A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

Last updated: February 7, 2025
Sponsor: IGM Biosciences, Inc.
Overall Status: Terminated

Phase

1

Condition

Idiopathic Inflammatory Myopathies

Myositis

Treatment

Imvotamab

Clinical Study ID

NCT06524687
IGM-2323-103
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age ≥ 18 years at the time of signing ICF

  • Diagnosis of probable or definite IIM according to the 2017 European League AgainstRheumatism (EULAR)/American College of Rheumatology (ACR) classification criteriafor IIM with subgroup classification of either DM, polymyositis (PM),anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).

  • Active IIM despite treatment with corticosteroids and at least 1 immunosuppressiveor immunomodulatory standard-of-care agent determined at the discretion of theinvestigator after at least 3 months of treatment.

  • If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30mg/day of prednisone for at least 4 weeks prior to first study treatment

Exclusion

Key Exclusion Criteria:

  • Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.

  • Receipt of an investigational therapy less than 12 weeks or 5 drug-eliminationhalf-lives (whichever is longer) prior to first administration of study treatmentand during the study.

  • Has inclusion body myositis or myositis-associated with other connective tissuedisease.

Study Design

Total Participants: 2
Treatment Group(s): 1
Primary Treatment: Imvotamab
Phase: 1
Study Start date:
May 29, 2024
Estimated Completion Date:
January 21, 2025

Study Description

This is a Phase 1b, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.

Connect with a study center

  • Standford University

    Palo Alto, California 94306
    United States

    Site Not Available

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