Mild, moderate and severe atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
EVELO Biosciences Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must have given 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 aged = 18 and = 75 years old at the time of informed consent. 3. A diagnosis of atopic dermatitis (AD) meeting Hanifin and Rajka criteria for AD at screening with patient- or clinician- reported disease duration of at least 6 months. 4. Have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1: i. An IGA of 2, 3 or 4 on the vIGA scale, and; ii. A BSA of =5%, and; iii. An EASI score of =6. 5. All participants must agree to use a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel or ointment twice daily (or more, as needed) for at least 14 consecutive days immediately prior to randomization and must continue this treatment twice daily throughout the trial. 6. Meet the following contraception criteria: i. Male participants: i. A male participant must agree to use contraception 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. ii. Female participants: i. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. Not a WOCBP or 2. A WOCBP who agrees to follow the contraceptive guidance of the protocol during their 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. 7. Agrees to not increase their usual sun exposure significantly 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 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: 1. Atopic dermatitis limited to the hands and/or feet and/or scalp. 2. Have been in a clinical trial for EDP1815 within the 12 weeks prior to signing of ICF. 3. History of active skin infection within 14 days prior to randomization. 4. Evidence of dermatologic conditions that may, in the opinion of the investigator, interfere with AD evaluation or the assessment of treatment response. 5. Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization. 6. Previously received any biologic agent for AD and either was: a. Unresponsive to biologic agent, or b. Responsive to biologic agent and received this therapy within 3 months or 5 half-lives prior to randomization, whichever is longer. 7. Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization. 8. Received any investigational or licensed biologic agent for conditions other than AD: a. Any cell-depleting agent, including rituximab, within 6 months prior to randomization, or until lymphocyte cell counts return to normal, whichever is longer. b. Any other biologic agent, within 3 months or 5 half-lives prior to randomization, whichever is longer. 9. Gastrointestinal tract disease (e.g., short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time. 10. Active inflammatory bowel disease. 11. Ongoing acute or chronic infectious disease. Patients with hepatitis B, hepatitis C, and HIV may be enrolled provided that the disease is adequately controlled and/or is in remission. 12. 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. 13. Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window. 14. Screening Labs: For women, serum creatinine =125 µmol/L (1.414 mg/dL); for men, serum creatinine =135 µmol/L (1.527 mg/dL). 15. Screening Labs: ALT or AST >2 × ULN. 16. History of clinically significant acute cardiac or cerebrovascular event within 6 months of signing ICF (includes stroke, transient ischemic attack, and coronary heart disease [angina pectoris, myocardial infarction, heart failure, revascularization procedures]). 17. History of active substance (drug and/or alcohol) abuse within the prior 12 months. This does not include the current or prior use of cannabis. 18. In the opinion of the Investigator, evidence of clinically important cardiac conduction abnormalities as judged by the screening ECG. 19. Hypersensitivity to P histicola or to any of the excipients. 20. 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 signing of ICF and whose treating physicians consider them to be mentally stable may be enrolled. 21. Recen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary comparison of interest is the mean difference between EDP1815 and placebo in the percentage change from baseline in EASI score at Week 12. The primary trial objective is to show superiority of EDP1815 over placebo. The primary comparison will be made while on treatment but without regard to treatment compliance or any changes in background or rescue therapy. ;Secondary Objective: 1. To evaluate the clinical benefit of EDP1815 in the treatment of atopic dermatitis. 2. To evaluate the safety and tolerability of EDP1815.;Primary end point(s): The primary efficacy endpoint of the study is the effect of EDP1815 on the percent change in the Eczema Area and Severity Index (EASI) score from baseline to Week 12.;Timepoint(s) of evaluation of this end point: The primary endpoints will be evaluated at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean absolute change and percentage change from baseline in EASI Score • Percentage of Participants Achieving EASI-50 • Percentage of Participants Achieving EASI-75 • Percentage of Participants Achieving EASI-90 • Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a =2 Point Improvement from baseline • Percentage of Participants Achieving IGA of 0 or 1 • Percentage of Participants Achieving IGA of 0 [Time Frame: Week 12 and 16] • Mean absolute change and percentage change from baseline in IGA*BSA • Mean absolute change and percentage change from baseline in BSA • Percentage of Participants Achieving BSA-50 • Percentage of Participants Achieving BSA-75 • Percentage of Participants Achieving BSA reduction to 3% BSA or less • Mean absolute change and percentage change from baseline in SCORing Atopic Dermatitis (SCORAD) • Percentage of Participants Achieving SCORAD-50 • Percentage of Participants Achieving SCORAD-75 • Mean absolute change and percentage change from baseline in DLQI • Percentage of Participants achieving a reduction of =4 in the DLQI, of those with a score of =4 at baseline [Time Frame: Week 12 and 16] • Mean absolute change from baseline in worst Pruritus-NRS • Percentage of Participants achieving a reduction of =2 in the worst Pruritus-NRS, of those with a score of =2 at baseline • Percentage of Participants achieving a reduction of =4 in the worst Pruritus-NRS, of those with a score of =4 at baseline [Time Frame: Week 12 and 16] • Mean absolute change from baseline in SD-NRS score • Percentage of Participants achieving a reduction of =2 in SD-NRS score, of those with a score of =2 at baseline Mean absolute change and percentage change from baseline in Patient Oriented Eczema Measure (POEM) • Percentage of Participants achieving a reduction of =4 in the POEM score, of those with a score of =4 at baseline • Number of courses of rescue therapy per Participant • Num | — |
Countries
Australia, Bulgaria, Canada, Germany, Poland, United States
Contacts
Public ContactEzio Parchitelli
PPD - Project Delivery
Outcome results
None listed