NCT03231280: MODIFY2

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

Completed Phase 1, PHASE2 Last updated 19 April 2018

What this trial tests

Phase 1, PHASE2 trial testing SB-061 in Osteoarthritis in 60 participants. Completed in 27 March 2018.

Timeline

14 August 2017

Primary endpoint
18 December 2017

27 March 2018

Quick facts

Lead sponsor	Symic OA Co.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	14 August 2017
Primary completion	18 December 2017
Estimated completion	27 March 2018
Sites	2 locations across Estonia

Drugs / interventions tested

• SB-061
• Placebo

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Symic OA Co.

Who can join

Adults 40 to 85, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8