Rheumatoid Arthritis
Conditions
Brief summary
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).
Interventions
DRUG50 mg LX3305 QD
50 mg LX3305 once daily in capsule form
DRUG100 mg LX3305 QD
100 mg LX3305 once daily in capsule form
DRUG150 mg LX3305 QD
150 mg LX3305 once daily in capsule form
DRUG200 mg LX3305 QD
200 mg LX3305 once daily in capsule form
DRUG250 mg LX3305 QD
250 mg LX3305 once daily in capsule form
DRUG300 mg LX3305 QD
300 mg LX3305 once daily in capsule form
DRUG400 mg LX3305 QD
400 mg LX3305 once daily in capsule form
DRUG250 mg LX3305 BID
250 mg LX3305 twice daily in capsule form
DRUG500 mg LX3305 QD
500 mg LX3305 once daily in capsule form
DRUGPlacebo
Matching placebo dosing in capsule form
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult subjects, aged 18 to 75 years * Active rheumatoid arthritis (RA), class I to III (defined by the American College of Rheumatology), diagnosed at least 3 months prior to Screening * Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (at Screening and Day 1), and serum C-reactive protein (CRP) level \>1.2x the upper limit of normal and/or elevated erythrocyte sedimentation rate (ESR) * If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated for at least 6 weeks prior to Screening and currently receiving a stable dose of methotrexate (MTX) with a stable route of administration, and have no plans to change MTX dose during the study * Ability to give written informed consent
Exclusion criteria
* Women who are pregnant or nursing * RA diagnosis prior to 16 years of age (juvenile RA) * Intra-articular and/or parenteral corticosteroids within 4 weeks of study Day 1 * Receipt of live vaccine within 4 weeks prior to Day 1 * Major surgical procedure within 8 weeks prior to Day 1 * Blood donation within 4 weeks prior to Day 1 * Any systemic inflammatory condition * History of bleeding diathesis * History of medically significant opportunistic infection * History of drug or alcohol abuse within 3 years prior to Day 1 * History of cancer within 5 years prior to Day 1 * Presence of hepatic or biliary disease * History of tuberculosis * History of human immunodeficiency virus (HIV) * Any clinically significant laboratory test results, in the opinion of the investigator * Use of any investigational agent or participation in an investigative trial within 30 days of Day 1 * Concurrent use of any biologic agent for the treatment of RA or concomitant disease modifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, and sulfasalazine - at stables doses for 8 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing an adverse event (AE) | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in absolute lymphocyte counts | 14 weeks |
| Maximum observed plasma concentration | 14 weeks |
| Time at which maximum observed plasma concentration occurs | 14 weeks |
| Half-life of drug in plasma | 14 weeks |
| Changes from baseline in global health | 14 weeks |
Countries
United States
Outcome results
None listed