BioCentury
ARTICLE | Clinical News

DSMB recommends continuation of RedHill's Phase III trial of RHB-104 for CD

August 18, 2017 7:50 PM UTC

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) said an independent DSMB recommend for a second time continuation of the Phase III MAP US trial of RHB-104 to treat Crohn’s disease (CD) based on efficacy and safety data from the trial’s first 222 patients who completed 26-week assessments. Last year, an independent DSMB recommended the trial’s continuation based on a safety review (see BioCentury, Jan. 9).

The double-blind, international trial is evaluating twice-daily oral RHB-104 compared to placebo. The company expects to complete enrollment of 410 patients next half. The trial’s primary endpoint is remission, defined as a reduction in total CD Activity Index (CDAI) score to <150 points, at week 26. Secondary endpoints include response, defined as a reduction in CDAI score of ≥100 points, at week 26; time to and duration of remission and response and maintenance of remission through week 52...

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