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Monoclonal Antibodies

Nipocalimab for Hemolytic Disease of the Fetus and Newborn (AZALEA Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52 and 104

Awards & highlights

AZALEA Trial Summary

This trial will study if a drug can reduce the risk of anemia in unborn babies with certain conditions.

Who is the study for?

This trial is for pregnant women between weeks 13 and 16^6/7 of gestation, who have had severe HDFN in a past pregnancy or have certain high-risk antibodies. They must be generally healthy with specific normal lab values and no multiple pregnancies, immunodeficiencies, malignancies within the last three years (except some skin cancers), uncontrolled hypertension, or recent use of certain immune therapies.Check my eligibility

What is being tested?

The study tests nipocalimab's ability to reduce fetal anemia risk due to HDFN compared to a placebo. Participants will receive either nipocalimab or placebo while researchers monitor the health outcomes of their babies at birth.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to altering the immune system such as allergic responses, potential infections due to immunosuppression, and possible infusion-related reactions.

AZALEA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52 and 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52 and 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 and 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death

Secondary outcome measures

Absolute Weight of Liveborn Neonates or Infants

Bayley Scales of Infant Development and Toddler Development

Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score

+36 more

AZALEA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NipocalimabExperimental Treatment1 Intervention

Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo IV qw from randomization through GA Week 35.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,572 Total Patients Enrolled

1 Trials studying Hemolytic Disease of the Fetus and Newborn

14 Patients Enrolled for Hemolytic Disease of the Fetus and Newborn

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,158 Total Patients Enrolled

1 Trials studying Hemolytic Disease of the Fetus and Newborn

14 Patients Enrolled for Hemolytic Disease of the Fetus and Newborn

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05912517 — Phase 3

Hemolytic Disease of the Fetus and Newborn Research Study Groups: Nipocalimab, Placebo

Hemolytic Disease of the Fetus and Newborn Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT05912517 — Phase 3

Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912517 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Nipocalimab deleterious to patient health?

"The clinical data surrounding nipocalimab's safety is quite robust, thus earning it a score of 3."

Answered by AI

To which demographic is this research open?

"Candidates who wish to partake in this medical experiment must have a diagnosis of hemolytic disease of the fetus and newborn, as well as be between 18 and 45 years old. The research team is seeking approximately 120 participants overall."

Answered by AI

Are there any openings available for this research study?

"In accordance with the data hosted on clinicaltrials.gov, this medical trial is not currently seeking participants. It was initially listed on November 13th of 2023 and most recently revised June 28th of the same year. Nevertheless, there are 40 other studies actively recruiting patients at this time."

Answered by AI

Is this experiment accommodating individuals older than 85 years?

"This clinical trial has established that eligible participants must be aged 18 to 45. There are 7 trials specifically for minors and 36 studies dedicated to adults over the age of 65."

Answered by AI

In which geographical areas is this experiment accessible?

"This study is recruiting patients from 12 different sites, such as Columbia University Medical Center in New york City and the University of North carolina - School of Medicine based in Chapel Hill. Moreover, there are an additional 10 clinical trial centres across America where participants can be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

2023. "A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05912517.