Idiopathic Inflammatory Myopathies, Inflammatory Myopathies
Conditions
Keywords
Myopathies, Moderate-Severe Myopathy, Myositis
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 will be given imvotamab through a vein (i.e., intravenously).
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 Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.
Interventions
DRUGImvotamab
Administered intravenously
Sponsors
IGM Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 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-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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of imvotamab | Time Frame: Up to Week 50 | Incidence of adverse events (AEs), serious adverse events (SAEs), including serious |
Countries
United States
Outcome results
None listed