Status:
TERMINATED
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
Lead Sponsor:
IGM Biosciences, Inc.
Conditions:
Idiopathic Inflammatory Myopathies
Inflammatory Myopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wi...
Detailed 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...
Eligibility Criteria
Inclusion
- Key
- Age ≥ 18 years at the time of signing ICF
- Diagnosis of probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for 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 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
- If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment
- Key
Exclusion
- 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-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.
- Has inclusion body myositis or myositis-associated with other connective tissue disease.
Key Trial Info
Start Date :
May 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06524687
Start Date
May 29 2024
End Date
January 21 2025
Last Update
February 11 2025
Active Locations (1)
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1
Standford University
Palo Alto, California, United States, 94306