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Active, not recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT06444113

Public ClinicalTrials.gov record NCT06444113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06444113
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 25, 2024 (Actual)
Primary completion
Feb 20, 2026 (Actual)
Completion
Oct 29, 2026 (Estimated)
Last update posted
Aug 12, 2026

2024 – 2026

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
UCSF San Francisco California 94115 —
UC Health Neuroscience Ctr Aurora Colorado 80045 —
Northwestern Medicine Northwestern University Winfield Illinois 60190 —
Brigham and Womens Hospital Brookline Massachusetts 02445 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06444113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06444113 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →