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

NCT06444113 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: COMB157G24102023-505283-11-00
• Study Type: interventional
• Target: 24
• Locations: 5 countries
• Sites: 15

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Lactating women,; multiple sclerosis (MS); ofatumumab; milk concentration; breastfed infant

Outcome Measures

Primary Outcomes (1)

• Concentration of ofatumumab in breast milk.

  Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.

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

Secondary Outcomes (6)

• 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.

• 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

• Plasma Pharmacokinetics of OMB157(Cmax)

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

• Plasma Pharmacokinetics of OMB157(AUC)

  over 28 days

Study Arms (1)

Ofatunumab

EXPERIMENTAL

Recommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4.

Drug: Ofatunumab

Interventions

Ofatunumab DRUG

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

Ofatunumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any study assessment is performed.
• Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
• Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
• Participant has delivered term infant (at least 37 weeks gestation).
• 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.

You may not qualify if:

• 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.
• Participant taking medications prohibited by the study protocol at screening.
• Pregnant woman, confirmed by positive serum pregnancy test during screening.
• Female of childbearing potential should use effective contraception as per local label.
• Participant has history of chronic alcohol abuse or drug abuse in the last year.
• 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.
• Participant has history of breast implants, breast augmentation, or breast reduction surgery.
• Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
• Active infections, including mastitis (participant may be included once the infection is resolved).
• Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
• 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.)
• 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.
• Any contraindication as per local label.
• Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

UCSF

San Francisco, California, 94115, United States

Location

UC Health Neuroscience Ctr

Aurora, Colorado, 80045, United States

Location

Northwestern Medicine Northwestern University

Winfield, Illinois, 60190, United States

Location

Brigham and Womens Hospital

Brookline, Massachusetts, 02445, United States

Location

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Hamburg, 22179, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Foggia, FG, 71122, Italy

Location

Novartis Investigative Site

Bialystok, 15 276, Poland

Location

Novartis Investigative Site

Kielce, 25 726, Poland

Location

Novartis Investigative Site

Cambridge, CB2 0QQ, United Kingdom

Location

Novartis Investigative Site

London, NW1 2BU, United Kingdom

Location

Novartis Investigative Site

Oxford, OX3 9DU, United Kingdom

Location

Novartis Investigative Site

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: November 25, 2024
• Primary Completion: May 18, 2026
• Study Completion (Estimated): October 29, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); GB (4); DE (4); PL (2); US (4)