Pregnancy RelatedPETUNIANCT07915232
A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab
An observational study of Pregnancy Related and Pregnancy, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this study is to find out how often: Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related, Pregnancy, Pregnancy High-risk
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Apr 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Who may be able to join
- Documented exposure to least one dose of nipocalimab any time immediately before ( 1 week [7 days ] before estimated date of conception) or during pregnancy in the post-marketing setting
Who cannot join
- Reports in which the pregnant person discontinued nipocalimab 1 week (7 days) before the estimated date of conception
- Indirect case reports (reported by someone other than the patient or the health care provider [HCP]) for which the reporter refuses to provide follow-up information, and the participants or HCP cannot be identified based on the information provided
- Case lacking reporter contact details
- Cases where only the father/male partner is exposed to nipocalimab during partner's pregnancy
- Cases occurring in an interventional setting (that is, clinical trials)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nipocalimab Pregnancy Enhanced Tracking With Neonatal and Infant Assessment
The purpose of this study is to find out how often:
- Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy.
- Serious infections occur in newborns and infants born to participants who took nipocalimab just before or during pregnancy.
- Babies are born with major birth defects (not related to chromosomes) in pregnancies where nipocalimab was taken just before or during pregnancy.
- Conditions
- Pregnancy Related, Pregnancy, Pregnancy High-risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Exposed to Nipocalimab Immediately Before or During Pregnancy | Participants with documented exposure to at least one dose of nipocalimab any time immediately before (within 1 week [7 days] before estimated date of conception) or during pregnancy in the post-marketing setting. No drug will be administered as a part of this study. Participants received nipocalimab as per their routine clinical practice settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Fetal Growth Restriction
A fetus with an estimated fetal weight less than the 10th percentile for gestational age based upon a population reference or standard.
Measured: During pregnancy (Up to Week 42)
Prevalence of Small for Gestational Age
A newborn with a birthweight less than the 10th percentile for gestational age based upon a population reference or standard.
Measured: At birth
Prevalence of Hypertensive Disorders of Pregnancy
Hypertensive disorder of pregnancy (that is, preeclampsia, gestational hypertension, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, or eclampsia).
Measured: From 20 weeks gestation through 6 weeks postpartum
Prevalence of Placental Abruption
A condition in which the placenta has begun to separate from the uterus before the fetus is born.
Measured: During pregnancy (Up to Week 42)
Prevalence of Serious Infections in Neonates
Infections resulting in a hospitalization that occur within the first 27 days of life (0-27 days).
Measured: Birth to 27 days
Prevalence of Serious Infections in Infants
Infections resulting in a hospitalization that occur between 28 and 365 days of life.
Measured: 28 days to 365 days after birth
Prevalence of Non-chromosomal Major Congenital Malformations
Congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact, excluding those that are chromosomal or Mendelian-inherited anomalies.
Measured: During pregnancy (up to Week 42) and up to 1 year after birth
Secondary outcomes (8)
Prevalence of Live Birth
Delivery of a live newborn.
Measured: At Delivery
Prevalence of Spontaneous Abortion
Clinically detected pregnancy loss before 20 completed weeks of gestation that occurs without medical or surgical intervention to terminate the pregnancy.
Measured: Prior to 20 weeks gestation
Prevalence of Stillbirth
Fetus born dead at >= 20 weeks gestation or weighing >= 350 grams. Fetal death occurring > 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring > 28 weeks is considered a late fetal loss. If gestational age is unknown, stillbirth refers to a fetus weighing >= 350 grams.
Measured: At or after 20 completed weeks of gestation
Prevalence of Preterm Birth
Delivery of a viable infant before 37 completed weeks of gestation.
Measured: Prior to 37 completed weeks of gestation
Prevalence of Intrapartum Hemorrhage
Maternal complication characterized by significant blood loss occurring during pregnancy.
Measured: During pregnancy (Up to 42 weeks)
Prevalence of Postpartum Hemorrhage
Maternal complication characterized by significant blood loss occurring after pregnancy.
Measured: At Birth and after 12 weeks delivery
Prevalence of Neonatal Death
Death that occurs within the first 27 days of life (0-27 days).
