Atopic DermatitisPhase 1NCT04927195
Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
A Phase 1 study testing EDP1867 in people with Atopic Dermatitis and Psoriasis, run by Evelo Biosciences, Inc. at 7 sites in United Kingdom.
Trial summary
This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Asthma
- What is being tested?
- EDP1867
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 23 Feb 2021to 28 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years to 65 years.
- Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline.
- Additional Inclusion Criteria for Participants with Moderate Atopic Dermatitis
- Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3.
- Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months.
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- All participants must be using an emollient and should continue to use this once daily (or more, as needed) for at least 14 days prior to randomisation, and must continue this treatment once daily (or more, as needed) throughout the study.
- Additional Inclusion Criteria for Participants with Moderate Psoriasis
- Participant has moderate plaque psoriasis with plaque covering BSA of ≥3% and ≤10% and meets both of the following additional criteria:
- PASI score of ≥6 and ≤15, and
- PGA score of 2 or 3.
- Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months.
- Additional Inclusion Criteria for Participants with Mild Asthma
- Participant has a diagnosis of stable asthma for at least six months
- FeNO of ≥40ppb.
- FEV1 ≥70% of predicted normal.
Who cannot join
- 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 (non-live vaccines are permitted).
- Participant requires treatment with an anti-inflammatory drug during the study period.
- Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
- Participant has renal or liver impairment
- Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening
- Participant has undergone major surgery within 4 weeks prior to Screening.
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- Any known cardiac abnormality
- Participant has a known history of human immunodeficiency virus (HIV)
- Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection
- Participant with any type of GI tract disease
- Participants with a history of any serious psychiatric condition; or on therapy for any psychiatric condition
- The participant has taken any over-the-counter (OTC) or prescription medication, within 14 days prior to baseline (Day -1); or anticipates an inability to abstain from these products for the duration of the study period
- The participant has a significant history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to Screening or has tested positive for drugs of abuse or alcohol at Screening or at baseline.
- The participant has had an acute, clinically significant illness within 30 days prior to the first dose of study intervention.
- Additional Exclusion Criteria for Participants with Atopic Dermatitis
- Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or has received such therapy within 4 weeks prior to Screening.
- Participant has received treatment with biologic agents within 12 months prior to first dose.
- Participant continues to use topical medications, other than emollients, that could affect atopic dermatitis 2 weeks prior to the start of dosing.
- Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle
- Additional Exclusion Criteria for Participants with Psoriasis
- Psoriasis restricted to scalp, palm, and/or soles only.
- Non-plaque type of psoriasis
- Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy or has received such therapy within 4 weeks prior to Screening
- Participant has received treatment with biologic agents within 12 months prior to first dose.
- Participant continues to use topical medications that could affect psoriasis within 2 weeks prior to the start of dosing
- Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle
- Additional Exclusion Criteria for Participants with Asthma
- History of life-threatening asthma, or a visit to the emergency department for asthma in the 6 months prior to screening, or exacerbation requiring oral corticosteroids within the previous 3 months.
- Smoker or nicotine user within the 3 months prior to screening; or a previous smoker with a greater than 10 pack year history.
- Other significant non-reversible pulmonary disease
- Use of the following medicines within the specified time-frame prior to screening:
- Long-acting inhaled β2-agonists: 8 weeks. Note: short-acting inhaled β2-agonists are permitted as required.
