Recurrent Miscarriage, Recurrent Pregnancy Loss
Conditions
Keywords
Recurrent Pregnancy Loss, Recurrent Miscarriage, Miscarriage, Pregnancy Loss, Repeated Pregnancy Loss
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.
Interventions
DRUGNT100
DRUGPlacebo
Sponsors
Nora Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy | at Week 20 of gestation | The primary outcome measure is clinical pregnancy at Week 20 of gestation |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed