Mild to Moderate Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: EDP1815
Product Code: EDP1815
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prevotella histicola
Current Sponsor code: EDP1815
Concentration unit: Other
Concentration type: equ
Sponsors
Evelo Biosciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 at least 1 of the following additional criteria: - a. PASI score of =6 and =15. - b. PGA score of 2 or 3. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 (eg, atopic dermatitis, fungal or bacterial superinfection). 5. 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. 6. Unresponsive to prior use of biologics (including, but not limited to, TNFa inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T cells). 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 (including [but not limited to] high- and mid-potency corticosteroids [Appendix 13.2], 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. 11. Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) 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 (includes stroke, transient ischemic attack, and coronary heart disease [angina pectoris, myocardial infarction, heart failure, revascularization procedures]). 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 conside
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of EDP1815 for the treatment of psoriasis following daily dosing for 16 weeks.;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 ;Secondary Objective: • 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;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Hungary, Poland, United Kingdom, United States
Contacts
Public ContactStuart Abel
Evelo Biosciences Inc.
Outcome results
None listed