NCT03369262

PoC Study of OBE022 in Threatened Preterm Labour

A Phase 2a, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of OBE022 added-on to Atosiban, After Oral Administration in Pregnant Women With Threatened Spontaneous Preterm Labour

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	OBE022	Oral
DRUG	Placebos	Oral
DRUG	Atosiban	I.V.

Timeline

• Start date: 2018-01-10
• Primary completion: 2020-07-08
• Completion: 2022-08-01
• First posted: 2017-12-11
• Last updated: 2021-06-07

Locations

18 sites across 6 countries: Czechia, Finland, Israel, Russia, Spain, Vietnam