HyperuricemiaPhase 2NCT01336686
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
A Phase 2 study testing Arhalofenate and Colchicine in people with Hyperuricemia and Gout, run by Gilead Sciences at 12 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- Arhalofenate and Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 2
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
- Read and sign the informed consent after the elements of consent have been fully explained and all questions have been addressed, prior to any study procedures.
- Known gout patient (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout in Appendix 3)
- the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL
- if on ULT, the patients must agree to temporarily discontinue their existing ULT and the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL after wash-out at Week -1
- Male or female, 18-75 years of age at Screening Visit
- 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 6 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 reporting 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 condom or the partner must use a medically acceptable method of contraception for the entire duration of the study.
- Patients must have an estimated CrCl ≥ 60 mL/min as calculated by the Cockcroft-Gault method
- Serum creatinine value must be ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males
- Patients must have 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
- Patients must have a systolic blood pressure ≤ 160 mm Hg and a diastolic blood pressure ≤ 90 mm Hg; known hypertensive patients controlled with medication other than thiazide diuretics (BP reading as above) may be included
Who cannot join
- Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant).
- Known patient with xanthinuria
- History of documented or suspected kidney stones
- Over producers of uric acid as evidenced by 24-hour urinary uric acid > 800 mg (on normal unrestricted diet)
- Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
- History of illicit drug or alcohol abuse within last 1 year
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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 last 3 years
- All patients must not have had a stroke, TIA, acute myocardial infarction, 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 last 5 years
- Malignancy within the last 5 years (except resected basal cell carcinoma)
- Body mass index (BMI) > 42 kg/m2
- Current or expected requirement for anticoagulant therapy (except for ≤ 325 mg/day aspirin and/or Plavix® 75 mg/day)
- Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
- Current or expected treatment with potent CYP3A4 inhibitors (See in Appendix 6), ranolazine, digoxin, cyclosporine, cyclophosphamide and other cytotoxic agents, sulphonylurea, thiazolidinedione, diuretic, atypical antipsychotic agents, and phenytoin
- Chronic treatment with non-steroidal anti-inflammatory drugs (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 flares
- Known hypersensitivity to colchicine
- Treatment with any other investigational therapy within the 30 days prior to the Screening Visit, or patients who received at least one dose of blinded study drug while enrolled in any previous 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Boca Raton, Florida
Study site
Cincinnati, Ohio
Study site
Honolulu, Hawaii
Study site
Jupiter, Florida
Study site
Los Angeles, California
Study site
New York, New York
Study site
Raleigh, North Carolina
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
West Jordan, Utah
Study site
Wheaton, Maryland
About this study
Official title: A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in the Treatment of Hyperuricemia in Patients With Gout
The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.
- Conditions
- Hyperuricemia, Gout
- Being tested
- Arhalofenate, Placebo comparator, Colchicine
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArhalofenateDrug
Also called MBX-102
Arhalofenate 400 mg once daily for 4 weeks
ArhalofenateDrug
Also called MBX-102
Arhalofenate 600 mg once daily for 4 weeks
Placebo comparatorDrug
Matching placebo once daily for 4 weeks
ColchicineDrug
0.6 mg colchicine daily for flare prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Arhalofenate 400 mg | Experimental | Not described Receives: Drug: Arhalofenate; Drug: Colchicine |
| Arhalofenate 600 mg | Experimental | Not described Receives: Drug: Arhalofenate; Drug: Colchicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo comparator; Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid
Measured: Baseline and end of treatment phase (4 wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 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
- NCT01336686
- Sponsor's protocol ID
- M102-21122
- Status last verified
- Mar 2015
- First submitted
- 14 Apr 2011
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No