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

Sponsor

Symic OA Co. (Industry)

Overall Status

Completed

CT.gov ID

NCT03231280

Collaborator

Nordic Bioscience A/S (Industry)

Enrollment

Locations

Arms

7.4

Actual Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

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 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

Anticipated 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 :

Aug 14, 2017

Actual Primary Completion Date :

Dec 18, 2017

Actual Study Completion Date :

Mar 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

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

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

Pain [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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 A/S

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:

NCT03231280

Other Study ID Numbers:

TP-1803

First Posted:

Jul 27, 2017

Last Update Posted:

Apr 19, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Symic OA Co.

knee

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 19, 2018