---
title: A Trial of SB-061 in Osteoarthritis of the Knee
nct_id: NCT02802709
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Symic OA Co.
study_type: INTERVENTIONAL
primary_condition: Osteoarthritis
countries: Estonia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02802709.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02802709"
ct_last_update_post_date: 2018-01-04
last_seen_at: "2026-05-12T06:36:40.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Trial of SB-061 in Osteoarthritis of the Knee

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

**NCT ID:** [NCT02802709](https://clinicaltrials.gov/study/NCT02802709)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Symic OA Co.
- **Collaborators:** Nordic Bioscience Clinical Development
- **Conditions:** Osteoarthritis
- **Start Date:** 2016-05
- **Completion Date:** 2017-06
- **CT.gov Last Update:** 2018-01-04

## 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 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **SB-061** (EXPERIMENTAL) — SB-061
- **Placebo** (PLACEBO_COMPARATOR) — Placebo

## Interventions

- **SB-061** (DEVICE) — delivered via intra-articular injection
- **Placebo** (OTHER) — Placebo

## Primary Outcomes

- **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.
- **Incidence of Treatment-Emergent Adverse Events** _(time frame: Through 3 months)_ — A summary of Treatment-Emergent Adverse Events will be reported

## Secondary Outcomes

- **Pain** _(time frame: Baseline, 3 months)_
- **Physical function** _(time frame: Baseline, 3 months)_
- **Pain** _(time frame: Baseline, 3 months)_

## Locations (2)

- CCBR, Tallinn, Estonia
- Medita Kliinik, Tartu, Estonia

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ccbr|tallinn||estonia` — added _(2026-05-12)_
- `locations.medita kliinik|tartu||estonia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02802709.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02802709*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*