Clinical trial NCT02761993: Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Treatment Regimen of ST266 in Subjects With Moderate to Severe Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Disease
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
timeFrame: Baseline; 9 months
Secondary outcomes:
measure: Changes in Clinical Attachment Level (CAL)
timeFrame: Baseline, 9 months
measure: Bleeding on Probing (BOP)
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
city: Indianapolis
country: United States
facility: Oral Health Research Institute
state: Indiana
city: Cambridge
country: United States
facility: Forsyth Institute
state: Massachusetts
city: New York
country: United States
facility: Columbia University College of Dental Medicine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook School of Dental Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Dentistry
state: North Carolina
Study officials:
References: