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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03231280

Acronym

MODIFY2

Enrollment

Registered

2017-07-27

Start date

2017-08-14

Completion date

2018-03-27

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

knee

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.

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.

Interventions

DEVICESB-061

delivered via intra-articular injection

OTHERPlacebo

Placebo delivered via intra-articular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026