NCT02802709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

May 27, 2016

Last Update Submit

January 2, 2018

Conditions

Osteoarthritis

Keywords

knee

Outcome Measures

Primary Outcomes (2)

  • Pain

    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.

    Baseline, 3 months

  • Incidence of Treatment-Emergent Adverse Events

    A summary of Treatment-Emergent Adverse Events will be reported

    Through 3 months

Secondary Outcomes (3)

  • Pain

    Baseline, 3 months

  • Physical function

    Baseline, 3 months

  • Pain

    Baseline, 3 months

Study Arms (2)

SB-061

EXPERIMENTAL

SB-061

Device: SB-061

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

SB-061DEVICE

delivered via intra-articular injection

SB-061
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CCBR

Tallinn, 10128, Estonia

Location

Medita Kliinik

Tartu, 50107, Estonia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Nathan Bachtell, MD

    Symic OA Co.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 16, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

January 4, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)