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Completed

NCT Number: NCT01417052

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Dallas, Texas, 75231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

50 mg LX3305 QD

Drug

50 mg LX3305 once daily in capsule form

100 mg LX3305 QD

Drug

100 mg LX3305 once daily in capsule form

150 mg LX3305 QD

Drug

150 mg LX3305 once daily in capsule form

200 mg LX3305 QD

Drug

200 mg LX3305 once daily in capsule form

250 mg LX3305 QD

Drug

250 mg LX3305 once daily in capsule form

300 mg LX3305 QD

Drug

300 mg LX3305 once daily in capsule form

400 mg LX3305 QD

Drug

400 mg LX3305 once daily in capsule form

250 mg LX3305 BID

Drug

250 mg LX3305 twice daily in capsule form

500 mg LX3305 QD

Drug

500 mg LX3305 once daily in capsule form

Placebo

Drug

Matching placebo dosing in capsule form

Primary outcomes

  1. Number of subjects experiencing an adverse event (AE)

    Time frame: 14 weeks

Secondary outcomes

  1. Change from baseline in absolute lymphocyte counts

    Time frame: 14 weeks

  2. Maximum observed plasma concentration

    Time frame: 14 weeks

  3. Time at which maximum observed plasma concentration occurs

    Time frame: 14 weeks

  4. Half-life of drug in plasma

    Time frame: 14 weeks

  5. Changes from baseline in global health

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2011
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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