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

NCT05216341 | Completed Phase 2 DMC

• 1 other identifier: OLP-1002-002A
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (17)

• 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

  Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria, v5.0.

  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.

  Any abnormalities in the body System observed by the study physician in general appearance, Ears/Eyes/Nose/Throat/Thyroid, Head, Heart, Lungs, Abdomen, Skin, Neurological, Extremities, Back, Neck, Lymph Nodes, Dentition, Nusculoskeleton. For example, 1. Vital signs: out of range of normal BP systolic BP (lower than 90 and higher than 140), diastolic BP (lower than 40 and higher than 90), PR (50 -100), RR (10-20), BT(96-100 deg F) 2. abnormal clinical exam noted by physical examining investigator. 3. out of range of normal criteria of ECG parameters.

  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

  Measured by result of the vital signs- pulse rate

  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

  Measured by result of the Vital Sign- blood pressure (systolic and diastolic)

  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

  Measured by result of the vital signs- respiratory rate

  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

  Measured by result of the vital signs- oral aural temperature

  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 changes in BMI.

  Measured by body weight in kilograms (kg) and body height (centimetres) and body weight (kilograms). BMI will be calculated by dividing the participant's body weight in kilograms by the participant's height in meters squared (kg/m2).

  From screening visit, Day 1 and Day 30 or End of Study visit

• Stage 1: Safety of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through injection site reactions.

  The number of adverse events on injection site reaction per arms will be measured. Measured by severities or size of erythema, tenderness, bruise, and swelling will be recorded as the injection site reactions. Also, the number and rate of participants with any TEAEs will be recorded.

  Stage 1: From baseline to end of study treatment up to 30 days

• Stage 2: Safety of OLP-1002 (1μg and 2μg) compared to placebo in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through injection site reactions.

  The number of adverse events on injection site reaction per arms will be measured. Measured by severities or size of erythema, tenderness, bruise, and swelling will be recorded as the injection site reactions. Also, the number and rate of participants with any TEAEs will be recorded.

  Stage 2 : From Day 1 (post dose), 4, 8, 15, 22, 29, 39, and 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 clinical Biochemistry results

  Measured by clinically significant changes in Biochemistry results

  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 clinical Haematology results

  Measured by clinically significant changes in Haematology results

  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 clinical Urinalysis results

  Measured by clinically significant changes in Urinalysis results

  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 knee and/or hip joint through Electrocardiogram (ECG), start of atrial depolarization to start of ventricular depolarization (PR interval).

  Measured by PR interval in ECG

  From screening visit till the end of the study visit 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 Electrocardiogram (ECG) combination of the Q wave, R wave and S wave (QRS complex)

  Measured by QRS complex result in ECG

  From screening Visit till the end of the study visit 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 Electrocardiogram (ECG), time from the start of the Q wave to the end of the T wave (QT interval).

  Measured by QTcF result in ECG

  From screening visit till the end of the study visit up to 30 days

• Stage 2: Efficacy of single dose of OLP-1002 (1μg and 2μg) compared to placebo in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through changes in Western Ontario and McMaster Osteoarthritis Index (WOMAC)

  Measured by Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale

  From Screening visit, Day 1 (predose), Day 4, 8, 15, 22, 29, 39 and 43 or End of Study visit

• Stage 2: Efficacy of single dose of OLP-1002 (1μg and 2μg) compared to placebo in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through changes in Visual Analogue Scale (VAS) pain score.

  Measured by Visual Analogue Scale (VAS) pain score

  From Baseline, Day 1 (post dose), 4, 8, 15, 22, 29, 39 and 43 or End of Study visit

Secondary Outcomes (39)

• Stage 1: To evaluate the efficacy of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through Brief Pain Inventory questionnaire

  Monitored on Day 1, 4, 8, 15, 30

• Stage 1: To evaluate the efficacy of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through Patient Global Impression of Change questionnaire (PGIC)

  Monitored on Day 4, 15 and 30

• Stage 1: To evaluate the efficacy of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through Symptom and Quality of Life questionnaires of the KOOS.

  Monitored on Day 1, 8, 15, 30

• Stage 1: To evaluate the efficacy of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through Symptom and Quality of Life questionnaires of the HOOS.

  Monitored on Day 8, 15, 30

• Stage 1: To evaluate the efficacy of OLP-1002 in adults with moderate to severe pain due to osteoarthritis in a knee and/or hip joint through Western Ontario McMaster Osteoarthritis Index (WOMAC)

  From baseline to end of study treatment up to Day 1, Day 4, Day 8, Day 15, Day 30

Study Arms (9)

Stage 1: Arm 1 (OLP-1002, 1 μg)

EXPERIMENTAL

Participants will receive once single dose of 1 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 1: Arm 2 (OLP-1002, 3 μg)

EXPERIMENTAL

Participants will receive once single dose of 3 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 1: Arm 3 (OLP-1002, 10 μg)

EXPERIMENTAL

Participants will receive once single dose of 10 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 1: Arm 4 (OLP-1002, 25 μg)

EXPERIMENTAL

Participants will receive once single dose of 25 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 1: Arm 5 (OLP-1002, 50 μg)

