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

Last updated: May 9, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

Ofatunumab

Clinical Study ID

NCT06444113
COMB157G2410
2023-505283-11-00
  • Ages 18-100
  • Female

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.

Eligibility Criteria

Inclusion

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 atthe time of providing consent.

  3. Participant must be postpartum at the time of enrollment, plan to be exclusivelybreastfeeding 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-initiatedtreatment with ofatumumab between 2 to 24 weeks postpartum. The decision to betreated with ofatumumab and to breastfeed is made in accordance with the treatingphysician and must be completely independent of the decision to participate in thisstudy.

Exclusion

Exclusion Criteria:

  1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30days 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 locallabel.

  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 conditionthat, in the opinion of the Investigator, can jeopardize or would compromise thesubject's ability to participate in this study or confound the study assessment.

  7. Participant has history of breast implants, breast augmentation, or breast reductionsurgery.

  8. Participant has received anti-CD20 agents during the second and third trimesters ofpregnancy.

  9. Active infections, including mastitis (participant may be included once theinfection is resolved).

  10. Prior or current history of primary or secondary immunodeficiency, or participant inan otherwise severely immunocompromised state.

  11. Participant with active hepatitis B disease prior to the initiation or re-initiationof ofatumumab. (Participant with positive hepatitis B serology should consult aliver disease medical standards to prevent hepatitis B reactivation.)

  12. History of malignancy of any organ system (other than localized basal cell carcinomaof the skin or in situ cervical cancer), treated or untreated, within the past 5years, 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 withbreastfeeding or confound the study assessment in the opinion of the Investigator.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Ofatunumab
Phase: 4
Study Start date:
November 25, 2024
Estimated Completion Date:
February 23, 2027

Study Description

This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year. The study consists of a Core Part and a Safety Follow-up Part. The Core Part includes a Screening period and a Sampling period. During the Screening period (up to 4 weeks), the study doctor will assess if mothers can join the study. The Sampling period, during which milk samples and a blood sample will be collected, will last for up to 12 weeks. The Safety Follow-up Part will last for about 9 months, to follow up on health and safety of mothers and their babies.

Connect with a study center

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hamburg, 22179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Caribbean Center for Clinical Research, Inc

    Guaynabo, 00968
    Puerto Rico

    Active - Recruiting

  • Novartis Investigative Site

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • UCSF

    San Francisco, California 94115
    United States

    Active - Recruiting

  • UCSF .

    San Francisco, California 94115
    United States

    Active - Recruiting

  • UC Health Neuroscience Ctr

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Northwestern Medicine Northwestern University

    Winfield, Illinois 60190
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Brookline, Massachusetts 02445
    United States

    Active - Recruiting

  • Duke Neurology

    Durham, North Carolina 27110
    United States

    Active - Recruiting

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