GoutPhase 2NCT01399008
Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
A Phase 2 study testing Arhalofenate, Allopurinol and Colchicine in people with Gout, run by Gilead Sciences at 24 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- Arhalofenate, Allopurinol and Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Jun 2011to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known gout patients (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
- Patients who have been taking at least 200 mg/day of allopurinol as the sole ULT for at least two weeks with a sUA of ≥ 6.5 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.
- -OR -
- Patients who are not on ULT or are taking allopurinol < 200 mg/day must have a sUA ≥ 8.0 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.
- Male or female, 18-75 years of age at screening
- All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least six months and serum FSH ≥ 40 mIU/mL) or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless she reports complete sexual abstinence.
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- Female patients must not be pregnant or lactating.
- Male patients with a female partner of child-bearing potential must agree to use condoms or the partner must use a medically acceptable method of contraception for the entire duration of the study.
- Estimated creatinine clearance (CrCl) by Cockcroft-Gault method ≥ 60 mL/min at screening
- Serum creatinine value ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males
- Liver function tests ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X ULN for GGT; and ≤ 3X ULN for CK
- All other clinical laboratory parameters must be within normal limits or considered not clinically significant for participation in this study.
- Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant for participation in this study.
- Systolic blood pressure ≤ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg; known hypertensive patients controlled with medications other than thiazide diuretics (blood pressure [BP] reading as above) may be included
Who cannot join
- Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone, febuxostat, or pegloticase) within 30 days of the Screening Visit
- Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant)
- Diagnosis of xanthinuria
- History of documented or suspected kidney stones
- Known infection with HIV or history of viral hepatitis type B or C
- History of illicit drug or alcohol abuse within 1 year of screening
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- History of significant pulmonary disease, upper GI bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within three years of screening
- History of stroke, TIA, acute MI, congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within five years of screening
- Malignancy (except treated basal cell carcinoma) within five years of screening
- BMI > 42 kg/m2
- Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day)
- Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
- Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6), cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones, diuretics, atypical antipsychotic agents, ampicillin, amoxicillin or phenytoin
- Chronic treatment with NSAIDs (use to treat acute flares are permitted).
- Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat acute flare
- Known hypersensitivity to allopurinol, colchicine, or aspirin
- Treatment with any other investigational therapy within the 30 days prior to screening, or patients who received at least one dose of study drug while enrolled in any previous or concomitant MBX-102 trial
- Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator and/or medical monitor.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States16 sites
Study site
Baltimore, Maryland
Study site
Boca Raton, Florida
Study site
Brockton, Massachusetts
Study site
Cincinnati, Ohio
Study site
Durham, North Carolina
Study site
Hartsdale, New York
Study site
Honolulu, Hawaii
Study site
Jacksonville, Florida
Study site
Lincoln, California
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
New York, New York
Study site
Palo Alto, California
Study site
San Antonio, Texas
Study site
St Louis, Missouri
Study site
West Jordan, Utah
Canada7 sites
Study site
Burnaby, British Columbia
Study site
London, Ontario
Study site
Mirabel, Quebec
Study site
Sarnia, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Thornhill, Ontario
Study site
Toronto, Ontario
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in Combination With Allopurinol in Gout Patients With an Inadequate Hypouricemic Response to Allopurinol Alone
The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.
- Conditions
- Gout
- Being tested
- Arhalofenate, Allopurinol, Colchicine, Placebo
- Keywords
- Hyperuricemia
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArhalofenateDrug
Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks
AllopurinolDrug
Allopurinol 300 mg as active comparator
ColchicineDrug
0.6 mg colchicine daily as flare prophylaxis
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arhalofenate 400 mg | Experimental | Arhalofenate 400 mg plus allopurinol 300 mg Receives: Drug: Arhalofenate; Drug: Allopurinol; Drug: Colchicine |
| Arhalofenate 600 mg | Experimental | Arhalofenate 600 mg plus allopurinol 300 mg Receives: Drug: Arhalofenate; Drug: Allopurinol; Drug: Colchicine |
| Allopurinol | Active comparator | Placebo plus Allopurinol 300 mg Receives: Drug: Allopurinol; Drug: Colchicine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Uric Acid
Percent change from baseline in serum uric acid in Per Protocol population
Measured: Percent change from baseline in serum uric acid at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399008
- Sponsor's protocol ID
- M102-21123
- Status last verified
- Sep 2015
- First submitted
- 13 Jul 2011
- Last updated
- 18 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in Combination With Allopurinol in Gout Patients With an Inadequate Hypouricemic Response to Allopurinol Alone
- ClinicalTrials.gov ID
- NCT01399008
- Acronym / sponsor ID
- M102-21123
- Conditions
- Gout
- Keywords
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arhalofenate 400 mg | Experimental | Drug: Arhalofenate, Drug: Allopurinol, Drug: ColchicineArhalofenate 400 mg plus allopurinol 300 mg |
| Arhalofenate 600 mg | Experimental | Drug: Arhalofenate, Drug: Allopurinol, Drug: ColchicineArhalofenate 600 mg plus allopurinol 300 mg |
| Allopurinol | Active comparator | Drug: Allopurinol, Drug: Colchicine, Drug: PlaceboPlacebo plus Allopurinol 300 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Known gout patients (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
- -OR -
- Male or female, 18-75 years of age at screening
- All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least six months and serum FSH ≥ 40 mIU/mL) or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless she reports complete sexual abstinence.
- Female patients must not be pregnant or lactating.
Key exclusion criteria (18 listed)
- Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone, febuxostat, or pegloticase) within 30 days of the Screening Visit
- Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant)
- Diagnosis of xanthinuria
- History of documented or suspected kidney stones
- Known infection with HIV or history of viral hepatitis type B or C
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 |
|---|---|---|
| ArhalofenateArhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks | Drug | Arhalofenate 400 mg, Arhalofenate 600 mg |
| AllopurinolAllopurinol 300 mg as active comparator | Drug | Allopurinol, Arhalofenate 400 mg, Arhalofenate 600 mg |
| Colchicine0.6 mg colchicine daily as flare prophylaxis | Drug | Allopurinol, Arhalofenate 400 mg, Arhalofenate 600 mg |
| PlaceboPlacebo | Drug | Allopurinol |
Primary outcome
Serum Uric Acid
Time frame: Percent change from baseline in serum uric acid at Week 4
Percent change from baseline in serum uric acid in Per Protocol population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arhalofenate, Allopurinol and Colchicine in people with Gout, run by Gilead Sciences at 24 sites in 3 countries.
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 14 inclusion and 18 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, Georgia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Uric Acid (time frame: Percent change from baseline in serum uric acid at Week 4). 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 18 Sep 2015.