MedDataX Logo

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

NCT ID: NCT01417052

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

50 mg LX3305 QD

Group Type EXPERIMENTAL

50 mg LX3305 QD

Intervention Type DRUG

50 mg LX3305 once daily in capsule form

100 mg LX3305 QD

Group Type EXPERIMENTAL

100 mg LX3305 QD

Intervention Type DRUG

100 mg LX3305 once daily in capsule form

150 mg LX3305 QD

Group Type EXPERIMENTAL

150 mg LX3305 QD

Intervention Type DRUG

150 mg LX3305 once daily in capsule form

200 mg LX3305 QD

Group Type EXPERIMENTAL

200 mg LX3305 QD

Intervention Type DRUG

200 mg LX3305 once daily in capsule form

250 mg LX3305 QD

Group Type EXPERIMENTAL

250 mg LX3305 QD

Intervention Type DRUG

250 mg LX3305 once daily in capsule form

300 mg LX3305 QD

Group Type EXPERIMENTAL

300 mg LX3305 QD

Intervention Type DRUG

300 mg LX3305 once daily in capsule form

400 mg LX3305 QD

Group Type EXPERIMENTAL

400 mg LX3305 QD

Intervention Type DRUG

400 mg LX3305 once daily in capsule form

250 mg LX3305 BID

Group Type EXPERIMENTAL

250 mg LX3305 BID

Intervention Type DRUG

250 mg LX3305 twice daily in capsule form

500 mg LX3305 QD

Group Type EXPERIMENTAL

500 mg LX3305 QD

Intervention Type DRUG

500 mg LX3305 once daily in capsule form

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo dosing in capsule form

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

50 mg LX3305 QD

50 mg LX3305 once daily in capsule form

Intervention Type DRUG

100 mg LX3305 QD

100 mg LX3305 once daily in capsule form

Intervention Type DRUG

150 mg LX3305 QD

150 mg LX3305 once daily in capsule form

Intervention Type DRUG

200 mg LX3305 QD

200 mg LX3305 once daily in capsule form

Intervention Type DRUG

250 mg LX3305 QD

250 mg LX3305 once daily in capsule form

Intervention Type DRUG

300 mg LX3305 QD

300 mg LX3305 once daily in capsule form

Intervention Type DRUG

400 mg LX3305 QD

400 mg LX3305 once daily in capsule form

Intervention Type DRUG

250 mg LX3305 BID

250 mg LX3305 twice daily in capsule form

Intervention Type DRUG

500 mg LX3305 QD

500 mg LX3305 once daily in capsule form

Intervention Type DRUG

Placebo

Matching placebo dosing in capsule form

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joel Freiman, MD, MPH

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lexicon Investigational Site

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LX3305.106

Identifier Type: OTHER

Identifier Source: secondary_id

LX3305.1-106-RA

Identifier Type: -

Identifier Source: org_study_id