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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417052
• Other study ID #: LX3305.1-106-RA
• Secondary ID: LX3305.106
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2011
• Last updated: August 1, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 50 mg LX3305 QD
50 mg LX3305 once daily in capsule form
• 100 mg LX3305 QD
100 mg LX3305 once daily in capsule form
• 150 mg LX3305 QD
150 mg LX3305 once daily in capsule form
• 200 mg LX3305 QD
200 mg LX3305 once daily in capsule form
• 250 mg LX3305 QD
250 mg LX3305 once daily in capsule form
• 300 mg LX3305 QD
300 mg LX3305 once daily in capsule form
• 400 mg LX3305 QD
400 mg LX3305 once daily in capsule form
• 250 mg LX3305 BID
250 mg LX3305 twice daily in capsule form
• 500 mg LX3305 QD
500 mg LX3305 once daily in capsule form
• Placebo
Matching placebo dosing in capsule form

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing an adverse event (AE)		14 weeks	No
Secondary	Change from baseline in absolute lymphocyte counts		14 weeks	No
Secondary	Maximum observed plasma concentration		14 weeks	No
Secondary	Time at which maximum observed plasma concentration occurs		14 weeks	No
Secondary	Half-life of drug in plasma		14 weeks	No
Secondary	Changes from baseline in global health		14 weeks	No