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An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).
Participants who successfully complete the SAD EOT visit, and have no emerging safety issues, will be eligible to enroll in Part 2 (MAD). Eligible participants for the MAD part will have inclusion and exclusion criteria (same as those for Part 1) reviewed prior to dosing on MAD Day 1.
Participants who successfully complete the MAD EOT visit, and have no emerging safety issues, will be eligible to enrol in Part 3, MAD Extension.
After the final MAD visit (W48), participants will have the option to continue on to Part 3 MAD Extension.
For Part 3 (MAD Extension), participant dosing will be at 8-week intervals starting at Day 1. Duration of dosing in Part 3 will be up to approximately 80 weeks (18 months), or until a new long-term extension study has been initiated. The SMC will review all participant safety data approximately every 6 months while the Part 3 dosing continues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort D1 | Experimental | Single Dose 0.1 mg / kg ABC008 |
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| Cohort D2 | Experimental | Single Dose 0.5 mg / kg ABC008 |
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| Cohort D3 | Experimental | Single Dose 2.0 mg / kg ABC008 |
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| Cohort D4 | Experimental | Single Dose 5.0 mg / kg ABC008 |
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| Cohort D5 | Experimental | X.X mg / kg ABC008 |
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| Cohort 6 | Experimental | Single 2.0 mg / kg ABC008 |
|
| MAD Phase Cohort 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC008 | Drug | ABC008 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety and Tolerability | Characterize the safety and tolerability profile of single (SAD) and multiple (MAD) escalating dose levels of ABC008 in IBM when administered subcutaneously (SC) as measured by the number and severity of treatment emergent adverse events, serious adverse events, and adverse events of special interest, number of dose limiting toxicities. | Through Study Completion an average of 28 weeks for SAD (Single Ascending Dose) phase and 52 weeks for MAD (Multiple Ascending Dose) phase] |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of peak serum concentration (Cmax) | Assess the peak serum concentration (Cmax) of a single dose of ABC008 | Day 1 and throughout the 24 weeks of follow up |
| Assessment of time to peak serum concentration (Tmax) |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Royal Brisbane |
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| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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Multiple Dose 0.1 mg / kg ABC008 every 8 weeks |
|
| MAD Phase Cohort 2 | Experimental | Multiple Dose 0.5 mg / kg ABC008 every 8 weeks |
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| MAD Phase Cohort 3 | Experimental | Multiple Dose 2.0 mg / kg ABC008 every 8 weeks |
|
Assess the time to peak serum concentration (Tmax) of a single dose of ABC008
| Day 1 and throughout the 24 weeks of follow up |
| Assessment of terminal half-life (t½) | Assess the terminal half-life (t½) of ABC008 | Day 1 |
| Assessment of area under the concentration versus time curve from time zero to 24 hours post-dose (AUC0-24hr) | Assess the area under the concentration versus time curve of a single dose of ABC008 from time zero to 24 hours post-dose (AUC0-24hr) | Day 1 |
| Assessment of apparent clearance (CL/F) | Assessment of apparent clearance (CL/F) of a single dose of ABC008 | Day 1 and throughout the 24 weeks of follow up |
| Assessment of apparent volume of distribution (Vz/F) | Assessment of apparent volume of distribution (Vz/F) of a single dose of ABC008 | Day 1 and throughout the 24 weeks of follow up |
| Characterization of changes in KLRG1 expressing lymphocytes | Characterize changes in KLRG1 expressing lymphocytes | Day 1 and throughout the 24 weeks of follow up |
| Qualitative assessment of [ 89Zr]Zr-Df-crefmirlimab | Qualitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites as determined by using a visual scoring (VS) system for the time point assessed, the possible scores VS1-VS5 | [Through Study Completion, avg. 48 weeks |
| Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in skeletal muscle | Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in skeletal muscle; Pattern(s) of absolute and relative changes in uptake within various skeletal muscle groups; Homogenous/diffuse, Focal, Mixed, Other | [Through Study Completion, avg. 48 weeks |
| Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in lymphoid organs | Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in lymphoid organs; Uptake and relative changes in uptake within lymphoid tissue including spleen and lymph nodes as well as other T-cell rich tissues such as bone marrow | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab pre and post dosing of ABC008 | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake and relative changes in uptake within inflamed muscle tissue through Positron Emission Tomography (PET)/computed tomography (CT) imaging pre- and post-dosing with ABC008 | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis peak (SUVpeak) | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites, and measurement of magnitude of difference observations as determined by standardized uptake value (SUV)-based quantitative analysis peak (SUVpeak) | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis mean (SUVmean) | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites, and measurement of magnitude of difference observations as determined by standardized uptake value (SUV)-based quantitative analysis mean (SUVmean) | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis SUV of diseased muscle | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites, and measurement of magnitude of difference observations as determined by standardized uptake value (SUV)-based quantitative analysis SUV of diseased muscle | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis SUV reference tissue | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites, and measurement of magnitude of difference observations as determined by standardized uptake value (SUV)-based quantitative analysis SUV reference tissue | [Through Study Completion, avg. 48 weeks |
| Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis maximum (SUVmax) | Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab uptake in involved skeletal muscles including inflamed and non-inflamed sites, and measurement of magnitude of difference observations as determined by standardized uptake value (SUV)-based quantitative analysis maximum (SUVmax) | [Through Study Completion, avg. 48 weeks |
| Herston |
| Australia |
| Perron Institute | Perth | Australia |
| Royal North Shore Hospital | Sydney | Australia |
| D009422 |
| Nervous System Diseases |