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NCT06444113 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
20
Study locations

NCT06444113 is a Phase 4 study of Multiple Sclerosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT06444113, a Phase 4 study of Multiple Sclerosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
20
Study locations

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

1,375 total trials

What the Registry Record Tells You About NCT06444113

The ClinicalTrials.gov registry entry for NCT06444113 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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.

NCT06444113 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Colorado.

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.

What interventions are being tested in trial NCT06444113?

The interventions under investigation include: Ofatunumab (DRUG).

Who is sponsoring clinical trial NCT06444113?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.