Can a new drug combo crack Hard-to-Treat gout?
NCT ID NCT02252835
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing whether arhalofenate, an experimental drug, can safely be combined with febuxostat to lower uric acid in adults with gout. The trial enrolls 32 people with gout and high uric acid levels. Participants receive both drugs at different doses over several weeks, and researchers measure how much uric acid drops and how the drugs interact in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- arhalofenate, an experimental gout drug, tested alone and with febuxostat
- What this could lead to
- If the combination works, it could offer a new way to lower uric acid in people whose gout is hard to control with standard drugs alone.
- What could go wrong
- This is a small, early-stage study of 32 people, so results may not hold in larger groups. Combining drugs can change how each one behaves in the body, which may reduce benefit or increase side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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32 people
The number who actually took part.
- Start date
-
Aug 2014
- Finished
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Dec 2014
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patient, 18 to 75 years of age, inclusive * Known gout diagnosis (per criteria of the American Rheumatism Association) * Has an sUA ≥ 7.5 mg/dL * A female patient must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least two years), or must agree to use two medically accepted methods of contraception including a barrier method for the entire duration of study participation unless she reports compete sexual abstinence. A female patient must also not be pregnant or lactating * Estimated creatinine clearance (eCrCl) ≥ 60 ml/min, as calculated by Cockcroft-Gault method * ALT or AST ≤ 3 times upper limit of normal (ULN) or total bilirubin ≤ 2 times ULN (Gilbert's syndrome is permitted) * All other clinical laboratory parameters must be within normal limits or considered not clinically significant * ECG must be normal, or if abnormal, considered not clinically significant * A patient who is taking a medication or agent (other than a ULT) known to influence sUA levels must be on a stable dose and regimen of the medication for at least two weeks prior to screening and must be willing to continue the same dose and regimen during study participation * Expected to be able to tolerate a short course of oral NSAIDs and/or oral steroids as may be needed to treat a gout flare * Must be able to swallow tablets Exclusion Criteria: * Treatment with any ULT (e.g., allopurinol, febuxostat, probenecid, or benzbromarone) within two weeks, or pegloticase within six months, prior to the sUA assessment at Day 1 * Occurrence of a gout flare that has not resolved within one week prior to Day 1 * Known or suspected secondary hyperuricemia (e.g., due to myeloproliferative disorder or organ transplant) * Diagnosis of xanthinuria * Fractional excretion of urate \> 10% * History of documented or suspected kidney stones within five years prior to screening * Known infection with the human immunodeficiency virus (HIV) or history of hepatitis B or C * Recent use/abuse of an illicit drug as determined by a positive urine drug screen * Uncontrolled hypertension that, in the opinion of the Investigator, would preclude participation in the study * History of stroke, transient ischemic attack, acute myocardial infarction, congestive heart failure (NYHA class II - IV), angina pectoris, coronary intervention procedure, lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within 5 years of screening * History of cancer within five years of screening, with the following exceptions: adequately treated non-melanoma skin cancer, non-metastatic prostate cancer, or in situ cervical cancer * Body mass index (BMI) \> 42 kg/m2 * Current or expected requirement for anticoagulant therapy, except for low dose (≤ 81 mg/day) aspirin, clopidogrel (Plavix) ≤ 75 mg/day, or prasugrel (Effient) ≤ 10 mg/day * Use of any of the following within eight weeks prior to screening: potent CYP3A4 inhibitors, cytotoxic agents (including azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones (e.g., rosiglitazone or pioglitazone), desipramine, atypical antipsychotic agents, loop diuretics, warfarin, or phenytoin * Chronic treatment with NSAIDs that cannot be safely discontinued-term use of NSAIDs is permitted, e.g., when used to treat gout flares * Known hypersensitivity or intolerance to febuxostat or colchicine * Treatment with any other investigational therapy within 30 days or within five half-lives, whichever is longer prior to Day 1 * Any other condition that would compromise the safety of the patient, prevent compliance with the study protocol, or compromise the quality of the clinical study, as judged by the Investigator and/or Medical Monitor
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vince & Associates Clinical Research
Overland Park, Kansas, 66212, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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