MS drug levels in breast milk under study for nursing moms

NCT ID NCT06444113

Ongoing Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study looks at how much of the multiple sclerosis drug ofatumumab gets into breast milk. About 24 women with relapsing MS who are breastfeeding and starting or restarting ofatumumab will provide milk samples. The goal is to measure drug concentrations, which may help guide future breastfeeding recommendations.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ofatumumab
What this could lead to: If successful, this study could help doctors give better advice to women with MS who want to breastfeed while on ofatumumab.
What could go wrong: This is a small, observational study (24 participants) that only measures drug levels in milk, not safety or long-term effects on babies. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MULTIPLE SCLEROSIS

Contacts and locations

Locations

Brigham and Womens Hospital

Brookline, Massachusetts, 02445, United States
Northwestern Medicine Northwestern University

Winfield, Illinois, 60190, United States
Novartis Investigative Site

Munich, Bavaria, 81377, Germany
Novartis Investigative Site

Bochum, 44791, Germany
Novartis Investigative Site

Hamburg, 22179, Germany
Novartis Investigative Site

Tübingen, 72076, Germany
Novartis Investigative Site

Foggia, FG, 71122, Italy
Novartis Investigative Site

Bialystok, 15 276, Poland
Novartis Investigative Site

Kielce, 25-726, Poland
Novartis Investigative Site

Cambridge, CB2 0QQ, United Kingdom
Novartis Investigative Site

London, NW1 2BU, United Kingdom
Novartis Investigative Site

Oxford, OX3 9DU, United Kingdom
Novartis Investigative Site

Salford, M6 8HD, United Kingdom
UC Health Neuroscience Ctr

Aurora, Colorado, 80045, United States
UCSF

San Francisco, California, 94115, United States

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