BridgeMD
A Phase 3 Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
EU CTIS ID: 2022-502629-16-00
What this study is testing
To evaluate the efficacy of nipocalimab compared with placebo on reducing the risk of fetal anemia with live neonates in pregnant participants at risk for severe HDFN
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female, 18 (or the legal age of consent if above 18 in local regions) to 45 years of age, inclusive, at the time of informed consent.
- Pregnant and an estimated GA (based on ultrasound dating) from Week 13^0/7 and Week 18^6/7 at randomization.
- History of severe HDFN in a prior pregnancy, defined as documented: a. fetal anemia* s result of HDFN* or fetal hydrops** as a result of HDFN, or received ≥1 IUT as a result of HDFN. *defined as fetal hemoglobin level <0.84 MoM (Section 8.2.1.2). Fetal hemoglobin (g/dL) can be calculated using hematocrit (%)/3. **defined as the presence of ≥2 abnormal fluid collections in the fetus as ascites, plural effusions, pericardial effusion, and generalized skin edema (skin thickness >5 mm. OR b. Fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for RhD, Kell, Rhc, RhE, or RhC antigen above the critical levels (anti-Kell ≥4; other ≥16) and evidence of an antigen-positive fetus (When these tests have not been performed as part of regional/local clinical practice, alternative confirmation of HDFN, after consultation with the sponsor, may be considered).
- During the current pregnancy, presence of maternal alloantibody to RhD, Kell, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell ≥4; other ≥16) based on the designated central lab results at screening.
- Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cffDNA performed at the central laboratory.
You likely can't join if
- Currently pregnant with a multiple gestation (twins or more).
- 2.1 Criterion amended per Amendment 6.Evidence of fetal anemia by ultrasound or repeated MCA-PSV ≥1.5 MoM* prior to randomization in the current pregnancy. *In the absence of other evidence of fetal anemia on ultrasound, inability to measure MCA-PSV before GA 14 weeks 0 days, secondary to concerns of safety/accuracy, will not be considered an exclusion.
- 3.2 Criterion amended per Amendment 6. History of severe preeclampsia prior to GA Week 34 or severe FGR (EFW<3rd percentile, based on local fetal growth normative standards) in a previous pregnancy. Note: for countries where the percentiles are not used in clinical practice, local country measures (standard deviations) equivalent to <3rd percentile may be considered after consultation with the sponsor.
- Current uncontrolled hypertension.
- History of myocardial infarction, unstable ischemic heart disease, or stroke.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Brazil
- Argentina
- Australia
- Israel
- Japan
- Saudi Arabia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Brazil; Argentina; Australia; Israel and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.