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

Running, not enrolling · Phase 4

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06444113

Run by

Novartis Pharmaceuticals

People needed

24

Starts

2024-11-25

Expected to finish

2026-10-29

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained before any study assessment is performed.
• Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
• Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
• Participant has delivered term infant (at least 37 weeks gestation).
• 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.

You may not qualify if…

• 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.
• Participant taking medications prohibited by the study protocol at screening.
• Pregnant woman, confirmed by positive serum pregnancy test during screening.
• Female of childbearing potential should use effective contraception as per local label.
• Participant has history of chronic alcohol abuse or drug abuse in the last year.
• 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.
• Participant has history of breast implants, breast augmentation, or breast reduction surgery.
• Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
• Active infections, including mastitis (participant may be included once the infection is resolved).
• Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
• 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.)
• 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.
• Any contraindication as per local label.
• Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.

Where it is running

• UCSF — San Francisco, California, United States
• UC Health Neuroscience Ctr — Aurora, Colorado, United States
• Northwestern Medicine Northwestern University — Winfield, Illinois, United States
• Brigham and Womens Hospital — Brookline, Massachusetts, United States
• Novartis Investigative Site — Munich, Bavaria, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — Foggia, FG, Italy
• Novartis Investigative Site — Bialystok, Poland
• Novartis Investigative Site — Kielce, Poland
• Novartis Investigative Site — Cambridge, United Kingdom
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Oxford, United Kingdom
• Novartis Investigative Site — Salford, United Kingdom

Full record on ClinicalTrials.gov

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