with either mild to moderate psoriasis or mild to moderate atopic dermatitis. The study consists of 10 cohorts and will test doses of EDP1815 versus placebo. The safety and tolerability of EDP1815 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duncan McHale, MD, PhD, Study director, Evelo Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733353
- Sponsor's protocol ID
- EDP1815-101
- Other IDs
- 2018-002807-32, 2018
- Status last verified
- Jan 2022
- First submitted
- 5 Nov 2018
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Itano A, Maslin D, Ramani K, Mehraei G, Carpenter N, Cormack T, Saghari M, Moerland M, Troy E, Caffry W, Wardwell-Scott L, Abel S, McHale D, Bodmer M. Clinical translation of anti-inflammatory effects of Prevotella histicola in Th1, Th2, and Th17 inflammation. Front Med (Lausanne). 2023 May 5;10:1070433. doi: 10.3389/fmed.2023.1070433. eCollection 2023.
PubMed 37215725
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Double-Blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis or Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03733353
- Acronym / sponsor ID
- EDP1815-101
- Conditions
- Psoriasis, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 7 Nov 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.
Evelo will investigate the safety and tolerability of EDP1815 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.
Detailed description
This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1815. Since this clinical study is the first study in humans, the participants will be healthy volunteers or subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well. Investigation of EDP1815 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- The study is a double-blind dose escalation cohort study in healthy volunteers and participants with either mild to moderate psoriasis or mild to moderate atopic dermatitis. The study consists of 10 cohorts and will test doses of EDP1815 versus placebo. The safety and tolerability of EDP1815 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: EDP1815, Drug: Placebo oral capsule12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=1/10th of HED, capsule, once daily, 15 days |
| Cohort 2 | Other | Drug: EDP1815, Drug: Placebo oral capsule12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 15 days |
| Cohort 3 | Other | Drug: EDP1815, Drug: Placebo oral capsule12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 29 days |
| Cohort 4 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED capsule, once daily, 29 days |
| Cohort 5 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, mini-tablets in capsule, once daily, 29 days |
| Cohort 6 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose=5 x HED, mini-tablets in capsule, once daily, 29 days. |
| Cohort 7 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days |
| Cohort 8 | Other | Drug: EDP1815, Drug: Placebo oral tablet24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days |
| Cohort 9 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days |
| Cohort 10 | Other | Drug: EDP1815, Drug: Placebo oral capsule24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2 at Screening.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participant has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 10% of body surface area (BSA) (excluding the scalp).
- Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
- Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement.
Key exclusion criteria (8 listed)
- Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with childbearing potential who is not using a medically accepted birth control method.
- Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
- Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration.
- Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic (maximum of 4 grams/day in any 24 hour period).
- Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to Investigational Medicinal Product (IMP) administration. When in doubt, the investigator should confer with the Sponsor study physician.
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 orally administered monoclonal microbial | Drug | Cohort 1, Cohort 10, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| Placebo oral capsulePlacebo | Drug | Cohort 1, Cohort 10, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 9 |
| Placebo oral tabletPlacebo | Drug | Cohort 8 |
Primary outcome
Safety and tolerability measured through Adverse Events (AEs)
Time frame: Day 1 to Day 70
Number of participants with AEs by seriousness and relationship to treatment
Safety and tolerability measured through lab measurements
Time frame: Day 0 to Day 70
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Safety and tolerability measured through ECG
Time frame: Day 0 to Day 70
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Safety and tolerability measured through physical examination
Time frame: Day 0 to Day 60
Physical examination of stool samples based on the Bristol Stool Scale (Types 3 and 4 are ideal stool): Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (easy to pass); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid
GI safety measurement through biomarker analysis
Time frame: Day 0 to Day 60
GI safety measurement through fecal calprotectin analysis
2 secondary outcomes
Clinical improvement in subjects with mild to moderate psoriasis
Time frame: Day 0 to Day 70
Clinical improvement in subjects with mild to moderate atopic dermatitis
Time frame: Day 0 to Day 70
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 10 Jan 2022.
- Derived from this study: PubMed 37215725Itano A, Maslin D, Ramani K, Mehraei G, Carpenter N, Cormack T, Saghari M, Moerland M, Troy E, Caffry W, Wardwell-Scott L, Abel S, McHale D, Bodmer M. Clinical translation of anti-inflammatory effects of Prevotella histicola in Th1, Th2, and Th17 inflammation. Front Med (Lausanne). 2023 May 5;10:1070433. doi: 10.3389/fmed.2023.1070433. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Duncan McHale, MD, PhD study director
Evelo Biosciences, Inc.
9 sites 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 in people with Psoriasis and Atopic Dermatitis, run by Evelo Biosciences, Inc. at 9 sites in United Kingdom.
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 11 inclusion and 8 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. 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?
Safety and tolerability measured through Adverse Events (AEs) (time frame: Day 1 to Day 70). The study lists 5 primary outcomes in all. 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 NCT03733353, 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 10 Jan 2022.