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

• ClinicalTrials.gov Identifier: NCT03231280
• Recruitment Status: Completed
• First Posted: July 27, 2017
• Last Update Posted: April 19, 2018
• Sponsor: Symic OA Co.
• Collaborator: Nordic Bioscience A/S
• 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 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 14, 2017
• Actual Primary Completion Date: December 18, 2017
• Actual Study Completion Date: March 27, 2018

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 delivered via intra-articular injection

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: 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.
2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 4 weeks ]
   A summary of Treatment-Emergent Adverse Events will be reported

Secondary Outcome Measures :

1. Pain [ Time Frame: Baseline, 4 weeks ]
   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.
2. Physical function [ Time Frame: Baseline, 4 weeks ]
   Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
3. Pain [ Time Frame: 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.

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 A/S

Investigators

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

More Information

• Responsible Party: Symic OA Co.
• ClinicalTrials.gov Identifier: NCT03231280
• Other Study ID Numbers: TP-1803
• First Posted: July 27, 2017
• Last Update Posted: April 19, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Symic OA Co.:

knee

Additional relevant MeSH terms:

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