NCT06444113

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Sclerosis

Interventions

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

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-05-18
• Completion: 2026-10-29
• First posted: 2024-06-05
• Last updated: 2026-03-27

Locations

15 sites across 5 countries: United States, Germany, Italy, Poland, United Kingdom

Regulatory

• FDA-regulated drug study