A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
Phase 1
Terminated
- Conditions
- Idiopathic Inflammatory MyopathiesInflammatory Myopathies
- Interventions
- Registration Number
- NCT06524687
- Lead Sponsor
- IGM Biosciences, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imvotamab (Dose Escalation) Imvotamab Imvotamab administered intravenously
- Primary Outcome Measures
Name Time Method Safety and tolerability of imvotamab Time Frame: Up to Week 50 Incidence of adverse events (AEs), serious adverse events (SAEs), including serious
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Standford University
🇺🇸Palo Alto, California, United States