A Study of the C3 Complement Inhibitor AMY-101 in Adults With Periodontal Disease

Sponsor:

Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

September 23, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

March 2019

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in mean gingival index (MGI)[ Time Frame: Assessed at 28 days after initial treatment ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Gingival inflammation[ Time Frame: Assessed at baseline and Days 3, 7, 14, 21, and 28. ]
Ulceration in the oral cavity[ Time Frame: Assessed at baseline and Days 3, 7, 14, 21, and 28. ]
Oral infections[ Time Frame: Assessed at baseline and Days 3, 7, 14, 21, and 28. ]
Changes in mean gingival index[ Time Frame: Assessed at Days 21 and 90 ]
Changes in mean bleeding on probing (BOP)[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Changes in mean probing depth (PD)[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Number of sites with PD greater or equal to 5 mm[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Changes in mean clinical attachment level (CAL)[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Changes in plaque index (PI)[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Levels of gingival crevicular fluid (GCF)[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]
Levels of proinflammatory mediators in the GCF[ Time Frame: Assessed at baseline and 21, 28 and 90 days ]

Descriptive Information

Brief Title ^ICMJE

A Study of the C3 Complement Inhibitor AMY-101 in Adults With Periodontal Disease

Official Title ^ICMJE

A Phase 2a Clinical Trial to Assess the Safety and Efficacy of C3 Inhibitor AMY-101, in Adults With Periodontal Disease

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1/Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: AMY-101
C3 complement inhibitor
Other: Water for injection
Placebo

Study Arms

Active Comparator: AMY-101 treatment
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. In the AMY-101 treatment arm after clinical assessments and sample collection at baseline, test treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14.
Placebo Comparator: Placebo
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. In the placebo arm, after clinical assessments and sample collection at baseline, placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 2020

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Amyndas Pharmaceuticals S.A.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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