CompletedPhase 2

Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint

Australia134 participantsStarted 2021-01-11

Plain-language summary

The study is designed to evaluate the efficacy, safety and tolerability of OLP-1002 Subcutaneous (SC) injections for reducing moderate to severe pain due to osteoarthritis in a hip and/or knee joint.

Who can participate

Age range35 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to provide written informed consent prior to any study-related procedures being performed in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) and local regulations.
✓. Male or female aged ≥ 35 years to ≤ 70 years as of the date of enrolment into the study
✓. No history of cardiac disease including arterial or venous thrombi, cardiac arrhythmia, myocardial infarction, admission to hospital for unstable angina, cardiac angioplasty or stent implantation within 90 days prior to Screening.
✓. Body mass index (BMI) ≥ 18 kg/m2 \< 40 kg/m2 at Screening.
✓. Pain in hip or knee joints, every day for at least 1-month during the 3 months prior to Screening.
✓. Diagnosis of Osteoarthritis (OA) of the index hip or knee: moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria with Kellgren Lawrence x-ray grade of at least 2, as diagnosed by the radiologist or rheumatologist.
✓. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain score of ≥ 10 out of 20 in the index hip or knee at Screening.
✓. Willing and able to provide their historical use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over-the-counter (OTC) per recommendation of a physician or prescribed during the past 6 months (the pain in the target knee and/or hip required).

Exclusion criteria

✕. Known history or current symptomatic heart failure as per New York Heart Association (NYHA) classes II-IV, including unstable angina, myocardial infarction, serious cardiac arrhythmia, cerebral vascular accident, coronary/peripheral artery bypass graft surgery, transient ischaemic attack, or pulmonary embolism within 90 days prior to Screening.

What they're measuring

Stage 1: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through treatment related adverse events

Timeframe: From baseline to end of study treatment up to 30 days

Stage 2: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through physical examination abnormalities.

Timeframe: From Baseline, Day 1 (post dose), 4, 8, 15, 22, 29, 36, 43 or End of Study visit

Stage 1: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through vital signs- pulse rate

Timeframe: From baseline to end of study treatment up to 30 days

Stage 1: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through vital signs- blood pressure

Timeframe: From baseline to end of study treatment up to 30 days

Stage 1: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through vital signs- respiratory rate

Timeframe: From baseline to end of study treatment up to 30 days

Stage 1: Safety and tolerability of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through vital signs- oral aural temperature

Trial details

NCT IDNCT05216341

SponsorOliPass Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-07

View on ClinicalTrials.gov More Osteoarthritis trials

Who can participate

Age range35 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to provide written informed consent prior to any study-related procedures being performed in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) and local regulations.
✓. Male or female aged ≥ 35 years to ≤ 70 years as of the date of enrolment into the study
✓. No history of cardiac disease including arterial or venous thrombi, cardiac arrhythmia, myocardial infarction, admission to hospital for unstable angina, cardiac angioplasty or stent implantation within 90 days prior to Screening.
✓. Body mass index (BMI) ≥ 18 kg/m2 \< 40 kg/m2 at Screening.
✓. Pain in hip or knee joints, every day for at least 1-month during the 3 months prior to Screening.
✓. Diagnosis of Osteoarthritis (OA) of the index hip or knee: moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria with Kellgren Lawrence x-ray grade of at least 2, as diagnosed by the radiologist or rheumatologist.
✓. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain score of ≥ 10 out of 20 in the index hip or knee at Screening.
✓. Willing and able to provide their historical use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over-the-counter (OTC) per recommendation of a physician or prescribed during the past 6 months (the pain in the target knee and/or hip required).

Exclusion criteria

✕. Known history or current symptomatic heart failure as per New York Heart Association (NYHA) classes II-IV, including unstable angina, myocardial infarction, serious cardiac arrhythmia, cerebral vascular accident, coronary/peripheral artery bypass graft surgery, transient ischaemic attack, or pulmonary embolism within 90 days prior to Screening.