Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000782932
Ethics application status
Approved
Date submitted
10/06/2020
Date registered
3/08/2020
Date last updated
3/08/2020
Date data sharing statement initially provided
3/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002.
Scientific title
A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain due to Moderate to Severe Osteoarthritis in a Hip and/or Knee joint
Secondary ID [1] 299655 0
OLP-1002-001B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 314991 0
Condition category
Condition code
Musculoskeletal 313323 313323 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study drug: OLP-1002
Proposed Dose:
1. 5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15)
2. 10 microgram BIW for 15 days (Day 1, 4, 8, 11 and 15)
Mode of Administration: Subcutaneous injection

The study will consist of 5 time periods:
• Screening period: up to14 days
• Washout period: 5 days (± 1 day)
• Baseline period: 3 days (± 1 day)
• Treatment period: 15 days (± 1 day)
• Follow-up period: 30 days from last dose (± 5 days)

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 BIW OLP-1002
• Arm B: 10 patients will receive 10 µg BIW OLP-1002
• Arm C: 10 patients will receive Placebo BIW
Intervention code [1] 315914 0
Treatment: Drugs
Comparator / control treatment
Placebo- Contains potassium phosphate, sodium phosphate, potassium chloride, sodium chloride, polysorbate 80, water for injection.
Control group
Placebo

Outcomes
Primary outcome [1] 321799 0
To evaluate the safety and tolerability of OLP-1002 in patients who have pain due to moderate to severe OA in a hip and/or knee joint.
Outcome is assessed by any adverse events, clinical laboratory, ECG abnormalities, physical examinations, vital signs and injection site assessments.
Timepoint [1] 321799 0
Monitored daily through Screening Visit till the end of the study visit(day 45).
Secondary outcome [1] 376243 0
To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods.
Measured by Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain, Stiffness and Physical Function Subscales together with Total WOMAC Score and Visual Analogue Scale (VAS).
Timepoint [1] 376243 0
Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.
Secondary outcome [2] 376244 0
To characterize the pharmacokinetic (PK) profile of OLP-1002.
Parameter: trough concentration (Ctrough)

sample type used for these analysis: serum sample
Timepoint [2] 376244 0
11PK samples will be collected pre-dose on days Day 1, 8 and 15 as well as on Day 45
Secondary outcome [3] 376245 0
To monitor the effects of multiple SC doses of OLP 1002 on Quality of Life (QoL).

Measured by Change from Baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS) and/or the Hip Injury and Osteoarthritis Outcome Score (HOOS) QoL Subscale
Timepoint [3] 376245 0
Monitored on Day 8, 15, 25, 32 and 45

