A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002

NCT04677933 | Completed Phase 1 DMC

• 1 other identifier: OLP-1002-001B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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:

• Screening period: up to 14 days (defined as Day -23 to -9)
• Washout period: 5 days (± 1 day) (defined as Day -8 to -4)
• Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing)
• Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing)
• Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:
• Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002
• Arm B: 10 patients will receive 10 µg BIW OLP-1002
• Arm C: 10 patients will receive Placebo BIW

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (7)

• Incidence of Treatment- Emergent Adverse Events(Safety and Tolerability) of OLP-1002 in patients who have pain in a hip and/or knee joint

  Number of participants with treatment-related adverse events as assessed by CTCAE

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- heart rate

  Measured by result of the Vital Sign- heart rate

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure

  Measured by result of the Vital Sign- blood pressure

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- oral temperature

  Measured by result of the Vital Sign- oral temperature

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG

  Measured by result of the ECG measurements and findings Parameters: QRS, ST segment, and QTcF.

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam

  Measured by result of the physical exam which includes general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.

  Monitored from Screening Visit till the end of the study visit(day 45).

• Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results

  Measured by clinically significant change from baseline clinical laboratory results

  Monitored from Screening Visit till the end of the study visit(day 45).

Secondary Outcomes (5)

• To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through WOMAC. The minimum and maximum values, and whether higher scores mean a better or worse outcome.

  Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.

• To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through VAS. The minimum and maximum values, and whether higher scores mean a better or worse outcome.

  Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.

• To characterize the pharmacokinetic (PK) profile of OLP-1002 trough concentration (Ctrough)

  PK samples will be collected pre-dose on days Day 1, 8 and 15 as well as on Day 45

• To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (KOOS). The minimum and maximum values, and whether higher scores mean a better or worse outcome.

  Monitored on Day 8, 15, 25, 32 and 45

• To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (HOOS) QoL Subscale. The minimum and maximum values, and whether higher scores mean a better or worse outcome.

  Monitored on Day 8, 15, 25, 32 and 45

Study Arms (3)

Arm A

EXPERIMENTAL

Patients will receive 5 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection

Drug: A: OLP-1002

Arm B

EXPERIMENTAL

Patients will receive 10 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection

Drug: B: OLP-1002

Arm C

EXPERIMENTAL

Patients will receive Diluent placebo BIW for 15 days (Day 1, 4, 8, 11 and 15) Mode of Administration: Subcutaneous injection

Drug: C: Placebo

Interventions

A: OLP-1002 DRUG

10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002

Also known as: OLP-1002: A

Arm A

B: OLP-1002 DRUG

10 patients will receive 10 µg OLP-1002 BIW OLP-1002

Also known as: OLP-1002: B

Arm B

C: Placebo DRUG

10 patients will receive Placebo BIW

Also known as: Placebo

Arm C

Eligibility Criteria

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

You may qualify if:

• 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:
• 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 (e.g., 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)

You may not qualify if:

• Any of the following:
• QTcF greater than 450 ms confirmed by repeat ECG measurement
• QRS duration greater than 110 ms confirmed by repeat ECG measurement
• PR interval greater than 220 ms confirmed by repeat ECG measurement
• Findings which would make QTc measurements difficult or QTcF data uninterpretable
• History of additional risk factors for torsades de pointes (e.g., heart failure (class III/IV according to the New York Heart Association \[NYHA\]), hypokalaemia, family history of long QT syndrome)
• 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:
• Platelet count less than 100,000 cells/mm3
• Total neutrophil count less than 1,500 cells/mm3
• Serum creatinine greater than or equal to 1.5 x ULN
• Alanine aminotransferase (ALT) greater than 3.0 x ULN
• Aspartate aminotransferase (AST) greater than 3.0 x ULN

Sponsors & Collaborators

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

Study Sites (4)

Paratus Clinical Research- Canberra Trial Clinic

Canberra, Australian Capital Territory, 2617, Australia

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Novatrials (Pendlebury Research)

Newcastle, New South Wales, 2289, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrew Ostor

  Emeritus Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 21, 2020
• Study Start: June 3, 2020
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

AU (4)