Clinical trial NCT01417052: A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: Number of subjects experiencing an adverse event (AE)
timeFrame: 14 weeks
Secondary outcomes:
measure: Change from baseline in absolute lymphocyte counts
timeFrame: 14 weeks
measure: Maximum observed plasma concentration
timeFrame: 14 weeks
measure: Time at which maximum observed plasma concentration occurs
timeFrame: 14 weeks
measure: Half-life of drug in plasma
timeFrame: 14 weeks
measure: Changes from baseline in global health
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Joel Freiman, MD, MPH
role: STUDY_DIRECTOR
References: