A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies

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Description

Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Treatment Period (4 weeks): This study will use a drug called Imvotamab. If you are eligible to enter the study, you will enter the Study Treatment period and will be randomly assigned to receive either the study drug (Imvotamab) or placebo.. The study drug or placebo will be given once a week for four weeks and given through a vein (also called intravenous [IV] administration). Safety Follow Up Period (48 weeks): There will be six follow up visits at approximately 5, 6, 12, 24, 36, and 52 weeks after your first dose of study drug or placebo. You will be asked to return to the clinic for these visits to perform safety assessments. The study team will determine how you are doing, and you will be asked if you have started any new therapies. These visits will continue until the end of the study, or until you withdraw consent.

Details
Age

Adult

Eligibility

To be eligible for this study a participant must meet all the following criteria: - Age 18 years or older - Diagnosis of moderate to severe rheumatoid arthritis (RA) that is not well managed by current medications - Have tried and failed to respond to medications for the treatment of RA - Have swollen and/or tender joints - Up-to-date on COVID-19 vaccinations according to the CDC's recommendations for immunocompromised individuals- Have tried and failed to respond to at least 2 biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for the treatment of RA, which includes but is not limited to Humira, Enbrel, Simponi, Remicade, Actemra, Kevzara, Orencia, Rituxan, Xeljanz, and Rinvoq

Locations

Barbara Davis Center
Cherry Creek Medical Center
CTRC Inpatient
University of Colorado Hospital

Principal Investigator
Photograph of Larry Moreland

Larry Moreland

Study ID

Protocol Number: 23-1290

More information available at ClinicalTrials.gov: NCT06087406

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