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A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)

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ClinicalTrials.gov Identifier: NCT04659031
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Abcuro, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 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 : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Cohort D1
X.X mg / kg ABC008
Drug: ABC008
ABC008

Experimental: Cohort D2
X.X mg / kg ABC008
Drug: ABC008
ABC008

Experimental: Cohort D3
X.X mg / kg ABC008
Drug: ABC008
ABC008

Experimental: Cohort D4
X.X mg / kg ABC008
Drug: ABC008
ABC008

Experimental: Cohort D5
tbd (if an alternative dose cohort is needed)
Drug: ABC008
ABC008




Primary Outcome Measures :
  1. 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.


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



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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

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: Angela Skipper 617-766-5908 ASkipper@hallorancg.com

Locations
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Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Helen Birkin         
Principal Investigator: Roula Ghaoui, M.D.         
Australia
Perron Institute Recruiting
Perth, Australia
Contact: Sue Walters         
Principal Investigator: Merilee Needham         
Sponsors and Collaborators
Abcuro, Inc.
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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: September 29, 2021
Last Verified: September 2021
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