FNAIT research matters to all of us

Have you experienced a pregnancy impacted by fetal and neonatal alloimmune thrombocytopenia (FNAIT)? If so, it is understandable that you’re concerned about the health of your next baby. Researchers want to help. Consider joining the FREESIA-3 study, a clinical trial for individuals whose pregnancies are at risk from FNAIT.

This website is only for patients in the United States.
Patients outside the United States should go to ClinicalTrials.gov (NCT06533098).

This image depicts models and is for illustrative purposes only.

Who is eligible to participate?

The FREESIA-3 study is enrolling individuals who:

Are 18 to 45 years of age
Are pregnant with an estimated gestational age (based on ultrasound) between Weeks 8^0/7 and 18^6/7
Have a history of at least 1 prior pregnancy with FNAIT

If you are interested in participating, the study doctor or staff will review additional information with you to assess whether you can join the clinical trial.

About FNAIT

FNAIT is a rare immune disorder that affects mothers and their babies during pregnancy.¹
It occurs when the pregnant mother’s immune system tries to get rid of the baby’s platelets. This happens because there are different proteins on the mother’s and baby’s platelets that are not compatible.¹

FNAIT can happen in a woman’s first pregnancy and/or in later pregnancies.¹
It is estimated that FNAIT occurs in between 1/800 to 1/2000 live births.²

About FNAIT

FNAIT can happen in a woman’s first pregnancy and/or in later pregnancies.¹
It is estimated that FNAIT occurs in between 1/800 to 1/2000 live births.²

This image depicts models and is for illustrative purposes only.

How is FNAIT diagnosed before birth?¹

Mother’s blood test: Determines if the mother has antibodies against her baby’s platelets; a positive result indicates the presence of antibodies that could cause the baby’s platelets to break down.
Genetic tests: New development with fetal DNA testing allows us to determine if the baby’s platelet type is not compatible with the mother’s antibodies.

Complications for the baby may include^1,2:

The most common sign of FNAIT is skin discolorations—varying from pinpoint dots to larger areas of discoloration.
The baby may also bruise easily.
Mild symptoms disappear gradually with time and treatment.¹
In more severe cases of FNAIT, babies may experience bleeding in different parts of the body.²
FNAIT can lead to serious health complications for the baby, including bleeding in major organs.¹

About the FREESIA-3 study

The purpose of the FREESIA-3 study is to determine the safety and efficacy of an investigational medication in pregnancies at risk for FNAIT.

You may be able to participate in the FREESIA-3 study if you*:

Are 18 to 45 years of age
Are pregnant with an estimated gestational age (based on ultrasound) between Weeks 8^0/7 and 18^6/7
Have had at least 1 prior pregnancy with FNAIT

*There are more requirements to participate. The study staff can provide you with more information.

You cannot participate in the clinical trial if you:

Are pregnant with more than one baby (twins, triplets, etc)
Have had severe preeclampsia in a previous pregnancy

LINK: PRO Participant Fact Sheet download

Participants will receive either the investigational medication or the standard of care study medication. Neither medication (investigational or standard of care) is approved to treat FNAIT.

Participants will receive their study medication through weekly intravenous (IV) infusions until delivery. Participants and the study doctor/staff will know which study medication is being given. Participants will receive about 23 to 28 IV infusions.
There is a 4 in 5 (80%) chance of receiving the investigational medication. There is a 1 in 5 (20%) chance of receiving the standard of care study medication. Participants who receive the standard of care study medication will receive an additional study medication (a steroid that is taken by mouth).
You and your baby will be closely monitored during the clinical trial and receive the same level of care no matter which group you are assigned to. If there is a change in your or your baby’s health while you are participating, the study doctor will inform you immediately and will discuss your options, as your physical and mental health are of paramount importance.
After giving birth, you will have 3 study clinic visits over the course of 6 months. The first visit will take place before you are discharged from the hospital. Your child will have 6 study visits over the course of 2 years. Visit 1 will occur at birth, and Visit 2 will take place before you are discharged from the hospital.

All participants will receive medication and medical care required by the clinical trial at no cost. Participants will also be reimbursed for travel and expenses required by the clinical trial. You will not be paid for other medical care or medications that are not part of the clinical trial.

The investigational medication has not been approved for use by the FDA. This clinical trial is an important step in a multiphase process required to be completed before the FDA can decide whether the investigational medication is safe and effective for patients.

This image depicts models and is for illustrative purposes only.

This image depicts models and
is for illustrative purposes only.

