Measuring Ofatumumab Levels in Breast Milk of Lactating Women with Multiple Sclerosis

A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab

This study is testing how much of the multiple sclerosis medication ofatumumab is found in the breast milk of new mothers who are starting or resuming treatment after giving birth.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Female
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: ofatumumab
• Locations: 11 sites (San Francisco, California and 10 other locations)
• Trial ID: NCT06444113 on ClinicalTrials.gov

What this trial studies

This study evaluates the concentration of ofatumumab, a medication for relapsing forms of multiple sclerosis, in the breast milk of lactating women. It involves breastfeeding mothers who plan to start or resume ofatumumab treatment between 2 to 24 weeks postpartum. Participants will provide breast milk and blood samples over a period of up to 12 weeks, followed by a safety follow-up lasting about 9 months to monitor the health of both mothers and their infants.

Who should consider this trial

Good fit: Ideal candidates are postpartum women with relapsing forms of multiple sclerosis who are planning to exclusively breastfeed and initiate or re-initiate ofatumumab treatment.

Not a fit: Patients who are not postpartum, do not plan to breastfeed, or are not initiating ofatumumab treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide crucial information on the safety and levels of ofatumumab in breast milk, helping to inform treatment decisions for lactating women with multiple sclerosis.

How similar studies have performed: While studies on drug excretion in breast milk are common, this specific investigation into ofatumumab's levels in lactating women with MS is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

San Francisco, California and 10 other locations

• UCSF — San Francisco, California, United States (Recruiting)
• UC Health Neuroscience Ctr — Aurora, Colorado, United States (Recruiting)
• Northwestern Medicine Northwestern University — Winfield, Illinois, United States (Recruiting)
• Brigham and Womens Hospital — Brookline, Massachusetts, United States (Recruiting)
• Duke Neurology — Durham, North Carolina, United States (Recruiting)
• Novartis Investigative Site — Bochum, Germany (Recruiting)
• Novartis Investigative Site — Muenchen, Germany (Recruiting)
• Novartis Investigative Site — Tuebingen, Germany (Recruiting)
• Caribbean Center for Clinical Research, Inc — Guaynabo, Puerto Rico (Recruiting)
• Novartis Investigative Site — London, United Kingdom (Recruiting)
• Novartis Investigative Site — Salford, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Multiple Sclerosis; Lactating women,; multiple sclerosis; ofatumumab; milk concentration; breastfed infant