EXPERIMENTAL

Participants will receive once single dose of 50 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 1: Arm 6 (OLP-1002, 80 μg)

EXPERIMENTAL

Participants will receive once single dose of 80 μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 2: Arm 1 (OLP-1002, 1μg)

EXPERIMENTAL

Participants will be randomised to receive single dose of 1μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 2: Arm 2 (OLP-1002, 2μg)

EXPERIMENTAL

Participants will be randomised to receive single dose of 2μg OLP-1002 on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Stage 2: Arm 3 (Placebo)

PLACEBO COMPARATOR

Participants will be randomised to receive single dose of Placebo on Day 1 Mode of Administration: subcutaneously injection

Drug: OLP-1002

Interventions

OLP-1002 DRUG

Stage 1: A total of 5 participants will be enrolled in each arm in Stage 1. Each participant will receive one single dose of OLP-1002 by subcutaneous injection. Stage 2: Up to 90 participants will be randomised on Day 1 to one of 3 treatment arms, in the ratio of 1:1:1 to receive one single dose of OLP-1002 (1 µg or 2 µg) or placebo. Each participant will receive one single dose of OLP-1002 or placebo by subcutaneous injection.

Also known as: Diluent (Placebo) - Only for Stage 2

Stage 1: Arm 1 (OLP-1002, 1 μg); Stage 1: Arm 2 (OLP-1002, 3 μg); Stage 1: Arm 3 (OLP-1002, 10 μg); Stage 1: Arm 4 (OLP-1002, 25 μg); Stage 1: Arm 5 (OLP-1002, 50 μg); Stage 1: Arm 6 (OLP-1002, 80 μg); Stage 2: Arm 1 (OLP-1002, 1μg); Stage 2: Arm 2 (OLP-1002, 2μg); Stage 2: Arm 3 (Placebo)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Note: Participants must have a pain severity score of ≥ 5 based on the 3-day mean VAS score during the Baseline Period and must have recorded the pain score every day during the Baseline Period.
• 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).
• Women of childbearing potential (WOCBP) 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 IP. Double contraception is defined as a condom AND one other form of the following:
• Established hormonal contraception (for example, approved oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones),
• A vaginal ring or an intrauterine device (IUD), or
• Documented evidence of surgical sterilisation at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is a sole partner).
• Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. A participant's treatment is acceptable.
• Women not of childbearing potential must be postmenopausal for ≥ 12 months. Post-menopausal status will be confirmed through testing of FSH levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Female participants who are abstinent from heterosexual intercourse will also be eligible.

You may not qualify if:

• 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.
• Participants with small pulmonary embolism not thought to put participants at higher risks of AEs may be allowed on a case-by-case basis in discussion with Sponsor.
• History of malignancy except for basal cell carcinoma with successful removal, ALL other non-melanoma skin cancers excised successfully more than 2 years ago, and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to the Screening Period.
• Any of the following:
• Intra-articular treatment injections (including but not limited to corticosteroids, hyaluronic acid, platelet rich plasma, BOTOX®, local anaesthetics) within 3 months prior to the Screening period,
• QTcF \> 450 ms confirmed by repeat ECG measurement,
• QRS duration \> 120 ms confirmed by repeat ECG measurement,
• PR interval \> 220 ms confirmed by repeat ECG measurement,
• Findings which would make QTc measurements difficult or QTcF data uninterpretable as per Investigator discretion,
• History of additional risk factors for torsades de pointes (eg, heart failure (class III/IV according to the New York Heart Association \[NYHA\]), hypo/hyperkalaemia, family history of long QT syndrome), or
• Taking any arrhythmic or arrythmia evoking agents.
• Unable or unwilling to cease the use of all pain reducing medications and all pain reducing devices, prescription or otherwise, as of the first day of the study Baseline Period and until the End of Study visit. These include all topical and oral opioid and antiinflammatory medications, herbal and homeopathic remedies, electrostimulation therapy (EST) and neuromuscular re-education (NMRE). This excludes the use of paracetamol provided that a participant is able and willing to utilise paracetamol/acetaminophen (2 g/day) as rescue medication or up to 4 g/day for intolerable pain following consent from the PI (or designee) without prior approval from the Sponsor, as of the first day of the study, Baseline Period, and until the End of Study visit.
• Note: The participant may continue taking usual medication for maintenance of health.
• Any of the following laboratory abnormalities within 14 days of Day 1:
• Platelet count \< 100,000 cells/mm3.

Sponsors & Collaborators

• OliPass Corporation: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (7)

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Novatrials

Kotara, New South Wales, 2289, Australia

Location

Sutherland Shire Clinical Research

Miranda, New South Wales, 2228, Australia

Location

Emeritus Research

Sydney, New South Wales, 2019, Australia

Location

AusTrials

Taringa, Queensland, 4068, Australia

Location

AusTrials

Wellers Hill, Queensland, 4121, Australia

Location

Emeritus Research

Melbourne, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Single Person

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Andrew Ostor

  Emeritus Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stage 1: open label Stage 2: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stage 1 - open label, dose-finding study, single ascending dose design Stage 2 - double-blind, placebo-controlled, parallel-arm study

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 31, 2022
• Study Start: January 11, 2021
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

AU (7)