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This goal of this open label study is to evaluate the safety and tolerability of a single intra-articular administration of ABR1 in adults with knee osteoarthritis with a KL grade from 2 to 4. The primary questions it aims to answer are:
Participants will receive a single injection of ABR1 to the knee with osteoarthritis. Participants will
This first-in-human study is a single-site, open-label, single-arm investigation in adults with knee osteoarthritis from KL grade 2 to 4 evaluating safety and tolerability of a single, ultrasound-guided intra-articular injection of ABR1, while also observing any signals of symptom improvement over 24 weeks post-injection. All enrolled participants will receive a single administration of ABR1 intraarticularly in the target knee and will be followed per protocol for safety monitoring and clinical assessments. Participants should continue to take their medications for pre-existing medical conditions as usual during the trial. Participants will be advised that they may use study allowed rescue medication to treat worsening pain. Participants will record any rescue medication use in their Participant Diary.
Researchers will assess the incidence of adverse events, its relatedness to the device, and the incidence of any treatment-related serious adverse events through Week 12. Patient reported outcomes related to knee osteoarthritis pain will be observed up to Week 24 post injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received ABR1 | Experimental | Received a single dose of ABR1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABR1 | Device | Received a single dose of ABR1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Incidence of treatment-emergent adverse events (TEAEs) through Week 12 | from the day receiving study intervention (day 0) to 12 weeks after study intervention |
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Inclusion Criteria:
Male or female at least 40years of age
Knee OA with Kellgren-Lawrence (KL) Grade 2 to 4 of the target knee on X-ray
Inadequate pain relief with 1st line treatment, consisting of any of the following
Target knee pain on most days (at least 15 days per month in the preceding month)
Symptomatic knee OA with moderate to severe pain (NRS ≥4 and <9 on Numeric Rating Scale (NRS) with target knee significantly worse than the other knee with a minimum difference of 2-point between knees.
Possess cognitive and language ability to complete informed consent and questionnaires
Willingness to follow protocol instructions and maintain appointment schedule of the study
Willingness to maintain their existing stable regimen (defined as the same regimen for at least the past 30 days) of complementary and non-pharmacological knee OA treatments for trial duration (if any)
If participant is taking a stable regimen of NSAIDs - they are willing to maintain their existing stable regimen (defined as taking the same dose for at least the past 30 days) of NSAIDs and not anticipate to change for the duration of the study.
Willingness to stop any 'as needed' (PRN) NSAIDs or paracetamol or opioids (except for protocol-permitted rescue pain medication) for the duration of the trial
Willingness to stop taking any rescue pain meds 24 hours prior to scheduled follow up clinic visits (except for their stable NSAIDs therapy)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 0295625360 | lotus.study@sydney.edu.au | |
| Camilla Herberstein | Contact | 0295625360 | camilla.herberstein@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Charis Lau, PharmD, OD, MBA | Pleryon Therapeutics Limited | Study Chair |
| David Hunter, MD | Royal North Shore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31164421 | Background | Sun Z, Feeney E, Guan Y, Cook SG, Gourdon D, Bonassar LJ, Putnam D. Boundary mode lubrication of articular cartilage with a biomimetic diblock copolymer. Proc Natl Acad Sci U S A. 2019 Jun 18;116(25):12437-12441. doi: 10.1073/pnas.1900716116. Epub 2019 Jun 4. |
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Study model is a sterile, transparent solution provided in a pre-filled syringe for intra-articular injection
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