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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 : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Abcuro, Inc.

Tracking Information
First Submitted Date  ICMJE November 25, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date January 4, 2023
Actual Study Start Date  ICMJE May 25, 2021
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2023)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)		 Assessment of Safety and Tolerability [ Time Frame: Through Study Completion an average of 28 weeks ]
Characterize the safety and tolerability profile of 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2023)
  • 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
  • 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
  • Assessment of terminal half-life (t½) [ Time Frame: Day 1 ]
    Assess the terminal half-life (t½) of ABC008
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • 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
  • 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
  • Assessment of terminal half-life (t½) [ Time Frame: Day 1 ]
    Assess the terminal half-life (t½) of ABC008
  • 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)
  • 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
  • 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
  • Evaluation of the immune response by characterization of changes in KLRG1 expressing lymphocytes [ Time Frame: Day 1 and throughout the 24 weeks of follow up ]
    Evaluate the immune response by characterizing changes in KLRG1 expressing lymphocytes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)
Official Title  ICMJE A Phase 1, Open-Label, Ascending Dose Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)
Brief Summary An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inclusion Body Myositis
Intervention  ICMJE Drug: ABC008
ABC008
Study Arms  ICMJE
  • Experimental: Cohort D1
    Single Dose 0.1 mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: Cohort D2
    Single Dose 0.5 mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: Cohort D3
    Single Dose 2.0 mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: Cohort D4
    Single Dose 5.0 mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: Cohort D5
    X.X mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: Cohort 6
    Single 2.0 mg / kg ABC008
    Intervention: Drug: ABC008
  • Experimental: MAD Phase Cohort 1
    Multiple Dose 0.1 mg / kg ABC008 every 8 weeks
    Intervention: Drug: ABC008
  • Experimental: MAD Phase Cohort 2
    Multiple Dose 0.5 mg / kg ABC008 every 8 weeks
    Intervention: Drug: ABC008
  • Experimental: MAD Phase Cohort 3
    Multiple Dose 2.0 mg / kg ABC008 every 8 weeks
    Intervention: Drug: ABC008
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2023)		 30
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2020)		 39
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ken Cooper 610-310-2271 Ken.cooper@abcuro.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04659031
Other Study ID Numbers  ICMJE ABC008-IBM-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Abcuro, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abcuro, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abcuro, Inc.
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP