Topline results from both studies are expected in
“Completion of enrollment in our SOOTHE trial marks an important milestone, underscoring the progress we have made advancing BLU-5937 for the treatment of RCC. As recently reported, we are encouraged by the positive outcome of our recent administrative interim analysis from the SOOTHE trial, and look forward to sharing topline results from both SOOTHE and our Phase 2a BLUEPRINT trial in chronic pruritus in December 2021,” said
The SOOTHE trial is a multicenter, randomized, double-blind, four-week, parallel arm, placebo-controlled Phase 2b trial evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 310 participants with RCC. A total of 249 participants with a baseline awake cough frequency of ≥25 awake coughs per hour were randomized across four arms (1:1:1:1) evaluating the three active doses of BLU-5937 and placebo in the main study. Treatment arms were stratified to balance the number of participants with baseline awake cough frequency ≥45 coughs per hour across trial arms. The primary efficacy endpoint is the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder. An exploratory group of an additional 61 participants with a baseline awake cough frequency of ≥10 and <25 coughs per hour were randomized across 2 arms (1:1) evaluating one active dose (200 mg BID) and placebo to further investigate the effect of BLU-5937 in patients with lower cough frequency. More information about the trial is available at www.clinicaltrials.gov: NCT04678206.
The BLUEPRINT trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-design Phase 2a trial evaluating the efficacy, safety and tolerability of BLU-5937 in 142 participants with moderate to severe chronic pruritus associated with mild to moderate AD. Participants were randomized into one of two treatment arms (1:1) and receive either 200 mg BID of BLU-5937 or placebo for a four-week treatment period. The primary efficacy endpoint is the change from baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS) score at week four. A key secondary endpoint is a responder-rate analysis of at least four-point WI-NRS improvement from baseline at week four. More information about the trial is available at www.clinicaltrials.gov: NCT04693195.
RCC is a cough lasting more than 8 weeks despite appropriate treatment for underlying condition(s). It is estimated that there are approximately 9 million patients in
Chronic pruritus associated with AD is an irritating sensation that leads to scratching and persists for longer than 6 weeks in AD patients. It is estimated that up to 10% of adults in
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