PPV-06 Vaccine in Inflammatory Knee Osteoarthritis

A Phase 2 study testing PPV-06 in people with Osteoarthritis, Knee, run by Peptinov SAS at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: PPV-06
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 1 siteFrance
Study dates: Apr 2027to Dec 2030
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
Known presence of pre-existing MRI-based findings warranting exclusion in accordance with the ROAMES criteria, such as rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic oste-oarthritis, severe bone on bone osteoarthritis, or knee pain attributable to disease other than osteoarthritis, or as assessed by X-Ray, based on Central imaging Reading at Screening Visit and before the Baseline Visit.
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.
History of severe allergic or anaphylactic reactions.
Known infection of human immunodeficiency virus (HIV), or known current acute or chronic hepatitis B or C infection.
Unstable or poorly controlled blood pressure which, in the opinion of the inves-tigator, would put the patient at risk of severe adverse blood pressure increases upon IMP administration.
History of malignancy within 5 years prior to the Screening visit, with the ex-ception of basal cell carcinoma.
History of either active TB or latent TB with inadequate course of anti-tuberculous prophylaxis.
Contraindications to an MRI (including the gadolinium contrast with a Glo-merular Filtration Rate (GFR) below 60 mL/min) of the index knee or has a pacemaker or any other implanted electronic devices. Claustrophobic patient with impossibility to under-go an MRI.
Evidence or history of severe psychiatric illness/disorder during 3 years prior to the Screening Visit that, in the investigator's opinion, may affect safety or efficacy assess-ments or may compromise the patient's safety during trial participation.
Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site

CIC Cochin
Paris
François Rannou, MD, 0033 1 58 41 25 48, francois.rannou@aphp.fr

Other trials in France

About this 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)

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.

Read the 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.

Conditions: Osteoarthritis, Knee
Being tested: PPV-06, Placebo
Keywords: Inflammatory osteoarthritis, Immunotherapy, Interleukine-6
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPV-06Drug
6 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84
PlaceboDrug
6 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84

Study groups in NCT06605963
Study group	Role	What they receive
PPV-06	Experimental	PPV-06 10 μg + Montanide™ ISA 51 VG in subcutaneous administration Receives: Drug: PPV-06
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Measured: From Baseline to Week 54

Secondary outcomes (5)

To evaluate the efficacy of PPV-06 on key structural features of knee Osteoarthritis
Absolute change from baseline in cartilage thickness (ThC) in the medial femorotibial compartment (MFTC)
Measured: From Baseline to Week 104
Cartilage thickness
Absolute change from baseline in cartilage thickness (ThC) assessed by MRI at 1 and 2 years (W54 and W104) using quantitative image analysis method
Measured: From Baseline to Week 104
Safety and Tolerability of PPV-06
Incidence of Adverse Events of Special Interest (AESI).
Measured: From Baseline to Week 104
To evaluate the efficacy of PPV-06 on key inflammation features of knee Osteoarthritis
Absolute Change from baseline to Week 54 of Synovitis based on Rapid OsteoArthritis MRI Eligibility Score (ROAMES) 11-point synovitis score
Measured: From Baseline to Week 54
Western Ontario and McMaster University total score
Absolute Change of the Western Ontario and McMaster University (WOMAC) total score
Measured: From baseline to Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2027Dec 2030

First posted20 Sep 2024
Study startApr 2027 (estimated)
Primary completionDec 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multicenter Study
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 204 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06605963
Sponsor's protocol ID: PPV-06-KOA-201
Other IDs: 2024-514388-24
Status last verified: Oct 2026
First submitted: 31 May 2024
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06605963
Acronym / sponsor ID: PPV-06-KOA-201
Conditions: Osteoarthritis, Knee
Keywords: Inflammatory osteoarthritis, Immunotherapy, Interleukine-6
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 204 participants (estimated)
Lead sponsor: Peptinov SASIndustry (pharma, biotech, devices)
Study start: Apr 2027 (estimated)
Primary completion: Dec 2030 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 20 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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).

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multicenter Study

Arm	Type	Receives
PPV-06	Experimental	Drug: PPV-06PPV-06 10 μg + Montanide™ ISA 51 VG in subcutaneous administration
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PPV-066 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84	Drug	PPV-06
Placebo6 subcutaneous injections at Day 1, Week 4, Week 24, Week 44, Week 64, Week 84	Drug	Placebo

Primary outcome

To evaluate the efficacy of PPV-06 on pain in participants with knee Osteoarthritis
Time frame: From Baseline to Week 54
Absolute change from baseline to Week 54 of the pain subscale score of the Western Ontario and McMaster University scale (WOMAC)
To evaluate the efficacy of PPV-06 on physical functioning in participants with knee Osteoarthritis
Time frame: From Baseline to Week 54
Absolute change from baseline to Week 54 of the Western Ontario and McMaster University (WOMAC) physical function subscale score

5 secondary outcomes

To evaluate the efficacy of PPV-06 on key structural features of knee Osteoarthritis
Time frame: From Baseline to Week 104
Cartilage thickness
Time frame: From Baseline to Week 104
Safety and Tolerability of PPV-06
Time frame: From Baseline to Week 104
To evaluate the efficacy of PPV-06 on key inflammation features of knee Osteoarthritis
Time frame: From Baseline to Week 54
Western Ontario and McMaster University total score
Time frame: From baseline to Week 54

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

CIC Cochin

Paris, France

0033 1 58 41 25 48

francois.rannou@aphp.fr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PPV-06 in people with Osteoarthritis, Knee, run by Peptinov SAS at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of PPV-06 on pain in participants with knee Osteoarthritis (time frame: From Baseline to Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.