A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth

Phase 2

Terminated

• Conditions: Preterm Labor
• Interventions: Drug: OBE001; Drug: Placebo

• Registration Number: NCT02326142
• Lead Sponsor: ObsEva SA

Brief Summary

The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

Detailed Description

The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34\^0/7 and 35\^6/7 weeks of gestation.

The study will be in 2 parts as follows:

* from screening until the day of delivery (including a treatment period up to seven days)

* a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later).

In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Study Start: 2015-03
• Primary Completion: 2016-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Gestational age (GA) between 34^0/7 and 35^6/7 weeks.
• Subjects with symptoms of preterm labour.
• Subjects with a singleton pregnancy.

Exclusion Criteria

• Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy.
• Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery.
• Use of cervical cerclage or a pessary in situ in the current pregnancy.
• The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OBE001	OBE001	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose	within 7 days of first dose

Secondary Outcome Measures

Name	Time	Method
EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose	within 48 hours of first dose
EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks	up to 3 weeks post first dose
EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose	up to 24 hours post first dose	Contractions measured by tocodynamometry.
EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)	up to 7 weeks post first dose	Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose) on Day 3 (pre-dose), Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery.