Clinical trial NCT04603027: A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Plaque Psoriasis
Keywords: PSO
mild psoriasis
moderate psoriasis
plaque psoriasis
psoriasis
EDP1815
Lead sponsor: Evelo Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Key Inclusion Criteria:

1. Males or females ≥18 and ≤70 years old at the time of informed consent.
2. A documented diagnosis of plaque psoriasis for ≥6 months.
3. 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:

   1. PASI score of ≥6 and ≤15, and
   2. PGA score of 2 or 3.

Key Exclusion Criteria:

1. Have a diagnosis of non-plaque psoriasis.
2. Plaque psoriasis restricted to scalp, palms, and soles only.
3. 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.
4. 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).
5. If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
6. 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.
7. 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.
8. 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.
9. Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.
10. Active inflammatory bowel disease.
11. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).
12. Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study.
13. Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment).
14. Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.
15. History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening (includes stroke, transient ischemic attack, and coronary heart disease \[angina pectoris, myocardial infarction, heart failure, revascularization procedures\]).
16. 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.
17. Hypersensitivity to P histicola or to any of the excipients.
18. 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.
19. Any major or minor GI surgery within 6 months of screening.
20. Any major surgery within 6 months of screening.
21. 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.
22. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.
23. 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.

Primary outcomes:
measure: Mean Percentage Change in PASI
timeFrame: 16 weeks
Secondary outcomes:
measure: Mean Percentage Change in PASI
timeFrame: 12 weeks
measure: Mean Absolute Change in PASI
timeFrame: 16 weeks
measure: Achievement of PASI-50
timeFrame: 16 weeks
measure: Time to First Achievement of PASI-50
timeFrame: 20 weeks
measure: Achievement of PASI-75
timeFrame: 16 weeks
measure: Achievement of PASI-90
timeFrame: 16 weeks
measure: Achievement of PASI-100
timeFrame: 16 weeks
measure: Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline
timeFrame: 16 weeks
measure: Achievement of PGA of 0
timeFrame: 16 weeks
measure: Mean Percentage Change in PGAxBSA
timeFrame: 16 weeks
measure: Mean Absolute Change in PGAxBSA
timeFrame: 16 weeks
measure: Mean Percentage Change in LSS
timeFrame: 16 weeks
measure: Mean Absolute Change in LSS
timeFrame: 16 weeks
measure: Mean Percentage Change in DLQI
timeFrame: 16 weeks
measure: Mean Absolute Change in DLQI
timeFrame: 16 weeks
measure: Mean Percentage Change in mNAPSI
timeFrame: 16 weeks
measure: Mean Absolute Change in mNAPSI
timeFrame: 16 weeks
measure: Cumulative Incidence of Partial Relapse
timeFrame: 40 weeks
measure: Cumulative Incidence of Complete Relapse
timeFrame: 40 weeks
measure: Cumulative Incidence of Rebound
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Synexus Clinical Research US, Inc. - Santa Rosa
state: California
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc. - Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: Synexus Clinical Research US, Inc. - St. Petersburg
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc. - Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center PC
state: Oregon
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. - Anderson
state: South Carolina
city: Budapest
country: Hungary
facility: Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
city: Zalaegerszeg
country: Hungary
facility: Synexus Zalaegerszeg Magyarország Egészségügyi Kft
city: Wrocław
country: Poland
facility: Synexus - Wroclaw
state: Dolnoslaskie
city: Gdańsk
country: Poland
facility: Synexus - Gdansk
state: Pomorskie
city: Gdynia
country: Poland
facility: Synexus - Gdynia
state: Pomorskie
city: Poznań
country: Poland
facility: Synexus - Poznan
state: Wielkopolskie
city: Czestochowa
country: Poland
facility: Synexus - Czestochowa
city: Katowice
country: Poland
facility: Synexus - Katowice
city: Warszawa
country: Poland
facility: Synexus - Warszawa
city: Łódź
country: Poland
facility: Synexus - Lodz
city: Reading
country: United Kingdom
facility: Synexus - Thames Valley Clinical Research Centre
state: Berkshire
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research
state: Lancashire
city: Chorley
country: United Kingdom
facility: Synexus - Lancashire Clinical Research Centre
state: Lancashire
city: Waterloo
country: United Kingdom
facility: Synexus - Merseyside Clinical Research Centre
state: Liverpool
city: Wythenshawe
country: United Kingdom
facility: Medicine Evaluation Unit
state: Manchester
city: Stockton-on-Tees
country: United Kingdom
facility: MAC Clinical Research
state: North Yorkshire
city: Cannock
country: United Kingdom
facility: MAC Clinical Research
state: Staffordshire
city: Cardiff
country: United Kingdom
facility: Synexus - Wales Clinical Research Centre
state: Wales
city: Leeds
country: United Kingdom
facility: MAC Clinical Research
state: West Yorkshire
city: Glasgow
country: United Kingdom
facility: Synexus - Scotland Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Synexus - Manchester Clinical Research Centre
Study officials:
affiliation: Oregon Medical Research Center
name: Benjamin Ehst, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evelo Biosciences
name: Douglas Maslin, MPhil MBBS
role: STUDY_DIRECTOR
References: