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.
Brief Title
A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Recurrent Pregnancy Loss
Recurrent Miscarriage
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
Female
Gender Based
false
Keywords
Recurrent Pregnancy Loss
Recurrent Miscarriage
Miscarriage
Pregnancy Loss
Repeated Pregnancy Loss
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
37 Years
Minimum Age
18 Years
NCT Id
NCT02156063
Org Class
Industry
Org Full Name
Nora Therapeutics, Inc.
Org Study Id
NT-05
Overall Status
Unknown status
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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)
Primary Outcomes
Outcome Description
The primary outcome measure is clinical pregnancy at Week 20 of gestation
Outcome Measure
Clinical Pregnancy
Outcome Time Frame
at Week 20 of gestation
Secondary Outcomes
Outcome Time Frame
at any time during pregnancy
Outcome Measure
Live birth
Outcome Time Frame
at Weeks 6, 8 and 12 of gestation
Outcome Measure
Clinical pregnancy
Outcome Time Frame
within 24 weeks of gestation
Outcome Measure
Spontaneous pregnancy loss
Outcome Time Frame
after 24 weeks of gestation
Outcome Measure
Stillbirth
Outcome Time Frame
during treatment and within 4 weeks after treatment
Outcome Measure
Subjects with adverse events and serious adverse events
Outcome Time Frame
during treatment and within 4 weeks after treatment
Outcome Measure
Changes in clinical laboratory parameters following study drug exposure
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
37
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Zev Williams
Investigator Email
Investigator Phone