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NCT Number: NCT02802709

A Trial of SB-061 in Osteoarthritis of the Knee

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CCBR, Tallinn, Estonia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB-061

Device

delivered via intra-articular injection

Placebo

Other

Placebo

Primary outcomes

  1. Pain

    Time frame: 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

    Time frame: Through 3 months

    A summary of Treatment-Emergent Adverse Events will be reported

Secondary outcomes

  1. Pain

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Symic OA Co.

Industry

Collaborators

  • Nordic Bioscience Clinical Development

Registry information

Official study title

A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee

Acronym: MODIFY-OA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2016
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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