PoC Study of OBE022 in Threatened Preterm Labour

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA
• Collaborators: Cytel Inc.; Iqvia Pty Ltd; PHINC DEVELOPMENT; SCOPE International AG
• Treatments: Atosiban

Criteria

Key Inclusion Criteria:

Part A

• Pregnant females aged ≥ 18 years

• Patients with a singleton or twin pregnancy

• Gestational age between 28 0/7 and 33 6/7

• Administered or prescribed atosiban for the treatment of preterm labour

Part B

• Pregnant females aged ≥ 18 years

• Patients with a singleton or twin pregnancy

• Gestational age between 24 0/7 and 33 6/7

• Administered or prescribed atosiban for the treatment of preterm labour

• ≥4 uterine contractions per 30 minutes

• Cervical dilatation of 1 to 4 cm inclusive

• At least one of the following signs of preterm labour:

1. positive IGFBP-1 or fœtal Fibronectin test

2. cervical length ≤ 25mm

3. progressive cervical change

Key Exclusion Criteria:

• Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days

• Oligohydramnios

• Known pathological Doppler ultrasound of the umbilical artery

• Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:

1. Premature rupture of membranes

2. Evidence or suspicion of abruptio placenta

3. Signs and/or symptoms of chorio-amnionitis

4. Pre-eclampsia, eclampsia or HELLP-syndrome

• Use of cervical cerclage in the current pregnancy or a pessary in situ

• Current use of anti-hypertensive medication

• Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions