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
University Hospital Erlangen
Erlangen, Germany
RECRUITINGUniversity Hospital Heidelberg
Heidelberg, Germany
RECRUITINGFondazione Policlinico Universitario A Gemelli
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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