- Anti-IgE therapy: 6 months
- Inhaled corticosteroids: 8 weeks
- Oral or Injected corticosteroids: 8 weeks
- Intranasal or topical steroids: 4 weeks
- Leukotriene antagonists: 2 weeks
- Long-acting muscarinic antagonist: 8 weeks
- Xanthines (excluding caffeine), anticholinergics, cromoglycates: 1 week.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
MAC Clinical Research
Blackpool, Lancashire, FY2 0JH
MAC Clinical Research
Cannock, South Staffordshire, WS11 0BN
MAC Clinical Research
Leeds, West Yorkshire, LS10 1DU
MAC Clinical Research
Liverpool, Merseyside, L34 1BH
MAC Clinical Research Manchester
Manchester, Greater Manchester, M13 9NQ
Medicines Evaluation Unit (MEU)
Manchester, Greater Manchester, M23 9QZ
MAC Clinical Research
Stockton-on-Tees, Teeside, TS17 6EW
About this study
Official title: A Ph1a/1b, First in Human, Participant and Investigator-blind Sponsor-unblinded Randomized Placebo-controlled Multiple Dose Study of EDP1867 in Healthy Volunteers & Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
Read the detailed description
This is a phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild asthma. This study has been designed to investigate the clinical safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
- Conditions
- Atopic Dermatitis, Psoriasis, Asthma
- Being tested
- EDP1867, Placebo
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1867Drug
EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10^11 cells, capsules, once daily, 14 days total Receives: Drug: EDP1867; Drug: Placebo |
| Cohort 2 | Experimental | 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10^12 cells, capsules, once daily, 14 days total Receives: Drug: EDP1867; Drug: Placebo |
| Cohort 3 | Experimental | 24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days Receives: Drug: EDP1867; Drug: Placebo |
| Cohort 4 | Experimental | 24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days Receives: Drug: EDP1867; Drug: Placebo |
| Cohort 5 | Experimental | 24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days Receives: Drug: EDP1867; Drug: Placebo |
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 1 to Day 70
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Measured: Day 1 to Day 70
Safety and tolerability measured through physical examination
Physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, oral cavity, GI and neurological systems. Height and weight will also be measured and recorded. Number of participants with clinically relevant changes from baseline (Day 0) physical examination parameters
Measured: Day 1 to Day 70
Safety and tolerability measured through vital signs
Blood pressure, pulse rate, respiratory rate, oxygen saturations and temperature will be assessed. Number of participants with clinically relevant changes in vital signs from baseline (Day 0)
Measured: Day 1 to Day 70
Secondary outcomes (40)
Change in EASI score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in EASI (Eczema Area and Severity Index) score
Measured: Day 1 to Day 70
Percentage change in EASI score
The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in EASI (Eczema Area and Severity Index) score
Measured: Day 1 to Day 70
Change in SCORAD score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in SCORAD (SCORing Atopic Dermatitis) score
Measured: Day 1 to Day 70
Percentage change in SCORAD score
The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in SCORAD (SCORing Atopic Dermatitis) score
Measured: Day 1 to Day 70
Change in BSA
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in BSA (Body Surface Area)
Measured: Day 1 to Day 70
Percentage change in BSA
The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in BSA (Body Surface Area)
Measured: Day 1 to Day 70
Change in IGA x BSA
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in IGA x BSA [IGA = Investigator's Global Assessment, BSA = Body Surface Area]
Measured: Day 1 to Day 70
Percentage change in IGA x BSA
The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in IGA x BSA [IGA = Investigator's Global Assessment, BSA = Body Surface Area]
Measured: Day 1 to Day 70
Change in DLQI score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in DLQI (Dermatology Life Quality Index) score
Measured: Day 1 to Day 70
Change in POEM score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in POEM (Patient-Oriented Eczema Measure) score
Measured: Day 1 to Day 70
Change in Pruritis NRS average itch score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) average itch score
Measured: Day 1 to Day 70
Change in Pruritis NRS worst itch score
The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) worst itch score
Measured: Day 1 to Day 70
Achievement of EASI-50
The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-50 at day 70
Measured: Day 1 to Day 70
Achievement of EASI-75
The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-75 at day 70
Measured: Day 1 to Day 70
Achievement of IGA 0 or 1
The clinical improvement in subjects with atopic dermatitis will be measured using achievement of IGA 0 or 1 at day 70
Measured: Day 1 to Day 70
Change in PASI score
The clinical improvement in subjects with psoriasis will be measured using change from baseline in PASI score (Psoriasis Area and Severity Index Score)
Measured: Day 1 to Day 70
Percentage change in PASI score
The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PASI score (Psoriasis Area and Severity Index Score)
Measured: Day 1 to Day 70
