A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: 50 mg LX3305 QD; Drug: 100 mg LX3305 QD; Drug: 150 mg LX3305 QD; Drug: 200 mg LX3305 QD; Drug: 250 mg LX3305 QD; Drug: 300 mg LX3305 QD; Drug: 400 mg LX3305 QD; Drug: 250 mg LX3305 BID; Drug: 500 mg LX3305 QD; Drug: Placebo

• Registration Number: NCT01417052
• Lead Sponsor: Lexicon Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-16
• Study Start: 2011-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50 mg LX3305 QD	50 mg LX3305 QD	-
100 mg LX3305 QD	100 mg LX3305 QD	-
150 mg LX3305 QD	150 mg LX3305 QD	-
200 mg LX3305 QD	200 mg LX3305 QD	-
250 mg LX3305 QD	250 mg LX3305 QD	-
300 mg LX3305 QD	300 mg LX3305 QD	-
400 mg LX3305 QD	400 mg LX3305 QD	-
250 mg LX3305 BID	250 mg LX3305 BID	-
500 mg LX3305 QD	500 mg LX3305 QD	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing an adverse event (AE)	14 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Dallas, Texas, United States