PsoriasisPhase 2NCT04603027
A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
A Phase 2 study testing EDP1815 in people with Psoriasis and Plaque Psoriasis, run by Evelo Biosciences, Inc. at 29 sites in 4 countries.
Trial summary
This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis
- 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
- 249 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 21 Sep 2020to 6 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 and ≤70 years old at the time of informed consent.
- A documented diagnosis of plaque psoriasis for ≥6 months.
- Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of ≥3% and ≤10% and meet both of the following additional criteria:
- PASI score of ≥6 and ≤15, and
- PGA score of 2 or 3.
Who cannot join
- Have a diagnosis of non-plaque psoriasis.
- Plaque psoriasis restricted to scalp, palms, and soles only.
- Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- Unresponsive to prior use of biologics (including, but not limited to, TNFα inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T cells).
- If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
- Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to oral or injectable corticosteroids, retinoids, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of first administration of study drug. This includes therapeutic doses of non-steroidal anti-inflammatory drugs such as ibuprofen, although intermittent as required use as an analgesic is permitted when required. Chronic use of low dose aspirin for cardiovascular protection is permitted.
Show all 23Show fewer
- Currently receiving lithium, antimalarials, leflunomide, or IM gold, or have received lithium, antimalarials, IM gold, or leflunomide within 4 weeks of first administration of study drug.
- Have used topical medications/treatments that could affect psoriasis or PGA evaluation (including [but not limited to] high- and mid-potency corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, picrolimus, and tacrolimus) within 2 weeks of the first administration of study drug. Topical unmedicated emollients and low-potency topical corticosteroids are not excluded.
- Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.
- Active inflammatory bowel disease.
- Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).
- Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study.
- Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment).
- Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.
- History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening (includes stroke, transient ischemic attack, and coronary heart disease [angina pectoris, myocardial infarction, heart failure, revascularization procedures]).
- Current acute or chronic inflammatory disease other than psoriasis or psoriatic arthritis (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus). If a subject is off all treatment and is disease and has been symptom free for greater than 12 months, then the inflammatory disease is considered to be in remission and they may be enrolled.
- Hypersensitivity to P histicola or to any of the excipients.
- Active untreated mental or psychiatric disorder. Participants who are on stable dosing of medication for a mental or psychiatric disorder for at least 6 months before screening and whose treating physicians consider them to be mentally stable may be enrolled.
- Any major or minor GI surgery within 6 months of screening.
- Any major surgery within 6 months of screening.
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.
- Initiating any OTC or prescription medication including vitamins, herbal supplements and nutraceuticals (eg, supplements including high doses of probiotics and prebiotics as usually found in capsules/tablets/powders), except acetaminophen/paracetamol and anti-histamines, within 14 days prior to baseline or anticipates change in dosage for the duration of the study period. Note that probiotic and prebiotic foods that contain low doses are allowed (eg, yoghurt, kefir, kombucha, however, supplements containing high doses of probiotics and prebiotics are not allowed at any point during the study.
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
United Kingdom11 sites
MAC Clinical Research
Blackpool, Lancashire, FY2 0JH
MAC Clinical Research
Cannock, Staffordshire, WS11 0BN
Synexus - Wales Clinical Research Centre
Cardiff, Wales, CF15 9SS
Synexus - Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA
Synexus - Scotland Clinical Research Centre
Glasgow, G20 0SP
MAC Clinical Research
Leeds, West Yorkshire, LS10 1DU
Synexus - Manchester Clinical Research Centre
Manchester, M15 6SE
Synexus - Thames Valley Clinical Research Centre
Reading, Berkshire, RG2 0TG
MAC Clinical Research
Stockton-on-Tees, North Yorkshire, TS17 6EW
Synexus - Merseyside Clinical Research Centre
Waterloo, Liverpool, L22 0LG
Medicine Evaluation Unit
Wythenshawe, Manchester, M23 9QZ
United States8 sites
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, 29621
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, 45236
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, 32806
Oregon Medical Research Center PC
Portland, Oregon, 97223
Synexus Clinical Research US, Inc. - Santa Rosa
Santa Rosa, California, 95405
Synexus Clinical Research US, Inc. - St. Petersburg
St. Petersburg, Florida, 33781
ForCare Clinical Research
Tampa, Florida, 33624
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, 32162
Poland8 sites
Synexus - Czestochowa
Częstochowa, 42-202
Synexus - Gdansk
Gdansk, Pomeranian Voivodeship, 80-382
Synexus - Gdynia
Gdynia, Pomeranian Voivodeship, 81-537
Synexus - Katowice
Katowice, 40-040
Synexus - Lodz
Lodz
Synexus - Poznan
Poznan, Greater Poland Voivodeship, 60-702
Synexus - Warszawa
Warsaw, 01-192
Synexus - Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-088
Hungary2 sites
Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
Budapest, 1036
Synexus Zalaegerszeg Magyarország Egészségügyi Kft
Zalaegerszeg, 8900
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis. This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
- Conditions
- Psoriasis, Plaque Psoriasis
- Being tested
- EDP1815, Placebo
- Keywords
- PSO, mild psoriasis, moderate psoriasis, plaque psoriasis, psoriasis, EDP1815
- Medical subject headings
- Psoriasis
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, pharmaceutical preparation of a single strain of bacteria
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10^11 cells, capsule, once daily, 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
| Cohort 2 | Experimental | 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10^11 cells, capsule, once daily, 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
| Cohort 3 | Experimental | 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10^11 cells, capsule, once daily, 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage Change in PASI
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.
