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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01417052
First received: August 12, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Rheumatoid Arthritis
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Number of subjects experiencing an adverse event (AE) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in absolute lymphocyte counts [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Time at which maximum observed plasma concentration occurs [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Half-life of drug in plasma [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in global health [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg LX3305 QD Drug: 50 mg LX3305 QD
50 mg LX3305 once daily in capsule form
Experimental: 100 mg LX3305 QD Drug: 100 mg LX3305 QD
100 mg LX3305 once daily in capsule form
Experimental: 150 mg LX3305 QD Drug: 150 mg LX3305 QD
150 mg LX3305 once daily in capsule form
Experimental: 200 mg LX3305 QD Drug: 200 mg LX3305 QD
200 mg LX3305 once daily in capsule form
Experimental: 250 mg LX3305 QD Drug: 250 mg LX3305 QD
250 mg LX3305 once daily in capsule form
Experimental: 300 mg LX3305 QD Drug: 300 mg LX3305 QD
300 mg LX3305 once daily in capsule form
Experimental: 400 mg LX3305 QD Drug: 400 mg LX3305 QD
400 mg LX3305 once daily in capsule form
Experimental: 250 mg LX3305 BID Drug: 250 mg LX3305 BID
250 mg LX3305 twice daily in capsule form
Experimental: 500 mg LX3305 QD Drug: 500 mg LX3305 QD
500 mg LX3305 once daily in capsule form
Placebo Comparator: Placebo Drug: Placebo
Matching placebo dosing in capsule form

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417052

Locations
United States, Texas
Lexicon Investigational Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Joel Freiman, MD, MPH Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01417052     History of Changes
Other Study ID Numbers: LX3305.1-106-RA, LX3305.106
Study First Received: August 12, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014