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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2023
  • participants needed
    27
  • sponsor
    Abcuro, Inc.
Updated on 5 March 2022
inclusion body myositis

Summary

An open-label, ascending dose study for adult patients with inclusion body myositis (IBM).

Details
Condition Inclusion Body Myositis
Treatment ABC008
Clinical Study IdentifierNCT04659031
SponsorAbcuro, Inc.
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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