Measured: 16 weeks
Secondary outcomes (20)
Mean Percentage Change in PASI
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PASI from baseline at weeks 4, 8, and 12.
Measured: 12 weeks
Mean Absolute Change in PASI
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PASI from baseline at weeks 4, 8, 12, and 16.
Measured: 16 weeks
Achievement of PASI-50
The efficacy of EDP1815 will be measured using the achievement of PASI-50 at weeks 4, 8, 12, and 16. PASI-50 is defined by at least a 50% reduction from baseline in the PASI score.
Measured: 16 weeks
Time to First Achievement of PASI-50
The efficacy of EDP1815 will be measured using the time to first achievement of PASI-50
Measured: 20 weeks
Achievement of PASI-75
The efficacy of EDP1815 will be measured using the achievement of PASI-75 at week 16. PASI-75 response is defined by at least a 75% reduction from baseline in the PASI score.
Measured: 16 weeks
Achievement of PASI-90
The efficacy of EDP1815 will be measured using the achievement of PASI-90 at week 16.PASI-90 response is defined by at least a 90% reduction from baseline in the PASI score.
Measured: 16 weeks
Achievement of PASI-100
The efficacy of EDP1815 will be measured using the achievement of PASI-100 at week 16. PASI-100 response is defined as achieving a complete resolution of all disease.
Measured: 16 weeks
Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline
The efficacy of EDP1815 will be measured using the achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16 [PGA = Physician's Global Assessment]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of psoriasis.
Measured: 16 weeks
Achievement of PGA of 0
The efficacy of EDP1815 will be measured using the achievement of PGA of 0 at Week 16 [PGA = Physician's Global Assessment]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of psoriasis. A PGA 0 is defined as clear or no signs of psoriasis.
Measured: 16 weeks
Mean Percentage Change in PGAxBSA
[PGA = Physician's Global Assessment, BSA = Body Surface Area]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores.
Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent of the BSA is considered mild to moderate psoriasis. Psoriasis affecting more than 5 percent of the BSA is considered moderate to severe psoriasis.
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16.
Measured: 16 weeks
Mean Absolute Change in PGAxBSA
[PGA = Physician's Global Assessment, BSA = Body Surface Area]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores.
Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent of the BSA is considered mild to moderate psoriasis. Psoriasis affecting more than 5 percent of the BSA is considered moderate to severe psoriasis.
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16.
Measured: 16 weeks
Mean Percentage Change in LSS
The LSS is used to score the severity of psoriasis plaques. The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 (clear) to 4 (very severe), and the total LSS is the numerical sum of the 3-dimensional scores. The efficacy of EDP1815 will be measured using the mean percentage change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.
Measured: 16 weeks
Mean Absolute Change in LSS
The LSS is used to score the severity of psoriasis plaques. The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 (clear) to 4 (very severe), and the total LSS is the numerical sum of the 3-dimensional scores.The efficacy of EDP1815 will be measured using the mean absolute change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.
Measured: 16 weeks
Mean Percentage Change in DLQI
The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients' quality of life. The higher the score the more the impact on quality of life. The efficacy of EDP1815 will be measured using mean percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16.
Measured: 16 weeks
Mean Absolute Change in DLQI
The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients' quality of life. There are 10 questions each scored 0-3, the higher the score the more the impact on quality of life (Total score range 0-30; 0 = no impact, 30 = greatest impact).The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16
Measured: 16 weeks
Mean Percentage Change in mNAPSI
The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. The higher the score the more severe the nail bed psoriasis. The efficacy of EDP1815 will be measured using the mean percentage change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16
Measured: 16 weeks
Mean Absolute Change in mNAPSI
The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).The higher the score the more severe the nail bed psoriasis. The efficacy of EDP1815 will be measured using the mean absolute change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16
Measured: 16 weeks
Cumulative Incidence of Partial Relapse
The efficacy of EDP1815 will be measured by calculating the cumulative incidence of partial relapse at Weeks 20, 24, 28, and 40 for participants who were classified as responders at week 16. Partial relapse is defined as a loss of the PASI-50 response after week 16 and after cessation of study treatment, or commencing a new treatment for psoriasis.
