A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients with (IBM)

Last updated: February 18, 2025
Sponsor: Abcuro, Inc.
Overall Status: Completed

Phase

1

Condition

Myositis

Polymyositis (Inflammatory Muscle Disease)

Idiopathic Inflammatory Myopathies

Treatment

ABC008

Clinical Study ID

NCT04659031
ABC008-IBM-101
  • Ages > 40
  • All Genders

Study Summary

An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, orprobable IBM according to the European Neuromuscular Center (ENMC) IBM 2011

  • Able to arise from a chair (with or without armrests) without support from anotherperson or device

  • Able to ambulate at least 20 feet / 6 meters with or without assistive device

Exclusion

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 ocularcorticosteroids are allowed unless they are being widely applied or the severity ofthe underlying condition makes them unsuitable in the Investigator's opinion. Localsteroid injections are allowed

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: ABC008
Phase: 1
Study Start date:
May 25, 2021
Estimated Completion Date:
January 10, 2025

Study Description

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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Brisbane

    Herston,
    Australia

    Site Not Available

  • Perron Institute

    Perth,
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Sydney,
    Australia

    Site Not Available

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