Phase
Condition
Idiopathic Inflammatory Myopathies
Myositis
Treatment
Imvotamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Standford University
Palo Alto, California 94306
United StatesSite Not Available
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