Measured: 40 weeks
Cumulative Incidence of Complete Relapse
The efficacy of EDP1815 will be measured by calculating the cumulative incidence of complete relapse at Weeks 20, 24, 28, and 40 in participants who were considered as responders at week 16. Relapse is defined as an increase in the severity of the psoriasis as measured by PASI to the baseline value or greater, or commencement of a new treatment for psoriasis.
Measured: 40 weeks
Cumulative Incidence of Rebound
The efficacy of EDP1815 will be measured by calculating the cumulative incidence of rebound at Weeks 20, 24, 28, and 40 in participants with at least one PASI assessment after the end of treatment. Rebound is defined as an increase in the severity of the psoriasis as measured by PASI to 125% of baseline score or above, or onset of new pustular/erythrodermic psoriasis, within 3 months of cessation of study treatment.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start21 Sep 2020
- Primary completion2 Jul 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Ehst, MD PhD, Principal investigator, Oregon Medical Research CenterDouglas Maslin, MPhil MBBS, Study director, Evelo Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603027
- Sponsor's protocol ID
- EDP1815-201
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2020
- Last updated
- 19 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehst BD, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Front Med (Lausanne). 2024 May 15;11:1292406. doi: 10.3389/fmed.2024.1292406. eCollection 2024.
PubMed 38813388
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04603027
- Acronym / sponsor ID
- EDP1815-201
- Conditions
- Psoriasis, Plaque Psoriasis
- Keywords
- PSO, mild psoriasis, moderate psoriasis, plaque psoriasis, psoriasis, EDP1815
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Posted 19 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis. This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EDP1815, Drug: Placebo75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10^11 cells, capsule, once daily, 16 weeks |
| Cohort 2 | Experimental | Drug: EDP1815, Drug: Placebo75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10^11 cells, capsule, once daily, 16 weeks |
| Cohort 3 | Experimental | Drug: EDP1815, Drug: Placebo75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10^11 cells, capsule, once daily, 16 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 and ≤70 years old at the time of informed consent.
- A documented diagnosis of plaque psoriasis for ≥6 months.
- Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of ≥3% and ≤10% and meet both of the following additional criteria:
Key exclusion criteria (23 listed)
- Have a diagnosis of non-plaque psoriasis.
- Plaque psoriasis restricted to scalp, palms, and soles only.
- Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- Unresponsive to prior use of biologics (including, but not limited to, TNFα inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T cells).
- If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
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, pharmaceutical preparation of a single strain of bacteria | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo oral capsule | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Mean Percentage Change in PASI
Time frame: 16 weeks
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.
20 secondary outcomes
Mean Percentage Change in PASI
Time frame: 12 weeks
Mean Absolute Change in PASI
Time frame: 16 weeks
Achievement of PASI-50
Time frame: 16 weeks
Time to First Achievement of PASI-50
Time frame: 20 weeks
Achievement of PASI-75
Time frame: 16 weeks
Achievement of PASI-90
Time frame: 16 weeks
Achievement of PASI-100
Time frame: 16 weeks
Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline
Time frame: 16 weeks
Achievement of PGA of 0
Time frame: 16 weeks
Mean Percentage Change in PGAxBSA
Time frame: 16 weeks
Mean Absolute Change in PGAxBSA
Time frame: 16 weeks
Mean Percentage Change in LSS
Time frame: 16 weeks
Mean Absolute Change in LSS
Time frame: 16 weeks
Mean Percentage Change in DLQI
Time frame: 16 weeks
Mean Absolute Change in DLQI
Time frame: 16 weeks
Mean Percentage Change in mNAPSI
Time frame: 16 weeks
Mean Absolute Change in mNAPSI
Time frame: 16 weeks
Cumulative Incidence of Partial Relapse
Time frame: 40 weeks
Cumulative Incidence of Complete Relapse
Time frame: 40 weeks
Cumulative Incidence of Rebound
Time frame: 40 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38813388Ehst BD, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Front Med (Lausanne). 2024 May 15;11:1292406. doi: 10.3389/fmed.2024.1292406. eCollection 2024.
- 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.
Benjamin Ehst, MD PhD principal investigator
Oregon Medical Research Center
Douglas Maslin, MPhil MBBS study director
Evelo Biosciences
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP1815 in people with Psoriasis and Plaque Psoriasis, run by Evelo Biosciences, Inc. at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, United States, Poland, Hungary. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percentage Change in PASI (time frame: 16 weeks). 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 NCT04603027, 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 Dec 2022.