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6-K
OBSEVA SA filed this Form 6-K on 03/30/2018
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LOGO

 

OBE2109 Phase 2b clinical trial (EDELWEISS) in endometriosis patients Primary endpoint: VRS pain score responder rate 8–14 weeks LEAD-IN 12 weeks Placebo 50 mg daily 75 mg daily 100 mg daily 200 mg daily 75 mg daily* Mid 2018 Key secondary endpoint: BMD 12 weeks 50 mg daily 75 mg daily 100 mg daily 200 mg daily * Titrated dose 50–100 mg 24 weeks FOLLOW-UP Optional extension 6 m + 6m f-up * Titration after 12 weeks based on E2 serum level at weeks 4 and 8 Target enrollment of 330 patients • ~70 sites in US (>50% of patients) • 15 sites in EU Recruitment completed November 2017