Measured: Birth to 27 days
Prevalence of Infant Death
Death that occurs between 28 and 365 days of life.
Measured: 28 days to 365 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2036 (estimated)
- Study completion30 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915232
- Sponsor's protocol ID
- 80202135MYG4003
- Other IDs
- 80202135MYG4003
- Acronym
- PETUNIA
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nipocalimab Pregnancy Enhanced Tracking With Neonatal and Infant Assessment
- ClinicalTrials.gov ID
- NCT07915232
- Acronym / sponsor ID
- PETUNIA / 80202135MYG4003
- Conditions
- Pregnancy Related, Pregnancy, Pregnancy High-risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2036 (estimated)
- Study completion
- 30 Apr 2036 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out how often:
- Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy.
- Serious infections occur in newborns and infants born to participants who took nipocalimab just before or during pregnancy.
- Babies are born with major birth defects (not related to chromosomes) in pregnancies where nipocalimab was taken just before or during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Exposed to Nipocalimab Immediately Before or During Pregnancy | – | –Participants with documented exposure to at least one dose of nipocalimab any time immediately before (within 1 week [7 days] before estimated date of conception) or during pregnancy in the post-marketing setting. No drug will be administered as a part of this study. Participants received nipocalimab as per their routine clinical practice settings. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Key inclusion criteria (1 listed)
- Documented exposure to least one dose of nipocalimab any time immediately before ( 1 week [7 days ] before estimated date of conception) or during pregnancy in the post-marketing setting
Key exclusion criteria (5 listed)
- Reports in which the pregnant person discontinued nipocalimab 1 week (7 days) before the estimated date of conception
- Indirect case reports (reported by someone other than the patient or the health care provider [HCP]) for which the reporter refuses to provide follow-up information, and the participants or HCP cannot be identified based on the information provided
- Case lacking reporter contact details
- Cases where only the father/male partner is exposed to nipocalimab during partner's pregnancy
- Cases occurring in an interventional setting (that is, clinical trials)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Fetal Growth Restriction
Time frame: During pregnancy (Up to Week 42)
A fetus with an estimated fetal weight less than the 10th percentile for gestational age based upon a population reference or standard.
Prevalence of Small for Gestational Age
Time frame: At birth
A newborn with a birthweight less than the 10th percentile for gestational age based upon a population reference or standard.
Prevalence of Hypertensive Disorders of Pregnancy
Time frame: From 20 weeks gestation through 6 weeks postpartum
Hypertensive disorder of pregnancy (that is, preeclampsia, gestational hypertension, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, or eclampsia).
Prevalence of Placental Abruption
Time frame: During pregnancy (Up to Week 42)
A condition in which the placenta has begun to separate from the uterus before the fetus is born.
Prevalence of Serious Infections in Neonates
Time frame: Birth to 27 days
Infections resulting in a hospitalization that occur within the first 27 days of life (0-27 days).
Prevalence of Serious Infections in Infants
Time frame: 28 days to 365 days after birth
Infections resulting in a hospitalization that occur between 28 and 365 days of life.
Prevalence of Non-chromosomal Major Congenital Malformations
Time frame: During pregnancy (up to Week 42) and up to 1 year after birth
Congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact, excluding those that are chromosomal or Mendelian-inherited anomalies.
8 secondary outcomes
Prevalence of Live Birth
Time frame: At Delivery
Prevalence of Spontaneous Abortion
Time frame: Prior to 20 weeks gestation
Prevalence of Stillbirth
Time frame: At or after 20 completed weeks of gestation
Prevalence of Preterm Birth
Time frame: Prior to 37 completed weeks of gestation
Prevalence of Intrapartum Hemorrhage
Time frame: During pregnancy (Up to 42 weeks)
Prevalence of Postpartum Hemorrhage
Time frame: At Birth and after 12 weeks delivery
Prevalence of Neonatal Death
Time frame: Birth to 27 days
Prevalence of Infant Death
Time frame: 28 days to 365 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy, run by Janssen Research & Development, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Fetal Growth Restriction (time frame: During pregnancy (Up to Week 42)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.