Efficacy and Safety of Eliapixant in Endometriosis-Associated Pelvic Pain: The SCHUMANN Study
Published in BMC Women’s Health, June 19, 2024
Background: The SCHUMANN study assessed the effectiveness and safety of eliapixant in treating endometriosis-associated pelvic pain (EAPP).
Methods: This was a phase 2b study involving women with surgically diagnosed endometriosis and EAPP. Participants were randomly assigned to receive eliapixant at different doses or a placebo for 12 weeks. The primary goal was to measure the change in worst EAPP from baseline to the end of the study.
Results: The study was terminated early due to safety concerns, with fewer participants completing the study than planned. No significant differences in EAPP reduction were found between the treatment groups, and the elagolix 150 mg group showed better pain reduction. While eliapixant was generally well tolerated, one participant receiving the highest dose experienced drug-induced liver injury, leading to a reassessment of the benefit-risk ratio for the study.
Conclusions: The study did not achieve its primary objective, and the benefit-risk ratio was no longer considered positive due to safety concerns. Clinical trial registration: ClinicalTrials.gov identifier NCT04614246.
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