PoC Study of OBE022 in Threatened Preterm Labour (PROLONG)

June 4, 2021 updated by: ObsEva SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Gynekologicko-porodnická klinika Fakultní nemocnice Brno
      • Praha, Czechia
        • Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze
      • Praha, Czechia
        • Ustav pro peci o matku a dite
  • Finland
      • Helsinki, Finland
        • Helsinki Universisty Hospital
  • Israel
      • Haifa, Israel
        • Hilel Yafe Medical Center, Maternal Fetal Unit
      • Haifa, Israel
        • Rambam Medical Center, Maternal Fetal Unit
      • Kfar Saba, Israel
        • Meir Medical Center, Obstetrics and Gynecology Department
      • Petah tikva, Israel
        • Rabin Medical Center, Fetal-Maternal Medicine, Helen Schneider's Hospital for Women
  • Russian Federation
      • Balašicha, Russian Federation
        • Moscow Regional Perinatal Center
      • Kazan, Russian Federation
        • Kazan State Medical University
      • Moscow, Russian Federation
        • City clinical hospital № 15 named after O. M. Filatov of Healthcare Department of Moscow
      • Moscow, Russian Federation
        • Perinatal center of the City Clinical Hospital #24
  • Spain
      • Madrid, Spain
        • Hospital La Paz
      • Murcia, Spain
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Santiago De Compostela, Spain
        • Hospital Clínico Universitario de Santiago
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
  • Vietnam
      • Hanoi, Vietnam
        • Hanoi Obstetrics and Gynecology Hospital
      • Ho Chi Minh City, Vietnam
        • My Duc Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: OBE022
Oral
Drug: Atosiban
I.V.
Active Comparator: 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.
Drug: Atosiban
I.V.
Drug: Placebos
Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of delivery within 2 days (48 h) from start of IMP administration
Time Frame: 48 hours
48 hours
Incidence of delivery within 7 days (168 h) from start of IMP administration
Time Frame: 168 hours
168 hours
Incidence of delivery before 37 weeks of GA
Time Frame: Up to 13 weeks from start of IMP administration
Up to 13 weeks from start of IMP administration
Time to delivery measured from start of IMP administration
Time Frame: Up to 17 weeks from start of IMP administration
Up to 17 weeks from start of IMP administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal incidence of AEs from Day 1 until 28 days after birth.
Time Frame: 28 days after birth
28 days after birth
Maternal incidence of TEAEs from Day 1 until 28 days after birth.
Time Frame: 28 days after birth
28 days after birth
Maternal incidence of clinically significant changes in laboratory safety tests, from Day 1 until 28 days after birth.
Time Frame: 28 days after birth
28 days after birth
Maternal incidence of clinically significant changes in vital signs, from Day 1 until 28 days after birth.
Time Frame: 28 days after birth
28 days after birth
Incidence of AEs indicating fœtal distress such as growth retardation and/or changes in fœtal heart rate monitoring and/or amniotic fluid index (AFI) from Day 1 to Day 7 and Day 14 (or earlier if birth).
Time Frame: Up to 14 days after start of IMP administration
Up to 14 days after start of IMP administration
In Part A only: Incidence of fœtal adverse events in relation with the cardiovascular function assessed by Doppler ultrasound on Day 1 to 3 and Day 7 from IMP start.
Time Frame: Up to 7 days after start of IMP administration
Up to 7 days after start of IMP administration
Incidence of infants experiencing adverse events from birth until 28 days after birth.
Time Frame: Up to 28 days after birth
Up to 28 days after birth
Incidence of infants experiencing clinical significant changes in vital signs from birth until 28 days after birth.
Time Frame: Up to 28 days after birth
Up to 28 days after birth
Apgar score.
Time Frame: At birth, at 1 minute and 5 minute
The score is a rapid method for assessing a neonate immediately after birth. Elements of the Apgar score include color, heart rate, reflexes, muscle tone, and respiration, each weighted evenly and assigned a value of 0, 1, or 2. The components are then added together to give a total score (0 to 10) that is recorded at 1 and 5 minutes after birth.
At birth, at 1 minute and 5 minute
Weight.
Time Frame: At birth and 28 days after birth.
At birth and 28 days after birth.
Head circumference.
Time Frame: At birth and 28 days after birth.
At birth and 28 days after birth.
Incidence of infants experiencing prematurity-related events
Time Frame: At birth.
At birth.
Incidence of duration of hospitalization and or re-admission to hospital.
Time Frame: Up to 28 days after birth.
Up to 28 days after birth.
Incidence of infants with one or more Ages and Stages Questionnaire® domain score(s) below the cut-off score at 6 months, 12 months and 24 months of age, adjusted for gestational age at birth.
Time Frame: Up to 24 months
The Ages and Stages Questionnaire (ASQ) is a parent-completed questionnaire designed to be used as a general developmental screening tool. The ASQ-3 covers five areas of child development that includes: personal social, gross motor, fine motor, problem solving, and communication. Parents complete the questionnaire independent of professionals, indicating for each item "yes" if child performs the item, "sometimes" indicating an occasional or emerging skill, or "not yet" indicating that the child does not yet perform the behavior
Up to 24 months
Plasma concentration of OBE022/OBE002 at Day 1, Day 2, Day 3 and Day 7.
Time Frame: Up to 7 days after start of IMP administration
Up to 7 days after start of IMP administration
Pharmacokinetic parameters of OBE022/OBE002 at Day 7
Time Frame: Day 7
Area under the curve (AUC)
Day 7
Pharmacokinetic parameters of OBE022/OBE002 at Day 7
Time Frame: Day 7
Maximal concentration (Cmax)
Day 7
Pharmacokinetic parameters of OBE022/OBE002 at Day 7
Time Frame: Day 7
Half-life.
Day 7
Fœtal (cord blood)-maternal OBE002 concentration ratio at the time of delivery for patients who received IMP treatment within the previous 24 h.
Time Frame: Day of delivery
Day of delivery
Changes in uterine contractions as assessed by electrohysterography, tocodynamometry or abdominal palpation at each hour during the first 6 hours after IMP start.
Time Frame: Up to 6 hours after IMP start.
Up to 6 hours after IMP start.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ObsEva SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd
Cytel Inc.
Scope International AG
PhinC Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-OBE022-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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