A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee (MODIFY2)

A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: SB-061; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10128
    • CCBR
  • Tartu, Estonia, 50107
    • Medita Kliinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo delivered via intra-articular injection
Experimental: SB-061	Device: SB-061; delivered via intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	Baseline, 4 weeks
Incidence of Treatment-Emergent Adverse Events	A summary of Treatment-Emergent Adverse Events will be reported	Through 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.	Baseline, 4 weeks
Physical function	Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.	Baseline, 4 weeks
Pain	Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Symic OA Co.
• Collaborators: Nordic Bioscience A/S
• Investigators: Study Director: Nathan Bachtell, MD, Symic OA Co.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TP-1803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No