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. - TERM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003217-28-ES

Enrollment

100

Registered

2014-12-16

Start date

2015-01-22

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of preterm labour MedDRA version: 17.1 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Product Name: OBE001 Product Code: OBE001 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: OBE001 CAS Number: 1477482-19-1 Current Sponsor code: OBE001 Other descriptive name: OBE001 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pregnant females aged mayor or equal 18 years. 2. Subjects with a singleton pregnancy. 3. GA between 34 0/7 and 35 6/7 weeks as confirmed by best obstetric estimate, preferably first trimester US scan. 4. Subjects with symptoms of preterm labour 5. Able to communicate well with the investigator and research staff and to comply with the requirements of the entire study. 6. Provision of written informed consent to participate as shown by a signature on the subject consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the coming days. 2. 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 in the next 7 days, including: a. Premature rupture of membranes b. Evidence or suspicion of abruptio placenta c. Signs and/or symptoms of chorio-amnionitis d. Eclampsia or severe pre-eclampsia e. Foetal distress as assessed by the investigator 3. 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 or that could interfere with the trial objectives, conduct or evaluation, including: a. Any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin > ×2 ULN for women in the 3rd trimester of pregnancy (to be confirmed within 24 hours of randomisation). b. Any clinically significant and trial relevant abnormality in the results of the screening physical examination including a gynaecological examination. c. Any clinically significant abnormality on the 12-lead ECG recording at screening (to be assessed up to 24 hours after randomisation). d. The Subject has known positive results from virology tests for HBsAg (not due to vaccination), HBcAb, HCV or HIV 1 or 2. e. The Subject is prone to frequent, severe hypersensitivity to drugs. f. Evidence of recent drug or alcohol abuse. g. The Subject is planning to deliver in another location than the investigational site. 4. The Subject had a BMI mayor or equal to 35 kg/m2 prior to current pregnancy. 5. Use of cervical cerclage or a pessary in the current pregnancy. 6. Treatment with nifedipine, nicardipine or other calcium channel blockers, oral or injectable NSAIDs, betamimetics, nitric oxide donors or intravenously administered magnesium sulphate within 2 weeks of Study Day 1. 7. Administration of atosiban or other OT antagonists or any experimental drug during the current pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of OBE001 with placebo to delay preterm birth by 7 days.;Secondary Objective: To compare the efficacy of OBE001 with placebo to delay preterm birth by 48 hours. To compare the efficacy of OBE001 with placebo to delay birth until gestational week 37. To assess maternal and foetal exposure to OBE001. To evaluate the effect of OBE001 on frequency of uterine contractions. safety objectives: To evaluate the maternal and foetal safety of OBE001. To evaluate the newborn neonatal morbidity up to 28 days post expected term date.;Primary end point(s): Incidence of women delivering within 7 days post first dose (i.e. within 168 hours of first dose).;Timepoint(s) of evaluation of this end point: At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study.	—

Measure

Time frame

Main Objective: To compare the efficacy of OBE001 with placebo to delay preterm birth by 7 days.;Secondary Objective: To compare the efficacy of OBE001 with placebo to delay preterm birth by 48 hours. To compare the efficacy of OBE001 with placebo to delay birth until gestational week 37. To assess maternal and foetal exposure to OBE001. To evaluate the effect of OBE001 on frequency of uterine contractions. safety objectives: To evaluate the maternal and foetal safety of OBE001. To evaluate the newborn neonatal morbidity up to 28 days post expected term date.;Primary end point(s): Incidence of women delivering within 7 days post first dose (i.e. within 168 hours of first dose).;Timepoint(s) of evaluation of this end point: At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study.

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of women delivering within 48 hours post first dose. Incidence of women delivering before gestational age 37 0/7 weeks. The progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose as measured by tocodynamometry. 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), on Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery (time matched with maternal sample). Safety endpoints: Maternal incidence of AEs, TEAEs, clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs from Day 1 until 28 days after birth or term whichever is later. Incidence of foetal distress as determined by clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or AFI from Day 1 to Day 14 or birth, whichever is earlier. Incidence of infants experiencing adverse events assessed by vital signs, temperature, APGAR score, weight and head circumference at birth as well as measures of neonatal morbidity from birth until 28 days after birth or term whichever is later.;Timepoint(s) of evaluation of this end point: At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study. In addition, the DMC will review safety data on at least 2 occasions during the recruitment period and as soon as the first 30 subjects have been randomised.	—

Measure

Time frame

Secondary end point(s): Incidence of women delivering within 48 hours post first dose. Incidence of women delivering before gestational age 37 0/7 weeks. The progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose as measured by tocodynamometry. 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), on Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery (time matched with maternal sample). Safety endpoints: Maternal incidence of AEs, TEAEs, clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs from Day 1 until 28 days after birth or term whichever is later. Incidence of foetal distress as determined by clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or AFI from Day 1 to Day 14 or birth, whichever is earlier. Incidence of infants experiencing adverse events assessed by vital signs, temperature, APGAR score, weight and head circumference at birth as well as measures of neonatal morbidity from birth until 28 days after birth or term whichever is later.;Timepoint(s) of evaluation of this end point: At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study. In addition, the DMC will review safety data on at least 2 occasions during the recruitment period and as soon as the first 30 subjects have been randomised.

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Countries

Belgium, Germany, Poland, Spain, United Kingdom

Contacts

Public ContactClinical Trials Information

ObsEva SA

clinicaltrials@obseva.ch34917088600

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026