EUCTR2019-004901-28-HU进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psor
Evelo Biosciences Inc.0 个研究点目标入组 225 人开始时间: 2020年8月31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
- 225
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. 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.
- •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
排除标准
- •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 scre
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