PPV-06 Vaccine in Inflammatory Knee Osteoarthritis

NCT06605963 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: PPV-06-KOA-2012024-514388-24
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Inflammatory osteoarthritis; Immunotherapy; Interleukine-6

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of PPV-06 on pain in participants with knee Osteoarthritis

  Absolute change from baseline to Week 54 of the pain subscale score of the Western Ontario and McMaster University scale (WOMAC)

  From Baseline to Week 54

• To evaluate the efficacy of PPV-06 on physical functioning in participants with knee Osteoarthritis

  Absolute change from baseline to Week 54 of the Western Ontario and McMaster University (WOMAC) physical function subscale score

  From Baseline to Week 54

Secondary Outcomes (5)

• To evaluate the efficacy of PPV-06 on key structural features of knee Osteoarthritis

  From Baseline to Week 104

• Cartilage thickness

  From Baseline to Week 104

• Safety and Tolerability of PPV-06

  From Baseline to Week 104

• To evaluate the efficacy of PPV-06 on key inflammation features of knee Osteoarthritis

  From Baseline to Week 54

• Western Ontario and McMaster University total score

  From baseline to Week 54

Other Outcomes (1)

• Immune response and development of antibodies to treatment with PPV-06

  From Baseline to Week 104

Study Arms (2)

PPV-06

EXPERIMENTAL

PPV-06 10 μg + Montanide™ ISA 51 VG in subcutaneous administration

Drug: PPV-06

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PPV-06 DRUG

6 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84

PPV-06

Placebo DRUG

6 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has given written informed consent to participate.
• Male or female, aged at least 40 years old.
• BMI between 22 to 35kg/m² at Screening visit.
• Diagnosis of osteoarthritis of the index knee based on American College of Rheumatology (ACR) criteria and functional capacity class of I-III, with a Kellgren-Lawrence grade \[KLG\] 2 or 3.
• OARSI medial Joint Space Narrowing (mJSN) Grade 1 or 2 of the index knee joint, confirmed by a semi-flexed or fixed flexion weight-bearing X-Ray performed at Screening visit, and assessed by Central Reader.
• Evidence during the Screening visit of synovitis in the index knee based on ultrasound as described in the Ultrasound Doppler manual.
• Evidence of moderate to severe Synovitis on 11-point synovitis (based on Guermazi et al. score), as assessed by Rapid OA MRI Eligibility Score (ROAMES(1)), per-formed during the Screening visit and assessed by Central Reader.
• Insufficient pain relief with standard of care (i.e. non-pharmacological treat-ments, systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics) for symptomatic OA in the index knee within 6 months prior to the Screening vis-it.
• Pain at index knee for the majority of days (\>50%) during the preceding month prior to the Screening Visit.
• At Screening Visit 1a, participant reports that their typical OA knee pain in one or both knees when not using medication is ≥ 4 out of 10.
• WOMAC pain subscale score (5 items) in the range \[≥4 and ≤8\], using the 11-point (0-10) NRS for the index knee at Screening and Baseline visits.
• Participant is willing to discontinue all pain medications for OA except rescue medication (pa-racetamol), to adhere to the restricted use of concomitant treatments and not use prohibited pain medications throughout the clinical trial.

You may not qualify if:

• Participant had an administration of NSAID (topical, tablets) or Cox-2 Inhibitors within 2 weeks prior to the Baseline visit.
• Injection of either corticosteroid or intra-articular (IA) Visco-supplementation (i.e., hyaluronic acid) into the index knee within 1 month of Screening.
• Injection of platelet-rich plasma (PRP) into the index knee within 6 months of Screening.
• Application of topical capsaicin on the index knee within 1 month of Screening.
• Past joint replacement surgery of the index knee.
• History of significant trauma or surgery (e.g., open or arthroscopic) to the in-dex knee within 12 months of Screening.
• Scheduled surgery except dental surgery during the clinical trial period.
• Any known active infection, including suspicion of intra-articular infection, ul-cer or open wound anywhere on the index knee.
• Periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, tendinitis, soft tissue tenderness, or subacute/acute pain from injury in the index knee.
• Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the index knee (varus \>10°, valgus \>10°) by X-Ray as assessed by Central Readers at Screening Visit.
• Other conditions that could affect trial endpoint assessments of the index knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, ankylosing spondyli-tis, gout or pseudogout, inflammatory bowel disease related arthropathy, peripheral neuropathy, lupus erythematosus, significant skin conditions such as abscesses, acromegaly, metabolic joint diseases and fibromyalgia.
• Neuropathic pain as assessed by PainDETECT questionnaire with a score of at least 18 at Screening Visit.
• Systemic (except inhaled) immunosuppressant agent within 6 months prior to trial medication administration.
• Current clinically significant disease(s) or condition(s) (including clinically significant cardiovascular disease and/or significant pain in other areas) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the patient's participation in the full duration of the trial.
• Major bleeding disorder encompassing, but not limited to coagulopathy and any current antithrombotic and anticoagulant events.

Sponsors & Collaborators

• Peptinov SAS: lead

Study Sites (1)

CIC Cochin

Paris, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multicenter Study

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: September 20, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)