A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Device: SB-061; Other: Placebo

• Registration Number: NCT03231280
• Lead Sponsor: Symic OA Co.

Brief Summary

This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

Detailed Description

The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2017-08-14
• Primary Completion: 2017-12-18
• Study Completion: 2018-03-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Femorotibial osteoarthritis of the knee
• Radiological OA Kellgren-Lawrence grade 2 or 3
• WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9

Exclusion Criteria

• Hypersensitivity to medications or to intra-articular injections
• Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
• High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study
• Major surgery or arthroscopy of the target knee within year prior to study
• Planned surgery in the target knee within the next 3 months
• Concomitant inflammatory disease affecting either knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB-061	SB-061	SB-061
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Pain	Baseline, 4 weeks	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Incidence of Treatment-Emergent Adverse Events	Through 4 weeks	A summary of Treatment-Emergent Adverse Events will be reported

Secondary Outcome Measures

Name	Time	Method
Pain	Baseline, 4 weeks	Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Physical function	Baseline, 4 weeks	Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.

Trial Locations

Locations (2)

Medita Kliinik; 🇪🇪 Tartu, Estonia

CCBR; 🇪🇪 Tallinn, Estonia