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Trial record 2 of 3 for:    ABC008
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A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)

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ClinicalTrials.gov Identifier: NCT04659031
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Abcuro, Inc.

Study Description
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Brief Summary:
An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).

Condition or disease Intervention/treatment Phase
Inclusion Body Myositis Drug: ABC008 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Ascending Dose Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)
Actual Study Start Date : May 25, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Myositis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort D1
Single Dose 0.1 mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: Cohort D2
Single Dose 0.5 mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: Cohort D3
Single Dose 2.0 mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: Cohort D4
Single Dose 5.0 mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: Cohort D5
X.X mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: Cohort 6
Single 2.0 mg / kg ABC008
 Drug: ABC008
ABC008
Experimental: MAD Phase Cohort 1
Multiple Dose 0.1 mg / kg ABC008 every 8 weeks
 Drug: ABC008
ABC008
Experimental: MAD Phase Cohort 2
Multiple Dose 0.5 mg / kg ABC008 every 8 weeks
 Drug: ABC008
ABC008
Experimental: MAD Phase Cohort 3
Multiple Dose 2.0 mg / kg ABC008 every 8 weeks
 Drug: ABC008
ABC008


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Safety and Tolerability [ Time Frame: Through Study Completion an average of 28 weeks for SAD (Single Ascending Dose) phase and 52 weeks for MAD (Multiple Ascending Dose) phase] ]
    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.


Secondary Outcome Measures :
  1. Assessment of peak serum concentration (Cmax) [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Assess the peak serum concentration (Cmax) of a single dose of ABC008

  2. Assessment of time to peak serum concentration (Tmax) [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Assess the time to peak serum concentration (Tmax) of a single dose of ABC008

  3. Assessment of terminal half-life (t½) [ Time Frame: Day 1 ]
    Assess the terminal half-life (t½) of ABC008

  4. Assessment of area under the concentration versus time curve from time zero to 24 hours post-dose (AUC0-24hr) [ Time Frame: Day 1 ]
    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)

  5. Assessment of apparent clearance (CL/F) [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Assessment of apparent clearance (CL/F) of a single dose of ABC008

  6. Assessment of apparent volume of distribution (Vz/F) [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Assessment of apparent volume of distribution (Vz/F) of a single dose of ABC008

  7. Characterization of changes in KLRG1 expressing lymphocytes [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Characterize changes in KLRG1 expressing lymphocytes

  8. Qualitative assessment of [ 89Zr]Zr-Df-crefmirlimab [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  9. Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in skeletal muscle [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  10. Assessment of global distribution of [ 89Zr]Zr-Df-crefmirlimab uptake in lymphoid organs [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  11. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab pre and post dosing of ABC008 [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  12. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis peak (SUVpeak) [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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)

  13. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis mean (SUVmean) [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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)

  14. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis SUV of diseased muscle [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  15. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis SUV reference tissue [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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

  16. Quantitative assessment of [ 89Zr]Zr-Df-crefmirlimab, determined by standardized uptake value (SUV)-based quantitative analysis maximum (SUVmax) [ Time Frame: [Through Study Completion, avg. 48 weeks ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Center (ENMC) IBM 2011
  • Able to arise from a chair (with or without armrests) without support from another person or device
  • Able to ambulate at least 20 feet / 6 meters with or without assistive device

Exclusion Criteria:

  • Taking > 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (IVIg) or other immunosuppressants within the last 3 months. Topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the Investigator's opinion. Local steroid injections are allowed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659031


Contacts
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Contact: Ken Cooper 610-310-2271 Ken.cooper@abcuro.com

Locations
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Australia, South Australia
Royal Adelaide Hospital Completed
Adelaide, South Australia, Australia, 5000
Australia
Royal Brisbane Recruiting
Herston, Australia
Contact: Susan Heggie         
Contact: Kathryn Thorpe         
Principal Investigator: Robert Henderson, MD         
Perron Institute Recruiting
Perth, Australia
Contact: Sue Walters         
Principal Investigator: Merilee Needham         
Royal North Shore Hospital Active, not recruiting
Sydney, Australia
Sponsors and Collaborators
Abcuro, Inc.
More Information
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Responsible Party: Abcuro, Inc.
ClinicalTrials.gov Identifier: NCT04659031    
Other Study ID Numbers: ABC008-IBM-101
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abcuro, Inc.:
Inclusion Body Myositis
IBM
Additional relevant MeSH terms:
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Myositis
Myositis, Inclusion Body
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases