E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to Moderate Plaque Psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with white scales. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the safety and efficacy of 3 different doses of EDP1815 for the treatment of psoriasis following daily dosing for 16 weeks. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy dose response of EDP1815 at Week 16 • To evaluate the maximal clinical benefit of EDP1815 at Week 16 • To evaluate the optimal dose of EDP1815 based on efficacy and safety up to Week 16 • To evaluate the safety and tolerability of EDP1815 (all dose levels) throughout the study • To evaluate relapse and rebound of plaque psoriasis after cessation of EDP1815
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Give written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 2. Males or females ≥18 and ≤70 years old at the time of informed consent. 3. A documented diagnosis of plaque psoriasis for ≥6 months. 4. 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: - a. PASI score of ≥6 and ≤15 and - b. PGA score of 2 or 3. All parameters in this criterion should be reconfirmed at baseline visit prior to randomization. 5. Meet the following contraception criteria: - a. Male participants: - i. A male participant must agree to use contraception as detailed in Appendix 13.1 of the study protocol during their participation in this study and for a period of 90 days after the last dose and refrain from donating sperm during this period. - b. Female participants: i. A female participant is eligible to participate if she is not pregnant (Appendix 13.1of the study protocol), not breastfeeding, and at least 1 of the following conditions applies: 1. Not a WOCBP as defined in Appendix 13.1, OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 13.1 during their participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (≥ 28 days) after the last dose. 6. Agrees to not increase their usual sun exposure during the study. |
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E.4 | Principal exclusion criteria |
1. Have received EDP1815 within the 3 months prior to screening. 2. Have a diagnosis of non-plaque psoriasis. 3. Plaque psoriasis restricted to scalp, palms, and soles only. 4. Evidence of skin conditions that would interfere with psoriasis evaluation or treatment response. 5. Have received systemic immunosuppressive therapy within 4 weeks of first administration of study drug. 6. Unresponsive to prior use of biologics 7. If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug. 8. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation within 4 weeks of first administration of study drug. This includes therapeutic doses of nonsteroidal 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. 9. 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. 10. Have used topical medications/treatments that could affect psoriasis or PGA evaluation within 2 weeks of the first administration of study drug. Topical unmedicated emollients and low-potency topical corticosteroids are not excluded. 11. Gastrointestinal tract disease that could interfere with GI delivery and transit time. 12. Active inflammatory bowel disease. 13. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2). 14. Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study. 15. Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment). 16. For women, serum creatinine ≥125 μmol/L (1.414 mg/dL); for men, serum creatinine ≥135 μmol/L (1.527 mg/dL). 17. ALT and AST >2 × ULN. 18. Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B. 19. History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening. 20. In the opinion of the investigator, evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG. 21. Current acute or chronic inflammatory disease other than psoriasis or psoriatic arthritis. 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. 22. Hypersensitivity to P histicola or to any of the excipients. 23. 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. 24. Any major or minor GI surgery within 6 months of screening. 25. Any major surgery within 6 months of screening. 26. 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. 27. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer. 28. Initiating any OTC or prescription medication including vitamins, herbal supplements and nutraceuticals , 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, however, supplements containing high doses of probiotics and prebiotics are not allowed at any point during the study. 29. Blood donation of >100 mL within 30 days of screening or >499 mL within 12 weeks of screening. 30. Unwillingness to comply with study procedures or unwillingness to cooperate fully with the investigator. 31. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The effect of EDP1815 on the percent change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 16 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Mean percentage change from baseline in PASI Score at Weeks 4, 8, and 12 • Mean absolute change from baseline in PASI Score at Weeks 4, 8, 12, and 16 • Achievement of PASI-50 at Weeks 4, 8, 12, and 16 • Time to first achievement of PASI-50 • Achievement of PASI-75, PASI-90 and PASI-100 at Week 16 • Achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16 • Achievement of PGA of 0 at Week 16 •Mean percentage change from baseline in PGA×BSA at Weeks 4, 8, 12, and 16 • Mean absolute change from baseline in PGA×BSA at Weeks 4, 8, 12, and 16 •Mean percentage change from baseline in LSS at Weeks 4, 8, 12, and 16 • Mean absolute change from baseline in LSS at Weeks 4, 8, 12, and 16 • Mean percentage change from baseline in DLQI score at Weeks 4, 8, 12, and 16 • Mean absolute change from baseline in DLQI score at Weeks 4, 8, 12, and 16 • Mean percentage change from baseline in mNAPSI total score at Weeks 4, 8, 12, and 16 • Mean absolute change from baseline in mNAPSI total score at Weeks 4, 8, 12, and 16 •Cumulative incidence of partial relapse at Weeks 20, 24, 28, and 40 •Cumulative incidence of complete relapse at Weeks 20, 24, 28 and 40 •Cumulative incidence of rebound at Weeks 20, 24, 28 and 40 • Safety (AE and SAE) through to the final follow-up visit for 28 days after cessation of dosing
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy endpoints - Weeks 4, 8, 12 and 16, & Weeks 20, 24, 28, 40. Safety (AE and SAE) -through to the final follow-up visit for 28 days after cessation of dosing |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Hungary |
Poland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |