A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies (NCT06524687) | Clinical Trial Compass
TerminatedPhase 1
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
Stopped: Program Discontinuation
United States2 participantsStarted 2024-05-29
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.