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MS drug levels in breast milk under study for nursing moms

NCT ID NCT06444113

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent must be obtained before any study assessment is performed. 2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent. 3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples. 4. Participant has delivered term infant (at least 37 weeks gestation). 5. Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study. Exclusion Criteria: 1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. 2. Participant taking medications prohibited by the study protocol at screening. 3. Pregnant woman, confirmed by positive serum pregnancy test during screening. 4. Female of childbearing potential should use effective contraception as per local label. 5. Participant has history of chronic alcohol abuse or drug abuse in the last year. 6. Participant has any medical, obstetrical, psychiatric or other medical condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or confound the study assessment. 7. Participant has history of breast implants, breast augmentation, or breast reduction surgery. 8. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy. 9. Active infections, including mastitis (participant may be included once the infection is resolved). 10. Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state. 11. Participant with active hepatitis B disease prior to the initiation or re-initiation of ofatumumab. (Participant with positive hepatitis B serology should consult a liver disease medical standards to prevent hepatitis B reactivation.) 12. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 13. Any contraindication as per local label. 14. Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.

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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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