Status and phase
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About
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies.
Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
Full description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 24 participants will be sequentially assigned to different dose escalation cohorts.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Age ≥ 18 years at the time of signing ICF
Documented diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 1 year prior to screening
Have had treatment with bDMARDs and/or tsDMARD and were refractory by 1 of 2 reasons:
Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)
Central lab results for hsCRP ≥ 0.8 mg/dL
Anti-citrullinated protein antibodies (ACPA) positive and/or rheumatoid factor (RF) positive
If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 10 mg/day of prednisone for at least 2 weeks prior to first study treatment
Key Exclusion Criteria:
History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA
Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
Receipt of any of the following excluded RA therapies:
Requiring therapy with prednisone > 10 mg/day (or equivalent dose) within 2 weeks prior to first study treatment
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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