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

• ClinicalTrials.gov Identifier: NCT03231280
• Recruitment Status: Completed
• First Posted: July 27, 2017
• Last Update Posted: April 19, 2018
• Sponsor: Symic OA Co.
• Collaborator: Nordic Bioscience A/S
• Information provided by (Responsible Party): Symic OA Co.

Tracking Information

• First Submitted Date: July 20, 2017
• First Posted Date: July 27, 2017
• Last Update Posted Date: April 19, 2018
• Actual Study Start Date: August 14, 2017
• Actual Primary Completion Date: December 18, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2017)

• Pain [ Time Frame: 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 [ Time Frame: Through 4 weeks ]
  A summary of Treatment-Emergent Adverse Events will be reported

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 25, 2017)

• Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

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

Study Arms

• Experimental: SB-061
  SB-061
  Intervention: Device: SB-061
• Placebo Comparator: Placebo
  Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 25, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 27, 2018
• Actual Primary Completion Date: December 18, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Estonia

Administrative Information

• NCT Number: NCT03231280
• Other Study ID Numbers: TP-1803
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Symic OA Co.
• Study Sponsor: Symic OA Co.
• Collaborators: Nordic Bioscience A/S

Investigators

• Study Director: Nathan Bachtell, MD; Symic OA Co.

• PRS Account: Symic OA Co.
• Verification Date: April 2018