A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Conditions

• Thrombocytopenia, Neonatal Alloimmune

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Nipocalimab — DRUG
  Nipocalimab will be administered intravenously.
• Intravenous immunoglobulins (IVIG) — DRUG
  IVIG will be administered intravenously.
• Prednisone — DRUG
  Prednisone will be administered orally.

Study Details

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Key Dates

Start date

Feb 10, 2025

Status verified

Jun 2026

Primary completion

Dec 15, 2027

Completion

Dec 5, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Nipocalimab
  Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery.
• Experimental: Arm 2: Intravenous Immunoglobins (IVIG)
  Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.

Primary Outcome Measure

Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L [ Time Frame: Up to 1 Week post birth ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (12)

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