Change in LSS
The clinical improvement in subjects with psoriasis will be measured using change from baseline in LSS (Lesion Severity Score)
Measured: Day 1 to Day 70
Change in BSA
The clinical improvement in subjects with psoriasis will be measured using change from baseline in BSA (Body Surface Area)
Measured: Day 1 to Day 70
Percentage change in BSA
The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in BSA (Body Surface Area)
Measured: Day 1 to Day 70
Change in PGA x BSA
The clinical improvement in subjects with psoriasis will be measured using change from baseline in PGA x BSA [PGA= Physician's Global Assessment; BSA = Body Surface Area)
Measured: Day 1 to Day 70
Percentage change in PGA x BSA
The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PGA x BSA [PGA= Physician's Global Assessment; BSA = Body Surface Area)
Measured: Day 1 to Day 70
Change in DLQI
The clinical improvement in subjects with psoriasis will be measured using change from baseline in DLQI (Dermatology Life Quality Index) score
Measured: Day 1 to Day 70
Achievement of PASI-50
The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-50 at Day 70
Measured: Day 1 to Day 70
Achievement of PASI-75
The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-75 at Day 70
Measured: Day 1 to Day 70
Achievement of PGA of 0 or 1
The clinical improvement in subjects with psoriasis will be measured using achievement of PGA of 0 or 1 at Day 70
Measured: Day 1 to Day 70
Change in FeNO
The clinical improvement in subjects with asthma will be measured using change from baseline in FeNO (Fractional exhaled Nitric Oxide)
Measured: Day 1 to Day 70
Percentage change in FeNO
The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FeNO
Measured: Day 1 to Day 70
Change in FEV1
The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1 (Forced Expiratory Volume)
Measured: Day 1 to Day 70
Percentage change in FEV1
The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1 (Forced Expiratory Volume)
Measured: Day 1 to Day 70
Change in FVC
The clinical improvement in subjects with asthma will be measured using change from baseline in FVC (Forced Vital Capacity)
Measured: Day 1 to Day 70
Percentage change in FVC
The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FVC (Forced Vital Capacity)
Measured: Day 1 to Day 70
Change in FEV1/FVC ratio
The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1/FVC ratio
Measured: Day 1 to Day 70
Percentage change in FEV1/FVC ratio
The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1/FVC ratio
Measured: Day 1 to Day 70
Change in PEF
The clinical improvement in subjects with asthma will be measured using change from baseline in PEF (Peak Expiratory Flow)
Measured: Day 1 to Day 70
Percentage change in PEF
The clinical improvement in subjects with asthma will be measured using percentage change from baseline in PEF (Peak Expiratory Flow)
Measured: Day 1 to Day 70
Change in number of exacerbations
The clinical improvement in subjects with asthma will be measured using change from baseline in number of exacerbations across the treatment period
Measured: Day 1 to Day 56
Occurrence of any exacerbation
The clinical improvement in subjects with asthma will be measured using the occurrence of any exacerbation during the treatment period
Measured: Day 1 to Day 56
Number of puffs of SABA medication
The clinical improvement in subjects with asthma will be measured using the number of puffs of SABA medication used in the 7 days prior to Day 28 and Day 56
Measured: Day 1 to Day 56
Use of any SABA medication
The clinical improvement in subjects with asthma will be measured using the occurrence of use of any SABA medication during the treatment period
Measured: Day 1 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start23 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pui Man Leung, MBChB MRCP FFPM DPM, Principal investigator, MAC Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927195
- Sponsor's protocol ID
- EDP1867-101
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ph1a/1b, First in Human, Participant and Investigator-blind Sponsor-unblinded Randomized Placebo-controlled Multiple Dose Study of EDP1867 in Healthy Volunteers & Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
- ClinicalTrials.gov ID
- NCT04927195
- Acronym / sponsor ID
- EDP1867-101
- Conditions
- Atopic Dermatitis, Psoriasis, Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Jun 2021 (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.
This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
Detailed description
This is a phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild asthma. This study has been designed to investigate the clinical safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EDP1867, Drug: Placebo12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10^11 cells, capsules, once daily, 14 days total |
| Cohort 2 | Experimental | Drug: EDP1867, Drug: Placebo12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10^12 cells, capsules, once daily, 14 days total |
| Cohort 3 | Experimental | Drug: EDP1867, Drug: Placebo24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days |
| Cohort 4 | Experimental | Drug: EDP1867, Drug: Placebo24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days |
| Cohort 5 | Experimental | Drug: EDP1867, Drug: Placebo24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, 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 (16 listed)
- Age ≥ 18 years to 65 years.
- Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline.
- Additional Inclusion Criteria for Participants with Moderate Atopic Dermatitis
- Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3.
Key exclusion criteria (39 listed)
- 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 (non-live vaccines are permitted).
- Participant requires treatment with an anti-inflammatory drug during the study period.
- Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
- Participant has renal or liver impairment
- Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening
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 |
|---|---|---|
| EDP1867EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo oral capsule | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
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 1 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 1 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 1 to Day 70
Physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, oral cavity, GI and neurological systems. Height and weight will also be measured and recorded. Number of participants with clinically relevant changes from baseline (Day 0) physical examination parameters
Safety and tolerability measured through vital signs
Time frame: Day 1 to Day 70
Blood pressure, pulse rate, respiratory rate, oxygen saturations and temperature will be assessed. Number of participants with clinically relevant changes in vital signs from baseline (Day 0)
40 secondary outcomes
Change in EASI score
Time frame: Day 1 to Day 70
Percentage change in EASI score
Time frame: Day 1 to Day 70
Change in SCORAD score
Time frame: Day 1 to Day 70
Percentage change in SCORAD score
Time frame: Day 1 to Day 70
Change in BSA
Time frame: Day 1 to Day 70
Percentage change in BSA
Time frame: Day 1 to Day 70
Change in IGA x BSA
Time frame: Day 1 to Day 70
Percentage change in IGA x BSA
Time frame: Day 1 to Day 70
Change in DLQI score
Time frame: Day 1 to Day 70
Change in POEM score
Time frame: Day 1 to Day 70
Change in Pruritis NRS average itch score
Time frame: Day 1 to Day 70
Change in Pruritis NRS worst itch score
Time frame: Day 1 to Day 70
Achievement of EASI-50
Time frame: Day 1 to Day 70
Achievement of EASI-75
Time frame: Day 1 to Day 70
Achievement of IGA 0 or 1
Time frame: Day 1 to Day 70
Change in PASI score
Time frame: Day 1 to Day 70
Percentage change in PASI score
Time frame: Day 1 to Day 70
Change in LSS
Time frame: Day 1 to Day 70
Change in BSA
Time frame: Day 1 to Day 70
Percentage change in BSA
Time frame: Day 1 to Day 70
Change in PGA x BSA
Time frame: Day 1 to Day 70
Percentage change in PGA x BSA
Time frame: Day 1 to Day 70
Change in DLQI
Time frame: Day 1 to Day 70
Achievement of PASI-50
Time frame: Day 1 to Day 70
Achievement of PASI-75
Time frame: Day 1 to Day 70
Achievement of PGA of 0 or 1
Time frame: Day 1 to Day 70
Change in FeNO
Time frame: Day 1 to Day 70
Percentage change in FeNO
Time frame: Day 1 to Day 70
Change in FEV1
Time frame: Day 1 to Day 70
Percentage change in FEV1
Time frame: Day 1 to Day 70
Change in FVC
Time frame: Day 1 to Day 70
Percentage change in FVC
Time frame: Day 1 to Day 70
Change in FEV1/FVC ratio
Time frame: Day 1 to Day 70
Percentage change in FEV1/FVC ratio
Time frame: Day 1 to Day 70
Change in PEF
Time frame: Day 1 to Day 70
Percentage change in PEF
Time frame: Day 1 to Day 70
Change in number of exacerbations
Time frame: Day 1 to Day 56
Occurrence of any exacerbation
Time frame: Day 1 to Day 56
Number of puffs of SABA medication
Time frame: Day 1 to Day 56
Use of any SABA medication
Time frame: Day 1 to Day 56
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 7 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Pui Man Leung, MBChB MRCP FFPM DPM principal investigator
MAC Clinical Research
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 EDP1867 in people with Atopic Dermatitis and Psoriasis, 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 16 inclusion and 39 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 7 Oct 2022. 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 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?
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 7 Oct 2022.