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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with gingivitis.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety and Microbiology of C16G2 in Adolescent and Adult Dental Subjects

NCT02509845

Dental Caries

COMPLETED PHASE2

Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects

NCT02594254

Dental Caries

COMPLETED PHASE2

Local Minocycline in Patients Under Supportive Periodontal Therapy

NCT04036890

Periodontitis

COMPLETED PHASE4

Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults

NCT02044081

Dental Caries

COMPLETED PHASE2

Long-term Safety of Minocycline in Patients With Gum Disease

NCT00668746

Periodontitis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

AMY-101

Intervention Type DRUG

C3 complement inhibitor

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.

Group Type PLACEBO_COMPARATOR

Water for injection

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMY-101

C3 complement inhibitor

Intervention Type DRUG

Water for injection

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No