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A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients with Primary Knee Osteoarthritis

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524668-39-00
Enrollment
75
Registered
2026-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The change from baseline for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score (normalized 0–100) at 3 months., Incidence and severity of Adverse Events (AEs), treatment disruptions/ discontinuations and evaluation of safety laboratory values up to 6 months.

Detailed description

The change from baseline of the WOMAC Pain+Function score at 3 months., The change from baseline for the WOMAC Function score at 3 months., The change from baseline of the WOMAC Pain score at 3 months., The change from baseline of the WOMAC Total score at 6 months., The change from baseline of the WOMAC Pain+Function score at 6 months., The change from baseline of the WOMAC Pain score at 6 months., The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 months., The change from baseline of the ADP-NRS at 6 months.

Interventions

DRUGAllocetra-OTS
DRUGMatching placebo (vehicle)

Sponsors

Enlivex Therapeutics Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The change from baseline for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score (normalized 0–100) at 3 months., Incidence and severity of Adverse Events (AEs), treatment disruptions/ discontinuations and evaluation of safety laboratory values up to 6 months.—

Secondary

MeasureTime frame
The change from baseline of the WOMAC Pain+Function score at 3 months., The change from baseline for the WOMAC Function score at 3 months., The change from baseline of the WOMAC Pain score at 3 months., The change from baseline of the WOMAC Total score at 6 months., The change from baseline of the WOMAC Pain+Function score at 6 months., The change from baseline of the WOMAC Pain score at 6 months., The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 months., The change from baseline of the ADP-NRS at 6 months.—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 14, 2026