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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014