NCT03694444

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

Completed Phase 1, PHASE2 Last updated 21 February 2021

What this trial tests

Phase 1, PHASE2 trial testing AMY-101 in Gingivitis in 39 participants. Completed in 30 October 2020.

Timeline

22 July 2019

Primary endpoint
30 August 2020

30 October 2020

Quick facts

Lead sponsor	Amyndas Pharmaceuticals S.A.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	22 July 2019
Primary completion	30 August 2020
Estimated completion	30 October 2020
Sites	1 location across United States

Drugs / interventions tested

• AMY-101 — full drug profile →
• Water for injection — full drug profile →

Conditions studied

• Gingivitis — all drugs for Gingivitis →

Sponsor

Amyndas Pharmaceuticals S.A.

Who can join

Adults 18 to 65, any sex, with Gingivitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New insights into the immune functions of complement.
   Reis ES, Mastellos DC, Hajishengallis G, Lambris JD. · · 2019 · cited 357× · PMID 31048789 · DOI 10.1038/s41577-019-0168-x
2. Clinical promise of next-generation complement therapeutics.
   Mastellos DC, Ricklin D, Lambris JD. · · 2019 · cited 255× · PMID 31324874 · DOI 10.1038/s41573-019-0031-6
3. Host Modulation and Treatment of Periodontal Disease.
   Balta MG, Papathanasiou E, Blix IJ, Van Dyke TE. · · 2021 · cited 122× · PMID 33655803 · DOI 10.1177/0022034521995157
4. Rationale for targeting complement in COVID-19.
   Polycarpou A, Howard M, Farrar CA, Greenlaw R, et al · · 2020 · cited 98× · PMID 32559343 · DOI 10.15252/emmm.202012642
5. <i>Porphyromonas gingivalis</i>: Immune subversion activities and role in periodontal dysbiosis.
   Hajishengallis G, Diaz PI. · · 2020 · cited 73× · PMID 33344104 · DOI 10.1007/s40496-020-00249-3
6. Targeting the complement system in neuromyelitis optica spectrum disorder.
   Asavapanumas N, Tradtrantip L, Verkman AS. · · 2021 · cited 64× · PMID 33513036 · DOI 10.1080/14712598.2021.1884223
7. Phase IIa clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation.
   Hasturk H, Hajishengallis G, Forsyth Institute Center for Clinical and Translational Research staff, Lambris JD, et al · · 2021 · cited 62× · PMID 34618684 · DOI 10.1172/jci152973
8. COVID‑19 and ischemic stroke: Mechanisms of hypercoagulability (Review).
   Zhang S, Zhang J, Wang C, Chen X, et al · · 2021 · cited 59× · PMID 33448315 · DOI 10.3892/ijmm.2021.4854