Eligibility
Key inclusion criteria
1. 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;
2. 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;
3. Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;
4. Patients have pain in (a) hip or knee joint/s, every day for at least one month during the three months prior to Screening;
5. 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;
6. Patients with WOMAC Total Pain subscale score of equal to 10 in the index hip or knee at Screening;
7. Patients who are willing to discontinue all non-study pain medications except for permitted rescue pain medication for the duration of the study;
8. Patients agree to maintain their usual levels of activity throughout the course of the study and until End of Study (EOS) (Day 45);
9. 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);
10. Patients having clear injection sites, although parts of the body have tattoos;
11. Patients who are willing and able to comply with study procedures, including the recording of daily questionnaires;
12. 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:
a. Established hormonal contraception (for example, approved oral contraceptive pills (OCPs), long-acting implantable hormones, injectable hormones);
b. A vaginal ring or an intrauterine device (IUD); or
c. 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)
d. Women not of childbearing potential must be post menopausal for equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels equal to 40 IU/mL at Screening for amenorrhoeic female patients. Females who are abstinent from heterosexual intercourse will also be eligible.
e. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control. A patient’s complete abstinence for the duration of the study and for 90 days after the last study treatment is acceptable.
f. Female patients who are in a same-sex relationships are not required to use contraception.
g. Males must be surgically sterile (greater than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a women of child bearing potential (WOCBP), the patient and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until 90 days after the last dose of study drug. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Patients with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle;
13. 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;
14. Males must not donate sperm for at least 90 days after the last dose of study drug.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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)
2. 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
3. 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;
4. Use or intend to use TENS machine during the study period, i.e. from screening until after Day 45 of the study;
5. Any of the following laboratory abnormalities within14 days of the first treatment day:
• Platelet count less than 100,000 cells/mm3
• Total neutrophil count less than 1500 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
• Alkaline phosphatase greater than 2.0 x ULN
• Bilirubin greater than 1.5 x ULN
• Temperature greater than or equal to 38°C or any other evidence of an infection
6. History of alcohol or substance abuse or dependence during the 12 months prior to Screening
• During the study, alcohol consumption of greater than 21 units per week for males and greater than14 units per week for females will not be allowed. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits;
• Positive urine drug screen (confirmed by repeat) or alcohol consumption (self-report) higher than the permissible limit, as mentioned above, within the preceding 3 days at Screening or Baseline shall be excluded from the study;
7. Use or intend to use medication that interacts with CYP3A4 and/or CYP2D6, see Section 9.4.1 on restricted medication ;
8. Has an allergy or hypersensitivity to the study drug or its components;
9. Female patients who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding;
10. Patients with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments;
11. Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal skin healing in any body area;
12. 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;
13. Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9 greater than or equal to 10) at the Screening visit;
14. History of psychotic symptoms requiring antipsychotic treatment, or history of a suicide attempt/s within 180 days prior to Screening;
15. 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;
16. 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;
17. Current medical or arthritic condition/s that could interfere with evaluation of the index joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies;
18. Patient who has undergone arthroscopic or open surgery to the index joint/s within 180 days of Screening visit;
19. Patient who has undergone replacement surgery of the index joint/s within 180 days of Screening visit;
20. The placement of surgical hardware or other foreign body in the treatment joint/s within 180 days of Screening visit;
21. 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);
22. 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;
23. 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);
24. 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;
25. 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;
26. Receipt of blood products within 60 days prior to Screening visit;
27. Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening;
28. Poor peripheral venous access;
29. Are sponsor employees;
30. 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;
31. 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;
32. Have previously completed or withdrawn from this study or any other study investigating OLP-1002 or have previously received the study drug;
33. Patients who, in the opinion of the Investigator (or designee), should not participate in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/06/2020
Date of last participant enrolment
Anticipated
15/08/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
30
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16848 0
Emeritus Research - Camberwell
Recruitment hospital [2] 16850 0
Paratus Clinical Pty Ltd Blacktown Trial Clinic - Blacktown
Recruitment hospital [3] 16851 0
Novatrials - Kotara
Recruitment postcode(s) [1] 30493 0
3124 - Camberwell
Recruitment postcode(s) [2] 30495 0
2148 - Blacktown
Recruitment postcode(s) [3] 30496 0
2289 - Kotara

Funding & Sponsors
Funding source category [1] 304127 0
Commercial sector/Industry
Name [1] 304127 0
OliPass Corporation
Country [1] 304127 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
OliPass Corporation
Address
Ace Dongbaek Tower 20th Floor
16 Beon-gil, 16-4 Dongbaek Jungang-ro
Giheung, Yongin, Gyeonggi 17015
Republic of Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 304347 0
None
Name [1] 304347 0
Address [1] 304347 0
Country [1] 304347 0
Other collaborator category [1] 281015 0
Commercial sector/Industry
Name [1] 281015 0
Novotech (Australia) Pty Limited
Address [1] 281015 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 281015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304613 0
Bellberry HREC
Ethics committee address [1] 304613 0
Ethics committee country [1] 304613 0
Australia
Date submitted for ethics approval [1] 304613 0
27/03/2020
Approval date [1] 304613 0
22/05/2020
Ethics approval number [1] 304613 0
2020-02-164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97586 0
A/Prof Andrew Ostor
Address 97586 0
Emeritus Research
Address: Level 2, 1180 Toorak Road, Camberwell ,Victoria 3124, Australia
Country 97586 0
Australia
Phone 97586 0
+61 03 9509 6166
Fax 97586 0
Email 97586 0
[email protected]
Contact person for public queries
Name 97587 0
Toula Papadodimitrakis
Address 97587 0
Novotech (Australia) Pty Limited
Address: Level 2, 15-31 Pelham Street, Carlton VIC 3053 , Australia
Country 97587 0
Australia
Phone 97587 0
+61 03 9491 8505
Fax 97587 0
Email 97587 0
[email protected]
Contact person for scientific queries
Name 97588 0
Toula Papadodimitrakis
Address 97588 0
Novotech (Australia) Pty Limited

Address: Level 2, 15-31 Pelham Street, Carlton VIC 3053 , Australia
Country 97588 0
Australia
Phone 97588 0
+61 03 9491 8505
Fax 97588 0
Email 97588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.