A single intra-articular injection of JTA-004, a combination of human plasma, hyaluronic acid, and clonidine, versus placebo in symptomatic knee osteoarthritis: A Phase 3 trial

Bihlet, AR; Henrotin, Y; Lau, EMC; Alexandersen, P; Godeaux, O; Rovsing, H; Rieger, F; Nicco, C

doi:10.1016/j.joca.2025.09.015

Osteoarthritis

A single intra-articular injection of JTA-004, a combination of human plasma, hyaluronic acid, and clonidine, versus placebo in symptomatic knee osteoarthritis: A Phase 3 trial

Osteoarthritis CartilagePublished 25 Sep 2025Randomised controlled trial

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Authors' conclusion

A single IA injection of JTA-004 was not superior to a saline solution (LSmean difference: -1.50 mm, 95%CI 5.12; 2.12, p= 0.42) or Synvisc-One® (LSmean difference: 2.40, 95% CI: -1.22; 6.02, p=0.20) for the treatment of OA symptoms in the overall study population.

Study context

Population: Participants with symptomatic knee osteoarthritis (OA), Kellgren-Lawrence grade 2 or 3687 (92.1%) completed
Participants: 746 participants

Comparison: Single intra-articular (IA) injection of JTA-004 vs saline (primary hypothesis) and vs hyaluronic acid (HA) comparator Synvisc-One® (secondary hypothesis)
Primary endpoint: Change from baseline in WOMAC pain
Follow-up: Month 3

Methodological detailsmulticentre, Phase 3, double-blind, placebo- and active-controlled, non-inferiority vs active comparator (secondary hypothesis)

Multicentre
Phase 3
Double-blind
Placebo- and active-controlled
Non-inferiority vs active comparator (secondary hypothesis)

Primary result

As reported in the abstract

LSmean difference (95% CI)P value

Between JTA-004 and Synvisc-One®non-inferiority margin Δ = 10 mm

2.40(−1.22 to 6.02)

P = 0.20

Non-inferiority margin 10 as printed, not drawn

JTA-004 vs Placebo: LSmean difference −1.50 mm (95% CI 5.12–2.12); P = 0.42

Secondary outcomes

Main secondary efficacy endpoints (WOMAC function and stiffness, OMERACT-OARSI responder rates, global assessments, rescue medication)

No significant differences in either of the efficacy outcomes of the main study population

Original publication

A single intra-articular injection of JTA-004, a combination of human plasma, hyaluronic acid, and clonidine, versus placebo in symptomatic knee osteoarthritis: A Phase 3 trial. Osteoarthritis Cartilage. Published 25 September 2025. doi:10.1016/j.joca.2025.09.015

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