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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Estonia
Study Type
Interventional
Intervention
SB-061
Placebo
Sponsored by
Symic OA Co.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CCBR
  • Medita Kliinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SB-061

Placebo

Arm Description

SB-061

Placebo

Outcomes

Primary Outcome Measures

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.
Incidence of Treatment-Emergent Adverse Events
A summary of Treatment-Emergent Adverse Events will be reported

Secondary Outcome Measures

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.
Physical function
Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Pain
Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.

Full Information

First Posted
July 20, 2017
Last Updated
April 17, 2018
Sponsor
Symic OA Co.
Collaborators
Nordic Bioscience A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03231280
Brief Title
A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symic OA Co.
Collaborators
Nordic Bioscience A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SB-061
Arm Type
Experimental
Arm Description
SB-061
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Device
Intervention Name(s)
SB-061
Intervention Description
delivered via intra-articular injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo delivered via intra-articular injection
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
Baseline, 4 weeks
Title
Incidence of Treatment-Emergent Adverse Events
Description
A summary of Treatment-Emergent Adverse Events will be reported
Time Frame
Through 4 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
Baseline, 4 weeks
Title
Physical function
Description
Change in Patient Global Assessement scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Time Frame
Baseline, 4 weeks
Title
Pain
Description
Change in Numeric Rating Scale (NRS) of pain from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Bachtell, MD
Organizational Affiliation
Symic OA Co.
Official's Role
Study Director
Facility Information:
Facility Name
CCBR
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Medita Kliinik
City
Tartu
ZIP/Postal Code
50107
Country
Estonia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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