Rheumatoid ArthritisPhase 1NCT01417052
A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis
A Phase 1 study testing 50 mg LX3305 QD, 100 mg LX3305 QD and 150 mg LX3305 QD in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 50 mg LX3305 QD, 100 mg LX3305 QD and 150 mg LX3305 QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- 50 mg LX3305 QD, 100 mg LX3305 QD, 150 mg LX3305 QD, 200 mg LX3305 QD, 250 mg LX3305 QD
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg LX3305 QDDrug
50 mg LX3305 once daily in capsule form
100 mg LX3305 QDDrug
100 mg LX3305 once daily in capsule form
150 mg LX3305 QDDrug
150 mg LX3305 once daily in capsule form
200 mg LX3305 QDDrug
200 mg LX3305 once daily in capsule form
250 mg LX3305 QDDrug
250 mg LX3305 once daily in capsule form
300 mg LX3305 QDDrug
300 mg LX3305 once daily in capsule form
400 mg LX3305 QDDrug
400 mg LX3305 once daily in capsule form
250 mg LX3305 BIDDrug
250 mg LX3305 twice daily in capsule form
500 mg LX3305 QDDrug
500 mg LX3305 once daily in capsule form
PlaceboDrug
Matching placebo dosing in capsule form
| Study group | Role | What they receive |
|---|---|---|
| 50 mg LX3305 QD | Experimental | Not described Receives: Drug: 50 mg LX3305 QD |
| 100 mg LX3305 QD | Experimental | Not described Receives: Drug: 100 mg LX3305 QD |
| 150 mg LX3305 QD | Experimental | Not described Receives: Drug: 150 mg LX3305 QD |
| 200 mg LX3305 QD | Experimental | Not described Receives: Drug: 200 mg LX3305 QD |
| 250 mg LX3305 QD | Experimental | Not described Receives: Drug: 250 mg LX3305 QD |
| 300 mg LX3305 QD | Experimental | Not described Receives: Drug: 300 mg LX3305 QD |
| 400 mg LX3305 QD | Experimental | Not described Receives: Drug: 400 mg LX3305 QD |
| 250 mg LX3305 BID | Experimental | Not described Receives: Drug: 250 mg LX3305 BID |
| 500 mg LX3305 QD | Experimental | Not described Receives: Drug: 500 mg LX3305 QD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing an adverse event (AE)
Measured: 14 weeks
Secondary outcomes (5)
Change from baseline in absolute lymphocyte counts
Measured: 14 weeks
Maximum observed plasma concentration
Measured: 14 weeks
Time at which maximum observed plasma concentration occurs
Measured: 14 weeks
Half-life of drug in plasma
Measured: 14 weeks
Changes from baseline in global health
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Freiman, MD, MPH, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417052
- Sponsor's protocol ID
- LX3305.1-106-RA
- Other IDs
- LX3305.106
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01417052
- Acronym / sponsor ID
- LX3305.1-106-RA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg LX3305 QD50 mg LX3305 once daily in capsule form | Drug | 50 mg LX3305 QD |
| 100 mg LX3305 QD100 mg LX3305 once daily in capsule form | Drug | 100 mg LX3305 QD |
| 150 mg LX3305 QD150 mg LX3305 once daily in capsule form | Drug | 150 mg LX3305 QD |
| 200 mg LX3305 QD200 mg LX3305 once daily in capsule form | Drug | 200 mg LX3305 QD |
| 250 mg LX3305 QD250 mg LX3305 once daily in capsule form | Drug | 250 mg LX3305 QD |
| 300 mg LX3305 QD300 mg LX3305 once daily in capsule form | Drug | 300 mg LX3305 QD |
| 400 mg LX3305 QD400 mg LX3305 once daily in capsule form | Drug | 400 mg LX3305 QD |
| 250 mg LX3305 BID250 mg LX3305 twice daily in capsule form | Drug | 250 mg LX3305 BID |
| 500 mg LX3305 QD500 mg LX3305 once daily in capsule form | Drug | 500 mg LX3305 QD |
| PlaceboMatching placebo dosing in capsule form | Drug | Placebo |
Primary outcome
Number of subjects experiencing an adverse event (AE)
Time frame: 14 weeks
5 secondary outcomes
Change from baseline in absolute lymphocyte counts
Time frame: 14 weeks
Maximum observed plasma concentration
Time frame: 14 weeks
Time at which maximum observed plasma concentration occurs
Time frame: 14 weeks
Half-life of drug in plasma
Time frame: 14 weeks
Changes from baseline in global health
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Freiman, MD, MPH study director
Lexicon Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mg LX3305 QD, 100 mg LX3305 QD and 150 mg LX3305 QD in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing an adverse event (AE) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.