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

• Sponsor: Symic OA Co. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02802709
• Collaborator: Nordic Bioscience Clinical Development (Other)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 45
• Patients Per Site Per Month: 3.5

Study Details

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
• Anticipated 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 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Jun 1, 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 [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 [Through 3 months]

   A summary of Treatment-Emergent Adverse Events will be reported

Secondary Outcome Measures

1. Pain [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 [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 [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

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	CCBR	Tallinn		Estonia	10128
2	Medita Kliinik	Tartu		Estonia	50107

Sponsors and Collaborators

• Symic OA Co.
• Nordic Bioscience Clinical Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Symic OA Co.
• ClinicalTrials.gov Identifier: NCT02802709
• Other Study ID Numbers: TP-1621
• First Posted: Jun 16, 2016
• Last Update Posted: Jan 4, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Symic OA Co.: knee
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jan 4, 2018