This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks. Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks. All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.
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Incidence of delivery within 2 days (48 h) from start of IMP administration
Timeframe: 48 hours
Incidence of delivery within 7 days (168 h) from start of IMP administration
Timeframe: 168 hours
Incidence of delivery before 37 weeks of GA
Timeframe: Up to 13 weeks from start of IMP administration
Time to delivery measured from start of IMP administration
Timeframe: Up to 17 weeks from start of IMP administration