About the FREESIA-3 study

The purpose of the FREESIA-3 study is to determine the safety and efficacy of an investigational medication in pregnancies at risk for FNAIT.

You may be able to participate in the FREESIA-3 study if you*:

Are 18 to 45 years of age
Are pregnant with an estimated gestational age (based on ultrasound) between Weeks 8^0/7 and 18^6/7
Have had at least 1 prior pregnancy with FNAIT

*There are more requirements to participate. The study staff can provide you with more information.

You cannot participate in the clinical trial if you:

Are pregnant with more than one baby (twins, triplets, etc)
Have had severe preeclampsia in a previous pregnancy

LINK: PRO Participant Fact Sheet download

Participants will receive either the investigational medication or the standard of care study medication. Neither medication (investigational or standard of care) is approved to treat FNAIT.

Participants will receive their study medication through weekly intravenous (IV) infusions until delivery. Participants and the study doctor/staff will know which study medication is being given. Participants will receive about 23 to 28 IV infusions.
There is a 4 in 5 (80%) chance of receiving the investigational medication. There is a 1 in 5 (20%) chance of receiving the standard of care study medication. Participants who receive the standard of care study medication will receive an additional study medication (a steroid that is taken by mouth).
You and your baby will be closely monitored during the clinical trial and receive the same level of care no matter which group you are assigned to. If there is a change in your or your baby’s health while you are participating, the study doctor will inform you immediately and will discuss your options, as your physical and mental health are of paramount importance.
After giving birth, you will have 3 study clinic visits over the course of 6 months. The first visit will take place before you are discharged from the hospital. Your child will have 6 study visits over the course of 2 years. Visit 1 will occur at birth, and Visit 2 will take place before you are discharged from the hospital.

This image depicts models and is for illustrative purposes only.

About clinical trials

Clinical trials, also known as research studies, offer hope for many people and are a chance to help researchers find new and better treatments for others in the future. The information that follows will provide you with a basic understanding of clinical trials. The more you know about clinical trials, the better prepared you will be when deciding if participating in a clinical trial is the right choice for you.

The safety and efficacy of the investigational medications used in clinical trials may differ by age, sex, race, and ethnicity. As a result, the FREESIA-3 study wants to include a diverse group of participants. This will help evaluate the safety and efficacy of the investigational medication in the diverse groups of people who may use it.

FAQ

What is a clinical trial?

A clinical trial, also known as a research study, is a carefully designed scientific evaluation of an investigational medication or treatment that is conducted by doctors and researchers.

Clinical trials are conducted in 4 phases:

Phase 1 clinical trials generally examine the safety of an investigational medication in healthy people.
Phase 2 clinical trials involve the assessment of safety and efficacy, and establishing the appropriate dosing regimens in participants.
Phase 3 clinical trials confirm the efficacy and safety of an investigational medication in participants. The FREESIA-3 study is a Phase 3 clinical trial.
Phase 4 clinical trials are conducted after an investigational medication has been approved to gather additional efficacy and safety information in a real-world setting.

Is it safe to be in a clinical trial?

Research is conducted for many years before an investigational medication advances to a clinical trial. Negative effects are possible. You will be told about all known risks and the potential for unknown risks before you start. During the clinical trial, your study staff will carefully monitor the health and safety of you and your baby. You should report any concerns to your study doctor.

How can I find out about the benefits and risks?

Each clinical trial has a well-documented plan or protocol. Your study team will explain this plan to you, including what to expect and all known benefits and risks of the research. This information will be provided to you in an informed consent form. If you agree to participate in the study, you will be asked to sign the informed consent form and keep a copy for yourself.

Who can participate in the FREESIA-3 study?

The FREESIA-3 study is assessing the safety and efficacy of an investigational medication in pregnancies at risk for FNAIT.

You may be eligible to participate if you are*:

18 to 45 years of age
Are pregnant with an estimated gestational age (based on ultrasound) between Weeks 8^0/7 and 18^6/7
Have a history of at least 1 prior pregnancy with FNAIT

*There are more requirements to participate. The study staff can provide you with more information.

What do I have to do in a clinical trial?

Activities vary from one clinical trial to the next, but most require regular medical examinations. Some clinical trials involve taking either an approved or investigational medication, while others involve a procedure. Your study doctor will discuss these details with you. You may be asked to record information about how you are doing. You also may be asked to return for follow-up visits to evaluate whether the research is producing the intended results.

What does participating in the FREESIA-3 study involve?

