NCT02761993

Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Treatment Regimen of ST266 in Subjects With Moderate to Severe Periodontitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal disease.

Detailed description

The study is a 9-month, randomized, double-blind, parallel-design study of subjects with existing moderate to severe periodontal disease randomly assigned to one of three groups. The primary endpoint of PD change will be evaluated following 9 months of treatment. Subjects will be followed for 9 months for safety and radiographic evaluations. Subjects who meet inclusion criteria will be randomized to one of three treatment groups. Randomization will be stratified by site and smoker status (never smoked or quit smoking more than two years ago vs. has smoked within the last two years). Randomization will be blocked such that assignment to treatment groups both within sites and within smoker status will be approximately even (1:1:1). Treatment will be initiated after SRP. All subjects will be evaluated at baseline and Days 1, 15, 30, 60, 90, 180, and 270.

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
BIOLOGICAL	ST266	1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
DRUG	Saline (0.9% NaCl)	Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-05-04
• Last updated: 2021-07-22
• Results posted: 2021-06-24

Locations

6 sites across 1 country: United States