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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Preterm Labor

Intervention / Treatment
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* Drug: OBE001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OBE001<br> | Drug: OBE001<br>* OBE001 dispersible tablets for a single oral dose a day for up to 7 days.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo dispersible tablets for a single oral dose a day for up to 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose |  | within 7 days of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Contractions measured by tocodynamometry. | 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. | up to 7 weeks post first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Obstetric Labor, Premature Birth