Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605963
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-31
Brief Title:
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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
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 11
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
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 11
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None