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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

50 mg LX3305 QD

100 mg LX3305 QD

150 mg LX3305 QD

200 mg LX3305 QD

250 mg LX3305 QD

300 mg LX3305 QD

400 mg LX3305 QD

250 mg LX3305 BID

500 mg LX3305 QD

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Arm Label

50 mg LX3305 QD

100 mg LX3305 QD

150 mg LX3305 QD

200 mg LX3305 QD

250 mg LX3305 QD

300 mg LX3305 QD

400 mg LX3305 QD

250 mg LX3305 BID

500 mg LX3305 QD

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects experiencing an adverse event (AE)

Secondary Outcome Measures

Change from baseline in absolute lymphocyte counts

Maximum observed plasma concentration

Time at which maximum observed plasma concentration occurs

Half-life of drug in plasma

Changes from baseline in global health

Full Information

NCT ID

NCT01417052

First Posted

August 12, 2011

Last Updated

August 1, 2012

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01417052

Brief Title

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg LX3305 QD

Arm Type

Experimental

Arm Title

100 mg LX3305 QD

Arm Type

Experimental

Arm Title

150 mg LX3305 QD

Arm Type

Experimental

Arm Title

200 mg LX3305 QD

Arm Type

Experimental

Arm Title

250 mg LX3305 QD

Arm Type

Experimental

Arm Title

300 mg LX3305 QD

Arm Type

Experimental

Arm Title

400 mg LX3305 QD

Arm Type

Experimental

Arm Title

250 mg LX3305 BID

Arm Type

Experimental

Arm Title

500 mg LX3305 QD

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

50 mg LX3305 QD

Intervention Description

50 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

100 mg LX3305 QD

Intervention Description

100 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

150 mg LX3305 QD

Intervention Description

150 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

200 mg LX3305 QD

Intervention Description

200 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

250 mg LX3305 QD

Intervention Description

250 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

300 mg LX3305 QD

Intervention Description

300 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

400 mg LX3305 QD

Intervention Description

400 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

250 mg LX3305 BID

Intervention Description

250 mg LX3305 twice daily in capsule form

Intervention Type

Drug

Intervention Name(s)

500 mg LX3305 QD

Intervention Description

500 mg LX3305 once daily in capsule form

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo dosing in capsule form

Primary Outcome Measure Information:

Title

Number of subjects experiencing an adverse event (AE)

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in absolute lymphocyte counts

Time Frame

14 weeks

Title

Maximum observed plasma concentration

Time Frame

14 weeks

Title

Time at which maximum observed plasma concentration occurs

Time Frame

14 weeks

Title

Half-life of drug in plasma

Time Frame

14 weeks

Title

Changes from baseline in global health

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Freiman, MD, MPH

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Lexicon Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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