Last Update: Aug 27, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157G2410
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Multiple Sclerosis
Phase4
Recruiting
20
Aug 30, 2024
Feb 02, 2026
Female
18 Years - (Adult, Older Adult)

Interventions

Drug

Ofatunumab

No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.

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.

Study Location

Novartis Investigative Site

Recruiting

Hamburg,22179,Germany

Novartis Investigative Site

Recruiting

London,Wc1n 3bg,United Kingdom

UCSF .

Recruiting

San Francisco,California,94115,United States

Riley Bove
Ayushi Balan

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