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 range

35 Years – 70 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

35 Years – 70 Years

Sex

ALL

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).