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Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Information source: CymaBay Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

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

Phase: Phase 2

Status: Completed

Sponsored by: CymaBay Therapeutics, Inc.

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.

Clinical Details

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

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

Primary outcome: Serum Uric Acid

Eligibility

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

Criteria:

Inclusion Criteria: 1. Known gout patients (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout 1. 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 -

2. 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.

2. Male or female, 18-75 years of age at screening 3. 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. 4. Female patients must not be pregnant or lactating. 5. 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. 6. Estimated creatinine clearance (CrCl) by Cockcroft-Gault method ≥ 60 mL/min at screening 7. Serum creatinine value ≤ 1. 1 mg/dL in females and ≤ 1. 3 mg/dL in males 8. 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 9. All other clinical laboratory parameters must be within normal limits or considered not clinically significant for participation in this study. 10. Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant for participation in this study. 11. 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 Exclusion Criteria: 1. Treatment with any ULT other than allopurinol (e. g., probenecid, benzbromarone, febuxostat, or pegloticase) within 30 days of the Screening Visit 2. Known or suspected secondary hyperuricemia (e. g. due to myeloproliferative disorder, or organ transplant) 3. Diagnosis of xanthinuria 4. History of documented or suspected kidney stones 5. Known infection with HIV or history of viral hepatitis type B or C 6. History of illicit drug or alcohol abuse within 1 year of screening 7. 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 8. 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 9. Malignancy (except treated basal cell carcinoma) within five years of screening 10. BMI > 42 kg/m2 11. Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day) 12. Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment 13. 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 14. Chronic treatment with NSAIDs (use to treat acute flares are permitted). 15. 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 16. Known hypersensitivity to allopurinol, colchicine, or aspirin 17. 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 18. 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

Tiblisi, Georgia

Burnaby, British Columbia, Canada

Lincoln, California, United States

Los Angeles, California, United States

Palo Alto, California, United States

Boca Raton, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Brockton, Massachusetts, United States

St. Louis, Missouri, United States

Hartsdale, New York, United States

New York, New York, United States

St. Johns, Newfoundland and Labrador, Canada

Durham, North Carolina, United States

Cincinnati, Ohio, United States

London, Ontario, Canada

Sarnia, Ontario, Canada

Thornhill, Ontario, Canada

Toronto, Ontario, Canada

Mirabel, Quebec, Canada

San Antonio, Texas, United States

West Jordan, Utah, United States

Additional Information

Starting date: June 2011
Last updated: March 11, 2015

Page last updated: August 23, 2015

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