A Trial of SB-061 in Osteoarthritis of the Knee (MODIFY-OA)

• ClinicalTrials.gov Identifier: NCT02802709
• Recruitment Status: Completed
• First Posted: June 16, 2016
• Last Update Posted: January 4, 2018
• Sponsor: Symic OA Co.
• Collaborator: Nordic Bioscience Clinical Development
• Information provided by (Responsible Party): Symic OA Co.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Device: SB-061; Other: Placebo	Phase 1; Phase 2

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 2 intra-articular injections 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee
• Study Start Date: May 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: Baseline, 3 months ]
   Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 3 months post treatment will be compared between treatment and control groups.
2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 3 months ]
   A summary of Treatment-Emergent Adverse Events will be reported

Secondary Outcome Measures :

1. Pain [ Time Frame: Baseline, 3 months ]
   Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 3 months post treatment will be compared between treatment and control groups.
2. Physical function [ Time Frame: Baseline, 3 months ]
   Change in Patient Global Assessement scores from baseline to 3 months post treatment will be compared between treatment and control groups.
3. Pain [ Time Frame: Baseline, 3 months ]
   Change in Numeric Rating Scale (NRS) of pain from baseline to 3 months post treatment will be compared between treatment and control groups.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Estonia

CCBR

Tallinn, Estonia, 10128

Medita Kliinik

Tartu, Estonia, 50107

Sponsors and Collaborators

Symic OA Co.

Nordic Bioscience Clinical Development

Investigators

• Study Director: Nathan Bachtell, MD; Symic OA Co.

More Information

• Responsible Party: Symic OA Co.
• ClinicalTrials.gov Identifier: NCT02802709
• Other Study ID Numbers: TP-1621
• First Posted: June 16, 2016
• Last Update Posted: January 4, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Symic OA Co.:

knee

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases