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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of PPV-06 Active Immunotherapy in Patients with Inflammatory Knee Osteoarthritis (KOA).

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514388-24-00
Acronym
PPV-06-KOA-201
Enrollment
204
Registered
2024-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Knee osteoarthritis

Brief summary

Absolute change from baseline to Week 54 of the pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (5 items), Absolute change from baseline to Week 54 of the WOMAC physical function subscale score (17 items)

Detailed description

Absolute change from baseline to Week 54 of Synovitis based on 11-point synovitis score, Absolute change from baseline in cartilage thickness (ThC) in the medial femorotibial compartment (MFTC), assessed by MRI at 2 years (Week 104) using quantitative image analysis method

Interventions

DRUGMatching Placebo
DRUGPPV-06

Sponsors

Peptinov
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change from baseline to Week 54 of the pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (5 items), Absolute change from baseline to Week 54 of the WOMAC physical function subscale score (17 items)

Secondary

MeasureTime frame
Absolute change from baseline to Week 54 of Synovitis based on 11-point synovitis score, Absolute change from baseline in cartilage thickness (ThC) in the medial femorotibial compartment (MFTC), assessed by MRI at 2 years (Week 104) using quantitative image analysis method

Countries

Czechia, Denmark, France, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026