Moderate plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: EDP2939
Product Code: EDP2939
Pharmaceutical Form: Capsule
INN or Proposed INN: Not yet assigned
Current Sponsor code: EDP2939
Other descriptive name: EDP2939
Concentration unit: Other
C
Sponsors
Evelo Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent will be obtained prior to any screening procedures and in accordance with national, local, and institutional guidelines. 2. Contraception: A male participant with a female partner of child-bearing potential must meet the criteria for acceptable contraception as detailed in the protocol during the study and for a period of 90 days after the last dose. All male participants must refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: I. Not a woman of child-bearing potential, as defined in the protocol. OR II. A woman of child-bearing potential who agrees to follow the contraceptive guidance in the protocol during participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (=30 days) after the last dose 3. Males or females aged 18 to 75 years, inclusive, at the time of signing the ICF. 4. Body mass index of 18 to 35 kg/m2 inclusive. 5. A documented diagnosis of plaque psoriasis, with a patient- or clinician-reported disease duration of at least 6 months prior to screening. 6. Have plaque psoriasis meeting all of the following criteria at screening and baseline: a. PGA score of 3 (moderate), and b. BSA =5% and =20%, and c. PASI =5 and =20. 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 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: 1. Participant has GI tract disease that could interfere with the GI delivery and transit time of EDP2939. 2. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration. 3. Infection with HIV, HBV, or HCV; or known to be positive for HCV RNA or HbsAg. 4. Participant has undergone major surgery within 3 months prior to screening or in whom major surgery is planned during study participation. 5. History of neoplastic disease within 5 years of screening except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. 6. History of hypersensitivity or allergies to Prevotella or Prevotella-containing probiotics or any excipients in the IMP, or has a history of hypersensitivity or allergies to capsule shells. 7. Participant has received live or live-attenuated vaccination within 6 weeks prior to screening or intends to have such a vaccination during the study. Non-live and non-replicating vaccines are permitted if administered at least 14 days before randomisation. 8. Participant has received any investigational drug or experimental procedure within 90 days prior to randomisation. 9. Previous participation in a clinical study of EDP1815. 10. History of drug abuse or current regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening. 11. Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding. 12. Male participant who intends to donate sperm during the course of this study and for a period of 90 days after the last dose. 13. Any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion. 14. Plaque psoriasis limited to the scalp/ hands / feet. 15. Psoriasis flare within 8 weeks prior to screening. 16. Evidence of dermatologic conditions that, would interfere with psoriasis evaluation or the assessment of treatment response. 17. Use of systemic immunosuppressive therapy, systemic medications that could affect psoriasis or its symptoms, or phototherapy within 28 days of randomisation. 18. Treatment with topical medications that could affect psoriasis within 14 days of randomisation. Such topical medications would include, but are not limited to: corticosteroids, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, and tacrolimus. Unmedicated emollients and moisturisers are not excluded and may be used throughout the study (but should be withheld on the day of study visits at which skin assessments of psoriasis are made by the investigator (e.g. PASI). 19. Received any of the following: - Any cell-depleting agent, including rituximab, within 6 months prior to randomisation, or until lymphocyte cell counts return to normal, whichever is longer. - Any other biologic agent, within 6 months prior to randomisation. - Any other investigational drug within 3 months to randomisation. 20. Screening laboratory values showing: - ALT or AST >2xULN. - Elevated serum creatinine, defined for women as serum creatinine =125 µmol/L (1.414 mg/dL) and for men, serum creatinine =135 µmol/L (1.527 mg/dL). - Other clinically significant abnormalities in screening laboratory values that in the opinion of the investigator would make a participant unsuitable for inclusion in the study. 21. History of clinically significant acute cardiac or cerebrovascular even
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the superiority of EDP2939 compared to placebo on the proportion of participants with moderate plaque psoriasis achieving PASI-50;Secondary Objective: • To evaluate the safety and tolerability of EDP2939 in participants with moderate plaque psoriasis • To evaluate the effect of EDP2939 on other measures of clinical efficacy in moderate plaque psoriasis;Primary end point(s): • Efficacy endpoint: proportion of participants achieving PASI-50 at Week 16 ;Timepoint(s) of evaluation of this end point: The primary endpoints will be evaluated at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety endpoints: AEs, SAEs, vital signs, safety laboratory tests, and ECGs Key secondary efficacy endpoints: • Proportion of participants achieving PASI-75 at Week 16 • Proportion of participants achieving PGA 0 or 1 at Week 16 Other secondary efficacy endpoints: • Proportion of participants achieving PASI-90 at Week 16 • Proportion of participants achieving PASI-100 at Week 16 • Mean percentage change in PASI from baseline at Week 16 • Mean absolute change in PASI from baseline at Week 16 • Mean percentage change in PGA*BSA from baseline at Week 16 • Proportion of participants achieving a PGA*BSA-50 (at least 50% improvement) at Week 16 • Proportion of participants achieving a PGA*BSA-75 (at least 75% improvement) at Week 16 • Mean percentage change in BSA from baseline at Week 16 • Proportion of participants achieving a BSA-50 at Week 16 • Proportion of participants achieving a BSA-75 at Week 16 • Proportion of participants achieving a BSA of 3% or less at Week 16 • Mean absolute change in DLQI from baseline at Week 16 • Proportion of participants achieving an improvement in DLQI of =4 points at Week 16, in those with a DLQI of =4 at baseline • Proportion of participants with a DLQI of 0 or 1 at Week 16 • Mean absolute change in PP-NRS from baseline at Week 16 • Proportion of participants achieving an improvement in PP-NRS of =4 points at Week 16, in those with a PP-NRS of =4 at baseline • Mean absolute change in EQ-PSO from baseline at Week 16 • Mean absolute change in fatigue VAS from baseline at Week 16 • Proportion of participants achieving an improvement in fatigue VAS of =3 points at Week 16 from baseline, in those with a score of =3 at baseline ;Timepoint(s) of evaluation of this end point: Timepoint of evaluation is week 16 for efficacy and week 20 for the safety endpoints. | — |
Countries
Bulgaria, Canada, Poland, United Kingdom
Contacts
Public ContactMonika Deme
PPD - Project Delivery
Outcome results
None listed