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

Primary Purpose

Gingivitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AMY-101

Water for injection

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Age 18-65 years old.
Equal to or greater than 18 natural teeth present (excluding third molars).
Generalized periodontal inflammation determined by modified gingival index and percent bleeding on probing (MGI≥2.0, BOP ≥ 40%).
In good general health as evidenced by medical history.
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.
For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

Presence of orthodontic appliances (including fixed lingual retainer).
A soft or hard tissue tumor of the oral cavity.
Carious lesions requiring immediate treatment.
Participation in any other clinical study within 30 days of screening or during the study.
Antibiotic therapy within the last 30 days.
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.
Immune compromised subjects (e.g., subjects with HIV infection, neutropenia, complement deficiency, etc.).
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.
Involvement in the planning or conduct of the study.
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.
Pregnancy or lactation.
Uncontrolled chronic diseases (e.g., kidney disease, COPD, pulmonary fibrosis, Hepatitis C)
Autoimmune disorders (Down's Syndrome, Sjogren's Disease, Psoriasis, Chediak-Higashi Syndrome)
Conditions requiring antibiotic prophylaxis.
Periodontal therapy within the past one year.
Gross tooth decay, as determined by the investigator.
Periodontal or dental abscesses.
Root fragments, pericoronitis, endo-perio lesions.
Use of cigarettes or other tobacco products (including e-cigarette or recreational drug use) within 1 year before the screening visit.

Sites / Locations

Forsyth Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMY-101 treatment

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in mean gingival index (MGI)

Secondary Outcome Measures

Gingival inflammation

Ulceration in the oral cavity

Oral infections

Changes in mean gingival index

Changes in mean bleeding on probing (BOP)

Changes in mean probing depth (PD)

Number of sites with PD greater or equal to 5 mm

Changes in mean clinical attachment level (CAL)

Changes in plaque index (PI)

Levels of gingival crevicular fluid (GCF)

Levels of proinflammatory mediators in the GCF

Full Information

NCT ID

NCT03694444

First Posted

September 23, 2018

Last Updated

February 19, 2021

Sponsor

Amyndas Pharmaceuticals S.A.

1. Study Identification

Unique Protocol Identification Number

NCT03694444

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 22, 2019 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amyndas Pharmaceuticals S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMY-101 treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

AMY-101

Intervention Description

C3 complement inhibitor

Intervention Type

Other

Intervention Name(s)

Water for injection

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in mean gingival index (MGI)

Time Frame

Assessed at 28 days after initial treatment

Secondary Outcome Measure Information:

Title

Gingival inflammation

Time Frame

Assessed at baseline and Days 3, 7, 14, 21, and 28.

Title

Ulceration in the oral cavity

Time Frame

Assessed at baseline and Days 3, 7, 14, 21, and 28.

Title

Oral infections

Time Frame

Assessed at baseline and Days 3, 7, 14, 21, and 28.

Title

Changes in mean gingival index

Time Frame

Assessed at Days 21 and 90

Title

Changes in mean bleeding on probing (BOP)

Time Frame