A Phase 2a, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of OBE022 added-on to Atosiban, After Oral Administration in Pregnant Women With Threatened Spontaneous Preterm Labour
试验速览
- 阶段
- 2 期
- 发起方
- ObsEva SA
- 入组人数
- 115
- 试验地点
- 18
- 主要终点
- Incidence of delivery within 2 days (48 h) from start of IMP administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Matching placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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:
- •positive IGFBP-1 or fœtal Fibronectin test
- •cervical length ≤ 25mm
- •progressive cervical change
排除标准
- •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:
- •Premature rupture of membranes
- •Evidence or suspicion of abruptio placenta
- •Signs and/or symptoms of chorio-amnionitis
- •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
研究组 & 干预措施
Active
OBE022 plus atosiban:
OBE022 will be given orally from Day 1 to Day 7. OBE022 treatment will be initiated ideally simultaneously or at a maximum within 24 h after atosiban start.
- Loading dose: 1 000 mg on Day 1.
- Maintenance dose on Day 1: 500 mg in the evening if loading dose was administered in the morning. If loading dose was administered in the afternoon, then the next dose will take place on the morning of Day 2.
- Maintenance dose from Day 2 to Day 7: 500 mg twice a day (only morning dose on Day 7)
Atosiban will be administered over 48h as per label.
干预措施: OBE022 (Drug)
Active
OBE022 plus atosiban:
OBE022 will be given orally from Day 1 to Day 7. OBE022 treatment will be initiated ideally simultaneously or at a maximum within 24 h after atosiban start.
- Loading dose: 1 000 mg on Day 1.
- Maintenance dose on Day 1: 500 mg in the evening if loading dose was administered in the morning. If loading dose was administered in the afternoon, then the next dose will take place on the morning of Day 2.
- Maintenance dose from Day 2 to Day 7: 500 mg twice a day (only morning dose on Day 7)
Atosiban will be administered over 48h as per label.
干预措施: Atosiban (Drug)
Placebo
OBE022 matching placebo plus atosiban:
OBE022 matching placebo administration will follow the same regimen as the active group.
Atosiban will be administered over 48h as per label.
干预措施: Placebos (Drug)
Placebo
OBE022 matching placebo plus atosiban:
OBE022 matching placebo administration will follow the same regimen as the active group.
Atosiban will be administered over 48h as per label.
干预措施: Atosiban (Drug)
结局指标
主要结局
Incidence of delivery within 2 days (48 h) from start of IMP administration
时间窗: 48 hours
Incidence of delivery within 7 days (168 h) from start of IMP administration
时间窗: 168 hours
Incidence of delivery before 37 weeks of GA
时间窗: Up to 13 weeks from start of IMP administration
Time to delivery measured from start of IMP administration
时间窗: Up to 17 weeks from start of IMP administration
次要结局
未报告次要终点