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About
This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of:
Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:
Full description
Study drug: OLP-1002
Proposed Dose:
Mode of Administration: Subcutaneous injection
The study will consist of 5 time periods:
Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female aged greater than or equal to 35 years to lesser than or equal to 65 years as of the date of study enrolment;
Patients must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;
Patients have pain in (a) hip or knee joint/s, every day for at least one month during the three months prior to Screening;
Patients have a diagnosis of moderate to severe 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 3 as diagnosed by the radiologist;
Patients with WOMAC Total Pain subscale score of ≥ 10 in the index hip or knee at Screening;
Patients who are willing to discontinue all non-study pain medications except for permitted rescue pain medication for the duration of the study;
Patients agree to maintain their usual levels of activity throughout the course of the study and until End of Study (EOS) (Day 45);
Patients who are willing to abstain from all other intra-articular treatments of the joint and any joint surgery while in the study and until EOS (Day 45);
Patients having clear injection sites, although parts of the body have tattoos;
Patients who are willing and able to comply with study procedures, including the recording of daily questionnaires;
Females must be non-pregnant and non-lactating, and must use acceptable, highly effective double contraception from screening until 90 days after the last dose of study drug. Double contraception is defined as a condom AND one other form of the following:
WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study;
Males must not donate sperm for at least 90 days after the last dose of study drug.
Exclusion criteria
Any of the following:
Intraarticular treatment injections (including but not limited to corticosteroids, hyaluronic acid, platelet rich plasma, BOTOX®, local anaesthetics) within 3 months prior to the Screening period
Patients who are unable or unwilling to cease the use of all pain medications, prescription, over-the-counter and otherwise, as of the first day of the study Washout Period and until after Day 45 of the study. This includes all opioid and anti-inflammatory medications. This excludes the use of paracetamol provided that a patient is able and willing to utilise a maximum of 2 g of paracetamol per 24-hour period as of the first day of the study Washout Period and until after Day 45 of the study, unless the PI has approved an increased dose up to 4 g;
Use or intend to use TENS machine during the study period, i.e. from screening until after Day 45 of the study;
Any of the following laboratory abnormalities within 14 days of the first treatment day:
History of alcohol or substance abuse or dependence during the 12 months prior to Screening
Use or intend to use medication that interacts with CYP3A4 and/or CYP2D6.
Has an allergy or hypersensitivity to the study drug or its components;
Female patients who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding;
Patients with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments;
Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal skin healing in any body area;
Patients who have tattoos, scars, or moles that in the opinion of the Investigator are likely to interfere with dosing or study assessments at any of the potential injection sites;
Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9 greater than or equal to 10) at the Screening visit;
History of psychotic symptoms requiring antipsychotic treatment, or history of a suicide attempt/s within 180 days prior to Screening;
Arterial or venous thrombus, myocardial infarction, hospital admission for unstable angina, treatment with cardiac angioplasty, or cardiac vessel stenting within 90 days prior to Screening;
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
Current medical or arthritic condition/s that could interfere with evaluation of the index joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies;
Patient who has undergone arthroscopic or open surgery to the index joint/s within 180 days of Screening visit;
Patient who has undergone replacement surgery of the index joint/s within 180 days of Screening visit;
The placement of surgical hardware or other foreign body in the treatment joint/s within 180 days of Screening visit;
Use or intend to use any medications/products known to alter the absorption, metabolism, or elimination processes of the study drug, including but not limited to St. John's Wort, within 30 days prior to Screening visit, unless deemed acceptable by the Investigator (or designee);
Use or intend to use any prescription medications/products within 14 days prior to Screening, unless deemed acceptable by the Investigator (or designee). Note: hormone replacement therapy or oral, implantable, injectable, or intrauterine contraceptive concomitant medications are acceptable;
Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Screening, unless deemed acceptable by the Investigator (or designee);
Use or intend to use any non-prescription medications/products including phytotherapeutic/herbal/plant-derived preparations within 14 days prior to Screening visit, unless deemed acceptable by the Investigator (or designee) and Sponsor, or assignee, has given their prior consent;
Patients who are unable or unwilling to cease the use of tobacco- or nicotine-containing products during the study duration and have used tobacco- or nicotine-containing products within 90 days prior to Screening visit;
Receipt of blood products within 60 days prior to Screening visit;
Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening;
Poor peripheral venous access;
Are sponsor employees;
Have participated in a clinical study involving administration of an investigational drug in the past 90 days or 5 half-lives of the study drug, whichever is longer, prior to Screening visit;
Have participated in any trial of a device, supplement, cognitive/behavioural therapy, physiotherapy or active exercise study within 30 days prior to the Screening visit;
Have previously completed or withdrawn from this study or any other study investigating OLP-1002 or have previously received the study drug;
Patients who, in the opinion of the Investigator (or designee), should not participate in this study.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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