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

Phase 2TerminatedNCT02326142

ObsEva SA10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Labor

Interventions

OBE001DRUG

OBE001 dispersible tablets for a single oral dose a day for up to 7 days.

PlaceboDRUG

Placebo dispersible tablets for a single oral dose a day for up to 7 days.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Unnamed facility

Brussels, Belgium

Unnamed facility

Leuven, Belgium

Unnamed facility

Liège, Belgium

Outcomes

Primary Outcomes

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

Time frame: within 7 days of first dose

Secondary Outcomes

EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose

Time frame: within 48 hours of first dose

EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks

Time frame: 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

Contractions measured by tocodynamometry.

Time frame: up to 24 hours post first dose

EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)

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.

Time frame: up to 7 weeks post first dose

Data from ClinicalTrials.gov

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