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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
Pivotal 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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52 and 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52 and 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~520
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,783 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
773 Previous Clinical Trials
3,980,810 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant and between 13 to 16 weeks along.I do not have a severe or opportunistic infection.I have had a heart attack, unstable heart disease, or stroke.I am on immunosuppressive drugs for an inflammatory or autoimmune disease.My high blood pressure is not under control.I have or suspect I have an immune system disorder, or it runs in my family.I am currently taking steroids or other drugs that weaken my immune system.I am receiving or planning to receive certain treatments during my current pregnancy.My blood has antibodies against specific Rh antigens above critical levels.My baby's DNA test shows a match to my antibodies.I have had cancer or am currently diagnosed with cancer within the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Nipocalimab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.