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

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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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 May 16, 2013