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Clinical Trials/NCT01417052
NCT01417052CompletedPhase 1

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)

Lexicon Pharmaceuticals1 site in 1 country10 target enrollmentStarted: September 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Number of subjects experiencing an adverse event (AE)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

50 mg LX3305 QD

Experimental

Intervention: 50 mg LX3305 QD (Drug)

100 mg LX3305 QD

Experimental

Intervention: 100 mg LX3305 QD (Drug)

150 mg LX3305 QD

Experimental

Intervention: 150 mg LX3305 QD (Drug)

200 mg LX3305 QD

Experimental

Intervention: 200 mg LX3305 QD (Drug)

250 mg LX3305 QD

Experimental

Intervention: 250 mg LX3305 QD (Drug)

300 mg LX3305 QD

Experimental

Intervention: 300 mg LX3305 QD (Drug)

500 mg LX3305 QD

Experimental

Intervention: 500 mg LX3305 QD (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

250 mg LX3305 BID

Experimental

Intervention: 250 mg LX3305 BID (Drug)

400 mg LX3305 QD

Experimental

Intervention: 400 mg LX3305 QD (Drug)

Outcomes

Primary Outcomes

Number of subjects experiencing an adverse event (AE)

Time Frame: 14 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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