A Study of the C3 Complement Inhibitor AMY-101 in Adults With Periodontal Disease
赞助:
Amyndas Pharmaceuticals S.A.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 23, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | March 2019 | ||
| 预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change in mean gingival index (MGI)[ Time Frame: Assessed at 28 days after initial treatment ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study of the C3 Complement Inhibitor AMY-101 in Adults With Periodontal Disease | ||
| 正式标题 ICMJE | A Phase 2a Clinical Trial to Assess the Safety and Efficacy of C3 Inhibitor AMY-101, in Adults With Periodontal Disease | ||
| 简要概况 | A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with Periodontal Inflammation The study is a 3-month randomized, double-blind, split-mouth study of adults with existing chronic periodontal inflammation determined by the level of gingival index and bleeding on probing. The primary endpoint of change in gingival index will be evaluated at 21, 28 and 90 days after initial treatment (baseline treatment). Subjects will also be followed at Day 3, 7, 14, 21, 28 and 90 for safety evaluations. Change in bleeding on probing plaque index, pocket depth, clinical attachment level and GCF levels of pro-inflammatory cytokines and complement factors will be assessed as secondary outcome measures. Composition of subgingival biofilm will be assessed as an exploratory endpoint. Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. After clinical assessments and sample collection at baseline, both test and placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1/Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 2020 | ||
| 预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 18-65 years old. 4. Equal to or greater than 18 natural teeth present (excluding third molars). 5. Generalized periodontal inflammation determined by modified gingival index and percent bleeding on probing (MGI≥2.0, BOP ≥ 40%). 6. In good general health as evidenced by medical history. 7. For women of reproductive potential, use of licensed hormonal contraception or barrier methods or abstinence for at least 1 month prior to screening and agreement to use such a method during study participation. 8. For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: 1. Presence of orthodontic appliances (including fixed lingual retainer). 2. A soft or hard tissue tumor of the oral cavity. 3. Carious lesions requiring immediate treatment. 4. Participation in any other clinical study within 30 days of screening or during the study. 5. Antibiotic therapy within the last 30 days. 6. Chronic use (≥3 times/week) of anti-inflammatory medications [e.g., non-steroidal anti-inflammatory drugs (NSAIDs), steroids]. Low dose (<325 mg) aspirin is allowed. 7. Immune compromised subjects (e.g., subjects with HIV infection, neutropenia, complement deficiency, etc.). 8. Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes (irrespective of level of control), rheumatoid arthritis, Crohn's disease, nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g., warfarin [Coumadin] etc.), ongoing cancer treatment either with radiation or chemotherapy. 9. Involvement in the planning or conduct of the study. 10. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subject's study results. 11. Pregnancy or lactation. 12. Uncontrolled chronic diseases (e.g., kidney disease, COPD, pulmonary fibrosis, Hepatitis C) 13. Autoimmune disorders (Down's Syndrome, Sjogren's Disease, Psoriasis, Chediak-Higashi Syndrome) 14. Conditions requiring antibiotic prophylaxis. 15. Periodontal therapy within the past one year. 16. Gross tooth decay, as determined by the investigator. 17. Periodontal or dental abscesses. 18. Root fragments, pericoronitis, endo-perio lesions. 19. Use of cigarettes or other tobacco products (including e-cigarette or recreational drug use) within 1 year before the screening visit. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Amyndas Pharmaceuticals S.A. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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