Health TrialsbyHealthPanel

Efficacy and Safety of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

ConditionsKnee Arthritis OsteoarthritisKnee Arthritis, OsteoarthritisKnee ArthritisKnee Arthritis DiseaseOsteo Arthritis of the KneeOsteoarthritic Knee PainOsteoarthritis (OA) of the KneeOsteo Arthritis KneePain (Knee)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGenascence Corporation

About this trial

The goal of this clinical trial is to learn if GNSC-001 works to treat knee osteoarthritis in adults. It will also learn about the safety of GNSC-001. The main questions it aims to answer are:

1. Does GNSC-001 lower daily knee joint pain and improve function in participants? 2. What medical problems do participants have when taking GNSC-001?

Researchers will compare GNSC-001 to a placebo (a look-alike substance that contains no drug) to see if GNSC-001 works to treat knee osteoarthritis.

Participants will:

1. Receive a single injection of immune-modulation, and GNSC-001 or a placebo, in their knee 2. Take an oral immune-modulating pill every day for the first 22 days 3. Visit the clinic at least 9 times over 2 years for checkups and tests 4. Keep a diary of their symptoms and the number of times they use a rescue medication

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

OA in the target knee confirmed by radiograph and with a Kellgren-Lawrence (KL) score of 2 or 3

OA symptoms affecting the target knee present for at least 6 months

NRS pain score 5-9 (0-10 scale) in the target knee within the 24 hours prior to the time of consent

Synovitis and/or effusion detectable on imaging

Disqualifiers

Body mass index (BMI) > 38 kg/m2

NRS pain score in other (non-target) knee ≥ 4

Large effusion, substantial malalignment, structural compromise, prior partial or total joint replacement of target knee

Surgery on the target knee within the 6 months prior to screening or the anticipated need for treatment of either knee prior to the Month 12 Visit.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gene Therapy GNSC-001

    Drug

    Single intra-articular injection into target knee

  • Placebo

    Drug

    Single intra-articular injection into target knee

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: GNSC-001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in OA pain as assessed by the Weekly Average of Daily Pain (WADP) Numeric Rating Scale (NRS) at Week 52

Time frame
Baseline and Week 52
2

Change from baseline in the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 52

Time frame
Baseline and Week 52
3

Incidence and severity of treatment emergent adverse events (TEAEs), events of clinical interest (ECIs), and serious adverse events (SAEs)

Time frame
From enrollment to the end of study at 104 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genascence Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: