Concentration of Ofatumumab in the Breast Milk of Lactating Women With

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

Running, not recruitingPhase 4Relapsing MSNCT064441132023-505283-11-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ofatunumab
  • OFATUMUMAB

What it measured

Main measures

  • Concentration of ofatumumab in breast milk.

    (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"

  • The concentration of ofatumumab in breast milk at the following timepoints: (pre-dose) on the day of the second (or any subsequent) maintenance dose, then 7, 14, 21 and (pre-dose) 28 days after the second (or any subsequent) maintenance dose.

Other measures (13)

  • Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum

    28 days after second(or subsequent) maintenance dose.

    How the body handles the medicine

  • Estimation of relative infant dose of ofatumumab

    28 days after second (or subsequent) maintenance dose.

  • Safety data collected in lactating women receiving ofatumumab and their breastfed infants

    Upto 12 months

    Safety

  • Plasma Pharmacokinetics of OMB157(Cmax)

    over 28 days after the second (or any subsequent) maintenance dose.

    How the body handles the medicine

  • Plasma Pharmacokinetics of OMB157(AUC)

    over 28 days

    How the body handles the medicine

  • Plasma Pharmacokinetics of OMB157 (M/P Ratio)

    at 28 days after the second or any subsequent maintenance dose.

    How the body handles the medicine

  • Proportion of participants with at least 1 sample with quantifiable ofatumumab concentrations in breast milk

  • Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.

    How the body handles the medicine

  • The exposure (area under the curve (AUC) of ofatumumab in milk over 28 days (from the second or any subsequent maintenance dose to the next maintenance dose after initiation or re-initiation of ofatumumab post-partum)

    How the body handles the medicine

  • Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.

Who could take part

Relapsing MS · 18 to 100

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Nov 2024

    2. Main results due

      Feb 2026

    3. Finished

      Oct 2026

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