Clinical trial NCT02156063: A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Pregnancy Loss
Recurrent Miscarriage
Keywords: Recurrent Pregnancy Loss
Recurrent Miscarriage
Miscarriage
Pregnancy Loss
Repeated Pregnancy Loss
Lead sponsor: Nora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: at Week 20 of gestation
Secondary outcomes:
measure: Live birth
timeFrame: at any time during pregnancy
measure: Clinical pregnancy
timeFrame: at Weeks 6, 8 and 12 of gestation
measure: Spontaneous pregnancy loss
timeFrame: within 24 weeks of gestation
measure: Stillbirth
timeFrame: after 24 weeks of gestation
measure: Subjects with adverse events and serious adverse events
timeFrame: during treatment and within 4 weeks after treatment
measure: Changes in clinical laboratory parameters following study drug exposure
timeFrame: during treatment and within 4 weeks after treatment
Other outcomes:
Locations:
city: Ashington
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Chertsey, Surrey
country: United Kingdom
city: Coventry
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Frimley, Surrey
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Oxford
country: United Kingdom
city: Plymouth
country: United Kingdom
city: South Shields
country: United Kingdom
city: Southamptom
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Sunderland
country: United Kingdom
Study officials:
References:
citation: Eapen A, Joing M, Kwon P, Tong J, Maneta E, De Santo C, Mussai F, Lissauer D, Carter D; RESPONSE study group. Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial. Hum Reprod. 2019 Mar 1;34(3):424-432. doi: 10.1093/humrep/dey393.