PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
brief summary
PPV-06 targets interleukin-6, a key molecule implicated in many inflammatory diseases such osteoarthritis. PPV-06 is used to induce the production of antibodies directed against IL-6. The antibodies produced will neutralize the interleukine-6 involved in the body's inflammatory process. The goal of this clinical trial is to test the safety and efficacy of PPV-06 in participants with Knee Osteoarthritis. The main questions are to evaluate if PPV-06 can reduce pain and improve functioning in participants with knee osteoarthritis, and to evaluate if ¨PPV-06 is safe when administered to participants. Participants will be administered with 6 subcutaneous injections of either PPV-06 or placebo, over a two-year period.
detailed description
This study assesses the safety and efficacy of PPV-06 active immunotherapy versus placebo in patients who have inflammatory osteoarthritis of the knee.
PPV-06 active immunotherapy will be assessed at a dose level of 10 µg. In total, 204 patients will be randomized to receive either IMP or placebo in a ratio 1:1.
Patients will each receive 6 injections of IMP or a placebo during the Double-blind Treatment Period of 104 weeks. For each SC injection, patients will receive the same IMP or Placebo that was administered at the first injection, in a double-blind manner.
The study comprises a total of 13 scheduled on site visits and 5 scheduled phone calls, which are considered appropriate to collect trial data, monitor patients' safety, and support patients' compliance to meet trial objectives.
The overall study duration by patient will be approximately 108 weeks (up to 4 weeks for screening visit and 104 weeks of study treatment). The study comprises:
* Screening period - V1 (up to - 28 days); * Treatment induction immune response period - V2 (D1), V3 (W4), V4; * Maintenance immune response period - V5 (W24), V6, V7 (W44), V8, V9 (W64), V10, V11 (W84), V12 ; * Phone calls between each scheduled visits as per protocol (PC1, PC2, PC3, PC4, PC5); * End of Study visit or Early Termination visit - V13 (W104).
Efficacy evaluations, including pain and physical function assessments, MSK examinations, MRI with contrast, clinical laboratory tests and health related quality of life (such as WOMAC, NRS, PGA, SF-36, EQ-5D-5L, PGIC, PSQI, PSFS, WPAI questionnaires by e-PRO and e-Diary) will be performed.
Safety evaluations, including physical examinations, vital signs, ECGs, X-Ray, Ultrasound (US), MRI with contrast, and clinical laboratory tests will be performed.
Concomitant medication usage will be recorded from the time of screening until the end of the study.
official title
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)