AstraZeneca announced top-line results for two pivotal Phase 3 trials, CLEAR1 and CLEAR2 investigating lesinurad, a selective uric acid-re-absorption inhibitor (SURI), when used in combination with xanthine oxidare (XO) inhibitor allopurinol in patients with symptomatic gout not achieving target sUA levels on current allopurinol dose. Lesinurad is an investigational agent that inhibits the uric acid transporter URAT1 in the kidney, increasing uric acid excretion and thereby lowering sUA.
CLEAR1 and CLEAR2 (Combining Lesinurad with Allopurinol in Inadequate Responders) were 12-month multicenter, randomized, placebo-controlled studies (n=603 and n=610, respectively) comparing the efficacy and safety of lesinurad when added to the patient’s current stable medically-appropriate dose of allopurinol compared to placebo plus allopurinol. Patients entering either trial had multiple sUA levels above target and had also reported at least two gout flares in the 12 months prior to randomization.
In both trials, lesinurad 200mg and 400mg, in combination with allopurinol, met the primary endpoint with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone (CLEAR1: 28%, 54% and 59%; CLEAR2: 23%, 55% and 67% for allopurinol alone, lesinurad 200mg + allopurinol and lesinurad 400mg + allopurinol respectively).
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