Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Mary Norton

Description

Summary

The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.

Official Title

A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Keywords

Hemolytic Disease of the Fetus and Newborn M281 HDFN Rhesus Disease Hemolytic disease due to fetomaternal alloimmunization Hemolytic disease of the newborn with Kell alloimmunization Rhesus (Rh) isoimmunization of foetus or newborn Isoimmunization due to other red cell factors ABO isoimmunization of foetus or newborn Haemolytic anaemia due to other unclassified antibodies Isoimmune Isoimmunized Isoimmunization Alloimmune Alloimmunized Alloimmunization Pregnant women Hemolysis

Eligibility

You can join if…

Open to females ages 18 years and up

  • Approximately 15 eligible participants and their offspring will be enrolled
  • Each participant must meet all of the following criteria to be enrolled in the study:
  • Female and ≥18 years of age
  • Pregnant to an estimated gestational age of between 8 up to 14 weeks
  • A previous pregnancy with a gestation that included at least one of the following prior to week 24 gestation:
  • Severe fetal anemia, defined as hemoglobin ≤0.55 multiples of the median (MOM) for gestational age
  • Fetal hydrops with peak systolic velocity MOM ≥1.5
  • Stillbirth with fetal or placental pathology indicative of hemolytic disease of the fetus and newborn (HDFN)
  • Maternal alloantibody titers for anti-D of ≥32, or anti-Kell titers ≥4
  • Free fetal deoxyribonucleic acid consistent with an antigen positive fetus (blood sample taken from mother)
  • MaternaI evidence for Immunity to measles mumps, rubella, and varicella, as documented by serologies performed during Screening. If initial serologies are borderline or negative, they may be repeated at a second lab. Alternatively, vaccination records can be used to support evidence of immunity.
  • Screening immunoglobulin G and albumin levels within the laboratory normal range for gestational age of pregnancy
  • Willing to receive standard of care with intrauterine transfusion if clinically indicated
  • Agree to receive recommended vaccinations per local standard of care for both mother and child throughout the course of the study
  • It is recommended that patients are up-to-date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study patients who received locally-approved (and including emergency use-authorized) Coronavirus Disease 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standard of care for pregnant women receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment

You CAN'T join if...

  • Currently pregnant with multiples (twins or more)
  • Pre-eclampsia In current pregnancy or history of pre-eclampsia in a previous pregnancy
  • Gestational hypertension in the current pregnancy
  • Current unstable hypertension
  • History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy
  • History of genital herpes infection
  • Active Infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior Infection or exposure, but without clinical signs and symptoms of active infection is acceptable)
  • Active infection with tuberculosis as evidenced by positive QuantiFERON-tuberculosis testing
  • Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted)
  • Received live vaccine within 3 months prior to first intravenous infusion of nipocalimab
  • Currently receiving an antibody-based drug or an Fc-fusion protein drug
  • Received plasmapheresis and/or intravenous immunoglobulin during the current pregnancy for treatment of HDFN
  • COVID-19 infection: during the 6 weeks prior to baseline, have had any of: a) confirmed severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) (COVID-19) infection (test positive), or; b) suspected SARS-CoV-2 infection (clinical features without documented test results), or; c) close contact with a person with known or suspected SARS-CoV-2 infection. Exception: may be included with a documented negative result for a validated SARSCoV-2 test: obtained at least 2 weeks after conditions a), b), c) above (timed from resolution of key clinical features if present, example fever, cough, dyspnea) and; with absence of all conditions a), b), c) above during the period between the negative test result and the baseline study visit

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States

Lead Scientist at UCSF

  • Mary Norton
    Professor, Ob/Gyn, Reproductive Sciences. Authored (or co-authored) 205 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03842189
Phase
Phase 2
Study Type
Interventional
Last Updated