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

Last updated: March 26, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Memory Loss

Neurologic Disorders

Scar Tissue

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: 24
Treatment Group(s): 1
Primary Treatment: Ofatunumab
Phase: 4
Study Start date:
November 25, 2024
Estimated Completion Date:
October 29, 2026

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

    Munich, Bavaria 81377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munich 2867714, Bavaria 2951839 81377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg 2911298, 22179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Foggia, FG 71122
    Italy

    Site Not Available

  • Novartis Investigative Site

    Foggia 3176885, FG 71122
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma 8957247, RM 00133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino 8980539, TO 10126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bialystok, 15 276
    Poland

    Site Not Available

  • Novartis Investigative Site

    Bialystok 776069, 15 276
    Poland

    Site Not Available

  • Novartis Investigative Site

    Kielce, 25 726
    Poland

    Site Not Available

  • Novartis Investigative Site

    Kielce 769250, 25 726
    Poland

    Site Not Available

  • Novartis Investigative Site

    Krakow, 31 531
    Poland

    Site Not Available

  • Novartis Investigative Site

    Krakow 3094802, 31 531
    Poland

    Site Not Available

  • Novartis Investigative Site

    Rzeszow, 35-323
    Poland

    Site Not Available

  • Novartis Investigative Site

    Rzeszów 759734, 35-323
    Poland

    Site Not Available

  • Novartis Investigative Site

    Zabrze 3080985, 41-800
    Poland

    Site Not Available

  • Caribbean Center for Clinical Research, Inc

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Center for Clinical Research, Inc

    Guaynabo 4565119, 00968
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London 2643743, NW1 2BU
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Oxford 2640729, OX3 9DU
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Salford 2638671, M6 8HD
    United Kingdom

    Site Not Available

  • UCSF

    San Francisco, California 94115
    United States

    Site Not Available

  • UCSF .

    San Francisco, California 94115
    United States

    Active - Recruiting

  • UCSF

    San Francisco 5391959, California 5332921 94115
    United States

    Site Not Available

  • UC Health Neuroscience Ctr

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UC Health Neuroscience Ctr

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Northwestern Medicine Northwestern University

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Northwestern Medicine Northwestern University

    Winfield 4916826, Illinois 4896861 60190
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Brookline, Massachusetts 02445
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Brookline 4931482, Massachusetts 6254926 02445
    United States

    Site Not Available

  • Duke Neurology

    Durham, North Carolina 27110
    United States

    Site Not Available

  • Duke Neurology

    Durham 4464368, North Carolina 4482348 27110
    United States

    Site Not Available

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