PsoriasisPhase 1NCT03542994
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
A Phase 1 study testing EDP1066 in people with Psoriasis and Atopic Dermatitis, run by Evelo Biosciences, Inc. at 7 sites in United Kingdom.
Trial summary
Evelo will investigate the safety and tolerability of EDP1066 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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- EDP1066
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 24 Apr 2019to 3 Jan 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- 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 ≤ 5% 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 2 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 b. 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
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
MAC Clinical Research
Barnsley, S75 3DL
MAC Clinical Research
Cannock, WS11 0BN
University of Surrey Clinical Research Center
Guildford, Surrey, GU2 7XP
Royal Liverpool Clinical Research Unit
Liverpool, L78XP
MAC Clinical Research
Manchester, M13 9NQ
Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
Manchester, M23 9QZ
MAC Clinical Research
Stockton-on-Tees, TS17 6EW
About this study
Official title: A Phase 1a/1b Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Evelo will investigate the safety and tolerability of EDP1066 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 EDP1066. 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 EDP1066 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
- EDP1066, Placebo oral capsule
- 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.
EDP1066Other
EDP1066 is an orally administered monoclonal microbial
Placebo oral capsuleDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | 12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 2 | Other | 12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 3 | Other | 12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 4 | Other | 12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 5 | Other | 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 6 | Other | up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 660 mg, capsule, once daily, 29 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 7 | Other | up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 8 | Other | up to 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3g, capsule, once daily, 29 days Receives: Other: EDP1066; Drug: Placebo oral capsule |
| Cohort 9 | Other | up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days Receives: Other: EDP1066; 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 60
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 60
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Measured: Day 0 to Day 60
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 1 to Day 60
GI safety measurement through biomarker analysis
GI safety measurement through fecal calprotectin analysis
Measured: Day 1 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 EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Measured: Day 0 to Day 60
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 EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Measured: Day 0 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start24 Apr 2019
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 9 cohorts and will test doses of EDP1066 versus placebo. The safety and tolerability of EDP1066 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
- 114 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 BiosciencesDaryl Bendel, MBChB, MBA, Principal investigator, University of SurreyGiuseppe Fiore, MD, Principal investigator, Medicines Evaluation Unit LtdAliya Asher, MD, Principal investigator, MAC Clinical ResearchRichard Fitzgerald, MD, Principal investigator, Royal Liverpool Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542994
- Sponsor's protocol ID
- EDP1066-001
- Other IDs
- 2017-004337-90, 2017
- Status last verified
- Nov 2021
- First submitted
- 24 Apr 2018
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03542994
- Acronym / sponsor ID
- EDP1066-001
- Conditions
- Psoriasis, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 1 Jun 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 EDP1066 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 EDP1066. 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 EDP1066 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
- 9
- 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 9 cohorts and will test doses of EDP1066 versus placebo. The safety and tolerability of EDP1066 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 | Other: EDP1066, Drug: Placebo oral capsule12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days |
| Cohort 2 | Other | Other: EDP1066, Drug: Placebo oral capsule12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days |
| Cohort 3 | Other | Other: EDP1066, Drug: Placebo oral capsule12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days |
| Cohort 4 | Other | Other: EDP1066, Drug: Placebo oral capsule12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days |
| Cohort 5 | Other | Other: EDP1066, Drug: Placebo oral capsule24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days |
| Cohort 6 | Other | Other: EDP1066, Drug: Placebo oral capsuleup to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days |
| Cohort 7 | Other | Other: EDP1066, Drug: Placebo oral capsuleup to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days |
| Cohort 8 | Other | Other: EDP1066, Drug: Placebo oral capsuleup to 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3g, capsule, once daily, 29 days |
| Cohort 9 | Other | Other: EDP1066, Drug: Placebo oral capsuleup to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 ≤ 5% 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 (7 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 2 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 |
|---|---|---|
| EDP1066EDP1066 is an orally administered monoclonal microbial | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| Placebo oral capsuleplacebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Safety and tolerability measured through Adverse Events (AEs)
Time frame: Day 1 to Day 60
Number of participants with AEs by seriousness and relationship to treatment
Safety and tolerability measured through lab measurements
Time frame: Day 0 to Day 60
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 60
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Safety and tolerability measured through physical examination
Time frame: Day 1 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 1 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 60
Clinical improvement in subjects with mild to moderate atopic dermatitis
Time frame: Day 0 to Day 60
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 9 Nov 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.
Duncan McHale, MD, PhD study director
Evelo Biosciences
Daryl Bendel, MBChB, MBA principal investigator
University of Surrey
Giuseppe Fiore, MD principal investigator
Medicines Evaluation Unit Ltd
7 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 EDP1066 in people with Psoriasis and Atopic Dermatitis, run by Evelo Biosciences, Inc. at 7 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 7 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 60). 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?
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 9 Nov 2021.