Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Feb 2025 → ongoing

Decision date (initial)

2024-12-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenomic

To assess the efficacy of study intervention on the risk of severe FNAIT

Conditions and MedDRA coding

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Aged 18 (or the legal age of consent if above 18 years in local region) to 45 years at the time of informed consent.
2. Pregnant and an estimated GA from Week 13^0/7 to 18^6/7 at Visit 1. (Note: Screening may start at GA Week 8).
3. Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or anti-HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood.
4. Health status considered stable by the investigator on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening.

Exclusion criteria 4

1. Currently pregnant with multiple gestations (twins or more).
2. History of severe preeclampsia in a previous pregnancy.
3. History of severe FGR (birth weight <3rd percentile for GA) in a previous pregnancy.
4. History of myocardial infarction, unstable ischemic heart disease, or stroke.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Adverse outcome of death or adjudicated severe bleeding in utero, and up to the first week post birth, or platelet count at birth <30×10^9/L in a fetus/neonate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 10

Locations

4 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications