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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Double Blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

Conditions
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Recurrent Pregnancy Loss, Recurrent Miscarriage

Intervention / Treatment
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* Drug: NT100
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal female 18-37 years of age at consent, trying to conceive Documented history of unexplained recurrent pregnancy loss Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site Body mass index (BMI) of 19-35 kg/m2 at consent Exclusion Criteria: Greater than 5 weeks of gestation when presenting for randomisation. Known karyotype abnormalities in either the participant or her current male partner Uncorrected clinically significant intrauterine abnormalities Abnormal vaginal bleeding of unknown cause Current diagnosis of infertility in either the participant or her current male partner Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery. Any uncontrolled clinically significant medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT100<br>NT100 Dose 1 | Drug: NT100<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy | The primary outcome measure is clinical pregnancy at Week 20 of gestation | at Week 20 of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Pregnancy Loss, Recurrent Miscarriage, Miscarriage, Pregnancy Loss, Repeated Pregnancy Loss