A randomized, 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).

INTERVENTION: Product Code: NT100 Pharmaceutical Form: Solution for injection in pre‐filled syringe Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] Unexplained recurrent pregnancy loss. A distinct disorder from sporadic pregnancy loss and is characterized by the loss of multiple pregnancies ; MedDRA version: 17.0 Level: LLT Classification code 10072314 Term: Pregnancy loss System Organ Class: 100000004868 PRIMARY OUTCOME: Main Objective: • To evaluate the efficacy of subcutaneous NT100 (rhG‐CSF) vs. placebo in pregnant women with a history of unexplained recurrent pregnancy loss; • To evaluate the safety, tolerability, and immunogenicity of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss ; Primary end point(s): The primary outcome measure is the clinical pregnancy rate at Week 20 of gestation. Secondary Objective: Not Applicable Timepoint(s) of evaluation of this end point: 20 weeks SECONDARY OUTCOME: Secondary end point(s): 1. Live birth ; 2. Live birth beyond 34 weeks of gestation ; 3. Clinical pregnancy at Week 6, 8 and 12 of gestation ; 4. Spontaneous pregnancy loss under 24 weeks ; 5. Stillbirth ; 6. Neonatal birth weight ; 7. Infants discharged alive from the hospital following delivery ; 8. Maternal adverse events and serious adverse events during the treatment period and within 4 weeks of the last dose of study drug ; 9. Changes in clinical laboratory parameters following study drug exposure ; 10. Major congenital anomalies ; 11. Diagnosis of pre‐eclampsia, eclampsia, gestational hypertension, or placenta accreta ; 12. Incidence of anti‐drug antibody (ADA) formation ; Timepoint(s) of evaluation of this end point: 1. Live birth ; 2. Live birth beyond 34 weeks of gestation ‐ >34 weeks ; 3. clinical pregnancy rate at Week 6, 8 & 12 of gestation ‐ 6, 8 & 12 weeks ; 4. Spontaneous pregnancy loss ‐ <24 weeks ; 5. Stillbirth ‐ >=24 weeks ; INCLUSION CRITERIA: 1. Pre‐menopausal female 18‐37 years of age at consent, trying to conceive 2. Documented history of unexplained recurrent pregnancy loss, defined as: a. Spontaneous loss of three or more pregnancies prior to 20 completed weeks of gestation b. At least two of the losses must have involved intrauterine clinical pregnancies prior to 20 completed weeks of gestation with normal or unknown fetal karyotype 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range