A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

Phase 2

• Conditions: Recurrent Miscarriage; Recurrent Pregnancy Loss
• Interventions: Drug: NT100; Drug: Placebo

• Registration Number: NCT02156063
• Lead Sponsor: Nora Therapeutics, Inc.

Brief Summary

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.

Detailed Description

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo. Participants will be screened for eligibility, and will begin attempts at spontaneous conception. Following randomization and initiation of study drug treatment, participants will visit the study site at specified intervals throughout the study for assessments and blood work.

All participants will be monitored for adverse events. All participants who have received at least one dose of study drug will be followed for safety for a minimum of 4 weeks following the last dose of study drug. After delivery, pregnancy outcome information will be obtained.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-15
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Pre-menopausal female 18-37 years of age at consent, trying to conceive
2. Documented history of unexplained recurrent pregnancy loss
3. Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
4. Body mass index (BMI) of 19-35 kg/m2 at consent

Exclusion Criteria

1. Greater than 5 weeks of gestation when presenting for randomisation.
2. Known karyotype abnormalities in either the participant or her current male partner
3. Uncorrected clinically significant intrauterine abnormalities
4. Abnormal vaginal bleeding of unknown cause
5. Current diagnosis of infertility in either the participant or her current male partner
6. Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
7. Any uncontrolled clinically significant medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NT100	NT100	NT100 Dose 1
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy	at Week 20 of gestation	The primary outcome measure is clinical pregnancy at Week 20 of gestation

Secondary Outcome Measures

Name	Time	Method
Live birth	at any time during pregnancy
Clinical pregnancy	at Weeks 6, 8 and 12 of gestation
Spontaneous pregnancy loss	within 24 weeks of gestation
Stillbirth	after 24 weeks of gestation
Subjects with adverse events and serious adverse events	during treatment and within 4 weeks after treatment
Changes in clinical laboratory parameters following study drug exposure	during treatment and within 4 weeks after treatment