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

RECRUITING Phase 4

Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

NCT06444113 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

Conditions Studied

Interventions

  • DRUG Ofatunumab

Study Locations (20)

Other

  • Novartis Investigative Site — Bochum
  • Novartis Investigative Site — Hamburg
  • Novartis Investigative Site — Tübingen
  • Novartis Investigative Site — Bialystok
  • Novartis Investigative Site — Kielce
  • Novartis Investigative Site — Krakow
  • Novartis Investigative Site — Rzeszów
  • Novartis Investigative Site — Zabrze
  • Caribbean Center for Clinical Research, Inc — Guaynabo
  • Novartis Investigative Site — Cambridge
  • Novartis Investigative Site — London

California

  • UCSF — San Francisco

Colorado

  • UC Health Neuroscience Ctr — Aurora

Illinois

  • Northwestern Medicine Northwestern University — Winfield

Massachusetts

  • Brigham and Womens Hospital — Brookline

North Carolina

  • Duke Neurology — Durham

Bavaria

  • Novartis Investigative Site — Munich

FG

  • Novartis Investigative Site — Foggia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-11-25
Est. Completion 2027-02-23
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06444113

The ClinicalTrials.gov registry entry for NCT06444113 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which Ofatunumab 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: NCT06444113 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Colorado. 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 NCT06444113 about?

NCT06444113 is a clinical study titled "Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis". This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

What is the current status of trial NCT06444113?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-11-25. Estimated completion is 2027-02-23.

What conditions does trial NCT06444113 study?

This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06444113?

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

Who is sponsoring clinical trial NCT06444113?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06444113 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Massachusetts, North Carolina. 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