A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Specified dose on specified days
Cullinan Investigative Site
Erlangen, Germany
RECRUITINGCullinan Investigative Site
Rome, Italy
RECRUITINGIncidence and severity of adverse events
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
Time frame: 48 wks
Serum concentrations of CLN-978
Serum concentrations of CLN-978
Time frame: 12 wks
Level of anti-drug antibodies
Level of anti-drug antibodies
Time frame: 12 wks
Pharmacodynamics-related biomarker
Levels of total B lymphocytes in the peripheral blood
Time frame: 48 wks
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