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

NCT02761993 | Completed Phase 2 Results

• 1 other identifier: ST266-PERIO-201
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline

  The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.

  Baseline; 9 months

Secondary Outcomes (2)

• Changes in Clinical Attachment Level (CAL)

  Baseline, 9 months

• Bleeding on Probing (BOP)

  Baseline and 9 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).

Biological: ST266

Group 2

ACTIVE COMPARATOR

Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).

Biological: ST266

Group 3

PLACEBO COMPARATOR

Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.

Drug: Saline (0.9% NaCl)

Interventions

ST266 BIOLOGICAL

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).

Group 1; Group 2

Saline (0.9% NaCl) DRUG

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).

Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed, written informed consent prior to participation in any study-related procedures.
• Good general health as evidenced by medical history.
• Between 18 and 85 years of age at time of informed consent signature.
• Male or female.
• Minimum of 18 teeth, excluding third molars.
• Having moderate to severe periodontal disease according to AAP definition (at least 6 teeth ≥6 mm PD and ≥3 mm CAL at baseline).
• Having \>30 percent bleeding sites upon probing.
• Willing to abstain from chewing gums and other mouth rinses for the study duration.
• Ability and willingness to attend all study visits and comply with all study visits and comply with all study procedures and requirements.
• Willingness to abstain from routine dental care.
• For women with reproductive potential, willingness to use highly effective contraception (e.g. licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner).

You may not qualify if:

• Presence of orthodontic appliances.
• A soft or hard tissue tumor of the oral cavity.
• Any dental condition that requires immediate treatment, such as carious lesions.
• Participation in any other clinical study within 30 days of screening or during the study.
• Pregnancy or lactation. If a subject meets this criterion, she may be rescreened for study participation when she no longer meets this criterion.
• Antibiotic therapy within the last 30 days.
• Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily) is allowed.
• Immunocompromised subjects.
• Subjects with cancer or a history of cancer within the last 5 years of screening.
• Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes, nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin \[Coumadin\] etc.).
• 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.
• Previous randomization for treatment in the present study

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead

Study Sites (6)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294, United States

Location

Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

Location

Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

Columbia University College of Dental Medicine

New York, New York, 10032, United States

Location

Stony Brook School of Dental Medicine

Stony Brook, New York, 11794-8703, United States

Location

University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: David Steed, MD
• Organization: Noveome Biotherapeutics, Inc

dsteed@noveome.com

4124029913

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 22, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-07

Locations

US (6)