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

Symic Bio

Status and phase

Completed

Phase 2

Phase 1

Conditions

Osteoarthritis

Treatments

Device: SB-061

Other: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02802709

TP-1621

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No 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