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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
C3 complement inhibitor
Placebo
Forsyth Institute
Cambridge, Massachusetts, United States
Change in mean gingival index (MGI)
Time frame: Assessed at 28 days after initial treatment
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
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