PoC Study of OBE022 in Threatened Preterm Labour

NCT03369262 | Unknown Phase 2 DMC

• 1 other identifier: 17-OBE022-003
• Study Type: interventional
• Target: 115
• Locations: 6 countries
• Sites: 18

Brief 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.

Conditions

Preterm Labor

Keywords

preterm labor; preterm birth; premature birth; tocolysis; prostaglandin F2α antagonist; PGF2α; tocolytic

Outcome Measures

Primary Outcomes (4)

• Incidence of delivery within 2 days (48 h) from start of IMP administration

  48 hours

• Incidence of delivery within 7 days (168 h) from start of IMP administration

  168 hours

• Incidence of delivery before 37 weeks of GA

  Up to 13 weeks from start of IMP administration

• Time to delivery measured from start of IMP administration

  Up to 17 weeks from start of IMP administration

Other Outcomes (20)

• Maternal incidence of AEs from Day 1 until 28 days after birth.

  28 days after birth

• Maternal incidence of TEAEs from Day 1 until 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.

  28 days after birth

Study Arms (2)

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.

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.

Drug: Placebos; Drug: Atosiban

Interventions

OBE022 DRUG

Oral

Active

Placebos DRUG

Oral

Placebo

Atosiban DRUG

I.V.

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• positive IGFBP-1 or fœtal Fibronectin test
• cervical length ≤ 25mm

You may not qualify if:

• 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

Sponsors & Collaborators

• ObsEva SA: lead
• Scope International AG: collaborator
• Iqvia Pty Ltd: collaborator
• Cytel Inc.: collaborator
• PhinC Development: collaborator

Study Sites (18)

Gynekologicko-porodnická klinika Fakultní nemocnice Brno

Brno, Czechia

Location

Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze

Prague, Czechia

Location

Ústav pro péči o matku a dítě

Prague, Czechia

Location

Helsinki Universisty Hospital

Helsinki, Finland

Location

Hilel Yafe Medical Center, Maternal Fetal Unit

Haifa, Israel

Location

Rambam Medical Center, Maternal Fetal Unit

Haifa, Israel

Location

Meir Medical Center, Obstetrics and Gynecology Department

Kfar Saba, Israel

Location

Rabin Medical Center, Fetal-Maternal Medicine, Helen Schneider's Hospital for Women

Petah Tikva, Israel

Location

Moscow Regional Perinatal Center

Balashikha, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

City clinical hospital № 15 named after O. M. Filatov of Healthcare Department of Moscow

Moscow, Russia

Location

Perinatal center of the City Clinical Hospital #24

Moscow, Russia

Location

Hospital La Paz

Madrid, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Hanoi Obstetrics and Gynecology Hospital

Hanoi, Vietnam

Location

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

obe022; atosiban

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matching placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A phase 2a, double-blind, parallel group, randomised, placebo controlled, added-on to atosiban.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 11, 2017
• Study Start: January 10, 2018
• Primary Completion: July 8, 2020
• Study Completion: August 1, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); ES (4); IL (4); RU (4); VN (2); FI (1)