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PoC Study of OBE022 in Threatened Preterm Labour

NCT03369262 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-06-07

No results posted yet for this study

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

Interventions

DRUG

OBE022

Oral

DRUG

Placebos

Oral

DRUG

Atosiban

I.V.

Sponsors & Collaborators

  • Scope International AG

    collaborator INDUSTRY

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Cytel Inc.

    collaborator INDUSTRY

  • PhinC Development

    collaborator INDUSTRY

  • ObsEva SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2020-07-08
Completion
2022-08-31

Countries

  • Czechia
  • Finland
  • Israel
  • Russia
  • Spain
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369262 on ClinicalTrials.gov