EUCTR2021-001805-63-BG进行中（未招募）1 期
A phase 2, multicenter, double-blind, placebo-controlled, multiple-cohort study investigating the effect of EDP1815 in participants for the treatment of mild, moderate and severe atopic dermatitis
EVELO Biosciences Inc0 个研究点目标入组 450 人开始时间: 2021年8月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •A cap will be set for each of the three IGA severity grades. When this cap is reached, Sponsor will notify sites that participants with severity score at Screening and/or Day 1 matching the closed stratum should be considered ineligible according to Inclusion Criterion 4i.
- •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 354
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1. Atopic dermatitis limited to the hands and/or feet and/or scalp.
- •2. Have been in a clinical trial for EDP1815 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 mental or psychiatric disorder, which, in the opinion of the
- •Investigator or Sponsor, would make the participant unsuitable for
- •inclusion or could interfere with the participant participating in or
- •completing the study.
- •21. Recent major surgery within 3 months of signing the ICF, or major surgery planned durin
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