NCT04447898

Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine

A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study Assessing the Safety and Immune Response of PPV-06 Vaccine in Patient With Inflammatory Knee Osteoarthritis (KOA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Peptinov SAS · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process. The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	PPV-06 10 μg	Low dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
DRUG	PPV-06 50 μg	High dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
DRUG	Placebo	Placebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112

Timeline

• Start date: 2021-02-18
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2020-06-25
• Last updated: 2024-05-31

Locations

1 site across 1 country: France