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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Miscarriage; Recurrent Pregnancy Loss
• Intervention / Treatment: Drug: Placebo; Drug: NT100

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Ashington, United Kingdom
  • Birmingham, United Kingdom
  • Chertsey, Surrey, United Kingdom
  • Coventry, United Kingdom
  • Edinburgh, United Kingdom
  • Frimley, Surrey, United Kingdom
  • Leeds, United Kingdom
  • Liverpool, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Middlesbrough, United Kingdom
  • Newcastle upon Tyne, United Kingdom
  • Nottingham, United Kingdom
  • Oxford, United Kingdom
  • Plymouth, United Kingdom
  • South Shields, United Kingdom
  • Southamptom, United Kingdom
  • Stoke-on-Trent, United Kingdom
  • Sunderland, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: NT100; NT100 Dose 1	Drug: NT100

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Nora Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Miscarriage; Recurrent Pregnancy Loss; Recurrent Miscarriage; Pregnancy Loss; Repeated Pregnancy Loss
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Death; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Fetal Death
• Other Study ID Numbers: NT-05