The clinical trial will involve weekly visits to the study clinic, which take place over the course of several months. During each visit, the investigational medication or standard of care study medication will be administered by intravenous (IV) infusion. Participants who are receiving the standard of care study medication may receive an additional study medication (a tablet that is taken by mouth). Participants will complete a variety of health exams and tests.

How long is the FREESIA-3 study?

Total participation in this clinical trial will last approximately 3 years.

What is the investigational medication being tested?

The purpose of this clinical trial is to evaluate the safety and efficacy of an investigational medication that is being tested in multiple immune system disorders. The investigational medication is a sterile solution that will be given as an IV infusion during your study visits. IV infusion, or intravenous infusion, involves injecting the investigational medication directly into the bloodstream through a vein.

Can I continue taking my other medications?

Do not discontinue any medications unless you are advised to stop by the study clinic staff or your primary care provider.

Does participation in the FREESIA-3 study cost me anything?

There is no cost to you for participating. All participants will be reimbursed for study-required travel and receive study-required medical care at no cost. Study medication will be provided to you at no cost. You will be responsible for other medical care and medications that are not part of the study.

Will this research help me personally?

The purpose of this clinical trial is to evaluate the safety and efficacy of an investigational medication in pregnancies at risk for FNAIT. A clinical trial may or may not help you personally, but it will provide researchers with valuable information about treating FNAIT in the future.

Can I change my mind about participating in this clinical trial?

Yes. You can withdraw from the clinical trial at any time for any reason. Even if you begin the clinical trial, you can change your mind at any point. The study doctor will discuss your care options with you if you decide to withdraw.

Will my information remain confidential?

Participant information is confidential; however, your provider may be required by law to share your information in certain situations. If information from the clinical trial is published or presented at scientific meetings, your name and other personal information will not be used. The clinical trial sponsor and regulatory agencies also may review the research files and medical records.

I completed the prescreener and was disqualified. Why did I disqualify?

Clinical trials are designed in specific ways, and one or more of the answers that you provided were outside the guidelines for this clinical trial. This does not mean that you will not qualify for different clinical trials.

Link to: Download clinical trials education booklet

Resources

The resources below were included to help connect those affected by FNAIT to understanding communities and reliable information, and to assist in finding support programs and services.

Johnson & Johnson has a relationship with the organizations but is not responsible for the support they provide.

NAME	ABOUT	WEBSITE
Naitbabies	Naitbabies is a small charitable incorporated organisation registered in the UK in 2011 and run by families who have a rare but serious platelet condition called fetal and neonatal alloimmune thrombocytopenia – FNAIT.	naitbabies.org
Fetal Health Foundation	Fetal Health Foundation supports families receiving a fetal syndrome diagnosis, funds lifesaving research, increases fetal syndrome awareness, and shares leading medical information on fetal syndromes.	fetalhealthfoundation.org
FNAIT Companion	If you’re new to FNAIT, this is a good place to start. Learn about the basics of FNAIT — diagnosis, symptoms, treatment — as well as the latest news.	fnaitcompanion.com
Johnson & Johnson	Johnson & Johnson is committed to the well-being of babies and mothers affected by FNAIT. As part of this mission, the company provides information and support along your journey with FNAIT, including one mother’s story as well as background on causes and consequences of FNAIT.	jnj.com/what-its-like-when-your-baby-has-a-rare-blood-disorder

FNAIT Information

TITLE	ORGANIZATION	DESCRIPTION	LINK
Fetal and Neonatal Alloimmune Thrombocytopenia	National Library of Medicine	Learn about FNAIT and its history, epidemiology, and more.	pmc.ncbi.nlm.nih.gov/articles/PMC3593293

Consider joining FREESIA-3 today.

The information you provide will be kept confidential.

This image depicts models and is for illustrative purposes only.

References

Fetal and neonatal alloimmune thrombocytopenia. National Organization for Rare Disorders. Published 2022. Updated July 12, 2022. Accessed August 26, 2024. https://rarediseases.org/rare-diseases/fetal-and-neonatal-alloimmune-thrombocytopenia/
Knowledge on rare diseases and orphan drugs. Orphanet. Updated March 2022. Accessed August 26, 2024. https://www.orpha.net/en/disease/detail/853

FNAIT research matters to all of us

Who is eligible to participate?

About FNAIT

About FNAIT

About the FREESIA-3 study

About the FREESIA-3 study

About clinical trials

FAQ

Resources

FNAIT Information

Consider joining FREESIA-3 today.

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