Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

NCT06312644 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

Interventions

  • DRUG Ultomiris

Study Locations (8)

Other

  • Research Site — Paris
  • Research Site — Rome
  • Research Site — Seoul
  • Research Site — Seoul
  • Research Site — London

Massachusetts

  • Research Site — Boston

Victoria

  • Research Site — Melbourne

Norte-Westfalia

  • Research Site — Essen

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-12-16
Est. Completion 2034-07-11

Sponsor

Alexion Pharmaceuticals

109 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06312644

The ClinicalTrials.gov registry entry for NCT06312644 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Ultomiris is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06312644 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Other, Massachusetts, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06312644 about?

NCT06312644 is a clinical study titled "Study of Ultomiris® (Ravulizumab) Safety in Pregnancy". The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1...

What is the current status of trial NCT06312644?

This trial is currently recruiting. The enrollment target is 75 participants. The study started on 2024-12-16. Estimated completion is 2034-07-11.

What conditions does trial NCT06312644 study?

This clinical trial studies the following conditions: Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Generalized Myasthenia Gravis (gMG), Neuromyelitis Optica Spectrum Disorder (NMOSD), Ultomiris-exposed Pregnant/ Postpartum. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06312644?

The interventions under investigation include: Ultomiris (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06312644?

This trial is sponsored by Alexion Pharmaceuticals, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06312644 being conducted?

This trial has 8 study locations across Massachusetts, Victoria, Norte-Westfalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial