NCT01417052

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

August 12, 2011

Last Update Submit

August 1, 2012

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of subjects experiencing an adverse event (AE)

    14 weeks

Secondary Outcomes (5)

  • Change from baseline in absolute lymphocyte counts

    14 weeks

  • Maximum observed plasma concentration

    14 weeks

  • Time at which maximum observed plasma concentration occurs

    14 weeks

  • Half-life of drug in plasma

    14 weeks

  • Changes from baseline in global health

    14 weeks

Study Arms (10)

50 mg LX3305 QD

EXPERIMENTAL
Drug: 50 mg LX3305 QD

100 mg LX3305 QD

EXPERIMENTAL
Drug: 100 mg LX3305 QD

150 mg LX3305 QD

EXPERIMENTAL
Drug: 150 mg LX3305 QD

200 mg LX3305 QD

EXPERIMENTAL
Drug: 200 mg LX3305 QD

250 mg LX3305 QD

EXPERIMENTAL
Drug: 250 mg LX3305 QD

300 mg LX3305 QD

EXPERIMENTAL
Drug: 300 mg LX3305 QD

400 mg LX3305 QD

EXPERIMENTAL
Drug: 400 mg LX3305 QD

250 mg LX3305 BID

EXPERIMENTAL
Drug: 250 mg LX3305 BID

500 mg LX3305 QD

EXPERIMENTAL
Drug: 500 mg LX3305 QD

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

50 mg LX3305 QDDRUG

50 mg LX3305 once daily in capsule form

50 mg LX3305 QD
100 mg LX3305 QDDRUG

100 mg LX3305 once daily in capsule form

100 mg LX3305 QD
150 mg LX3305 QDDRUG

150 mg LX3305 once daily in capsule form

150 mg LX3305 QD
200 mg LX3305 QDDRUG

200 mg LX3305 once daily in capsule form

200 mg LX3305 QD
250 mg LX3305 QDDRUG

250 mg LX3305 once daily in capsule form

250 mg LX3305 QD
300 mg LX3305 QDDRUG

300 mg LX3305 once daily in capsule form

300 mg LX3305 QD
400 mg LX3305 QDDRUG

400 mg LX3305 once daily in capsule form

400 mg LX3305 QD
250 mg LX3305 BIDDRUG

250 mg LX3305 twice daily in capsule form

250 mg LX3305 BID
500 mg LX3305 QDDRUG

500 mg LX3305 once daily in capsule form

500 mg LX3305 QD
PlaceboDRUG

Matching placebo dosing in capsule form

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Joel Freiman, MD, MPH

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 16, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)