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

Osteoarthritis Clinical Trial

— MODIFY2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231280
• Other study ID #: TP-1803
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2017
• Last updated: April 17, 2018
• Start date: August 14, 2017
• Est. completion date: March 27, 2018

Study information

• Verified date: April 2018
• Source: Symic OA Co.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 27, 2018
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• SB-061
delivered via intra-articular injection

Other:
• Placebo
Placebo delivered via intra-articular injection

Locations

Country	Name	City	State
Estonia	CCBR	Tallinn
Estonia	Medita Kliinik	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Symic OA Co.	Nordic Bioscience A/S

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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.	Baseline, 4 weeks
Primary	Incidence of Treatment-Emergent Adverse Events	A summary of Treatment-Emergent Adverse Events will be reported	Through 4 weeks
Secondary	Pain	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.	Baseline, 4 weeks
Secondary	Physical function	Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.	Baseline, 4 weeks
Secondary	Pain	Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.	Baseline, 4 weeks