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.
Phase:
Phase 2
Details
Lead Sponsor:
ObsEva SA
Collaborators:
Cytel Inc. Iqvia Pty Ltd PHINC DEVELOPMENT SCOPE International AG