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

A Phase 2, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Safety and Efficacy of OBE001 After Oral Administration in Pregnant Women With Threatened Preterm Labour.

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.

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.