Preterm LaborPhase 2PROLONGNCT03369262
PoC Study of OBE022 in Threatened Preterm Labour
A Phase 2 study testing OBE022 and Atosiban in people with Preterm Labor, run by ObsEva SA at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- OBE022 and Atosiban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 10 Jan 2018to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Israel4 sites
Hilel Yafe Medical Center, Maternal Fetal Unit
Haifa
Rambam Medical Center, Maternal Fetal Unit
Haifa
Meir Medical Center, Obstetrics and Gynecology Department
Kfar Saba
Rabin Medical Center, Fetal-Maternal Medicine, Helen Schneider's Hospital for Women
Petah Tikva
Russia4 sites
Moscow Regional Perinatal Center
Balashikha
Kazan State Medical University
Kazan'
City clinical hospital № 15 named after O. M. Filatov of Healthcare Department of Moscow
Moscow
Perinatal center of the City Clinical Hospital #24
Moscow
Spain4 sites
Hospital La Paz
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Hospital Universitari i Politècnic La Fe
Valencia
Czechia3 sites
Gynekologicko-porodnická klinika Fakultní nemocnice Brno
Brno
Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze
Prague
Ústav pro péči o matku a dítě
Prague
Vietnam2 sites
Hanoi Obstetrics and Gynecology Hospital
Hanoi
My Duc Hospital
Ho Chi Minh City
About this study
Official title: 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.
Read more
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.
- Conditions
- Preterm Labor
- Being tested
- OBE022, Placebos, Atosiban
- Keywords
- preterm labor, preterm birth, premature birth, tocolysis, prostaglandin F2α antagonist, PGF2α, tocolytic
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBE022Drug
Oral
PlacebosDrug
Oral
AtosibanDrug
I.V.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 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. Receives: Drug: OBE022; Drug: Atosiban |
| Placebo | Active comparator | 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. Receives: Drug: Placebos; Drug: Atosiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delivery within 2 days (48 h) from start of IMP administration
Measured: 48 hours
Incidence of delivery within 7 days (168 h) from start of IMP administration
Measured: 168 hours
Incidence of delivery before 37 weeks of GA
Measured: Up to 13 weeks from start of IMP administration
Time to delivery measured from start of IMP administration
Measured: Up to 17 weeks from start of IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start10 Jan 2018
- Primary completion8 Jul 2020
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase 2a, double-blind, parallel group, randomised, placebo controlled, added-on to atosiban.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scope International AG, IQVIA Pty Ltd, Cytel Inc., PhinC Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369262
- Sponsor's protocol ID
- 17-OBE022-003
- Acronym
- PROLONG
- Status last verified
- Jun 2021
- First submitted
- 30 Nov 2017
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PubMed 35947046
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03369262
- Acronym / sponsor ID
- PROLONG / 17-OBE022-003
- Conditions
- Preterm Labor
- Keywords
- preterm labor, preterm birth, premature birth, tocolysis, prostaglandin F2α antagonist, PGF2α, tocolytic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Collaborators
- Scope International AG, IQVIA Pty Ltd, Cytel Inc., PhinC Development
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A phase 2a, double-blind, parallel group, randomised, placebo controlled, added-on to atosiban.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: OBE022, Drug: AtosibanOBE022 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. |
| Placebo | Active comparator | Drug: Placebos, Drug: AtosibanOBE022 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- Use of cervical cerclage in the current pregnancy or a pessary in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBE022Oral | Drug | Active |
| PlacebosOral | Drug | Placebo |
| AtosibanI.V. | Drug | Active, Placebo |
Primary outcome
Incidence of delivery within 2 days (48 h) from start of IMP administration
Time frame: 48 hours
Incidence of delivery within 7 days (168 h) from start of IMP administration
Time frame: 168 hours
Incidence of delivery before 37 weeks of GA
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 35947046Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OBE022 and Atosiban in people with Preterm Labor, run by ObsEva SA at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Israel, Russia, Spain, Czechia, Vietnam and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delivery within 2 days (48 h) from start of IMP administration (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.