The primary objective of this study is to determine the safety of LX3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
50 mg LX3305 once daily in capsule form
100 mg LX3305 once daily in capsule form
150 mg LX3305 once daily in capsule form
Lexicon Investigational Site
Dallas, Texas, United States
Number of subjects experiencing an adverse event (AE)
Time frame: 14 weeks
Change from baseline in absolute lymphocyte counts
Time frame: 14 weeks
Maximum observed plasma concentration
Time frame: 14 weeks
Time at which maximum observed plasma concentration occurs
Time frame: 14 weeks
Half-life of drug in plasma
Time frame: 14 weeks
Changes from baseline in global health
Time frame: 14 weeks
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200 mg LX3305 once daily in capsule form
250 mg LX3305 once daily in capsule form
300 mg LX3305 once daily in capsule form
400 mg LX3305 once daily in capsule form
250 mg LX3305 twice daily in capsule form
500 mg LX3305 once daily in capsule form
Matching placebo dosing in capsule form