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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis

All genders
person-wave 18-70
Recruiting now


Principal Investigator: Timothy McAlindon MD, MPH

This is a multi-center first-in-human, Phase 1, open-label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of single ascending doses of SBT777101 administered intravenously (IV) in subjects with active rheumatoid arthritis (RA) and an inadequate response to at least 2 prior biologic or targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) therapies with different mechanisms of action.

Study details

Inclusion Criteria
  • 1. Diagnosis of adult-onset rheumatoid arthritis with moderate-to-severe disease activity
  • 2. Must have at least 1 joint that can be used for synovial biopsy
  • 3. Have had an inadequate response to at least 2 prior treatment options with differing mechanisms of action.
Exclusion Criteria
  • 1. History of or current inflammatory joint disease other than rheumatoid arthritis or other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study.
  • 2. Females who are pregnant or breastfeeding or are planning to become pregnant within 12 months from start on study.
  • 3. History of malignancy within 5 years from the time of screening, except adequately treated basal cell carcinoma.
Study Requirements

- Approximately 18 visits to Tufts Medical Center with one overnight stay. - One apheresis - One infusion of the study drug - Give blood and urine at least 16 times each - Have one chest x-ray - Have 6 electrocardiograms (ECGs) - Have at least 2 synovial biopsies and 2 synovial fluid collections

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