A Study of the C3 Complement Inhibitor AMY-101 in Adults With Gingivitis
Status:
Completed
Trial end date:
2020-10-30
Target enrollment:
Participant gender:
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.