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Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout

Information source: CymaBay Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperuricemia; Gout

Intervention: Arhalofenate (Drug); Arhalofenate (Drug); Placebo comparator (Drug); Colchicine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: CymaBay Therapeutics, Inc.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Serum uric acid

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

- 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 Exclusion Criteria:

- 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

- 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

Locations and Contacts

Tucson, Arizona, United States

Los Angeles, California, United States

Boca Raton, Florida, United States

Jupiter, Florida, United States

Tampa, Florida, United States

Honolulu, Hawaii, United States

Wheaton, Maryland, United States

St. Louis, Missouri, United States

New York, New York, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

West Jordan, Utah, United States

Additional Information

Starting date: May 2011
Last updated: March 30, 2015

Page last updated: August 20, 2015

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