NCT03231280

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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

July 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

July 20, 2017

Last Update Submit

April 17, 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 4 weeks post treatment will be compared between treatment and control groups.

    Baseline, 4 weeks

  • Incidence of Treatment-Emergent Adverse Events

    A summary of Treatment-Emergent Adverse Events will be reported

    Through 4 weeks

Secondary Outcomes (3)

  • Pain

    Baseline, 4 weeks

  • Physical function

    Baseline, 4 weeks

  • Pain

    Baseline, 4 weeks

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 delivered via intra-articular injection

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 27, 2017

Study Start

August 14, 2017

Primary Completion

December 18, 2017

Study Completion

March 27, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)