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NCT06444113 · ClinicalTrials.gov record · last posted 2026-08-12

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

Name: Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis — clinical trial record (NCT06444113)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: KATHAROS

StatusActive, Not Recruiting

PhasePhase 4

SponsorNovartis Pharmaceuticals

Started2024-11-25

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 1 change detected by DataLookout

2026-06-27

Primary completion moved earlier: 2026-05-18 → 2026-02-20

Trial Details

NCT Number	NCT06444113
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Multiple Sclerosis
Enrollment	24 participants
Start Date	2024-11-25
Primary Completion	2026-02-20 (estimated)
Study Completion	2026-10-29 (estimated)
Updated on ClinicalTrials.gov	2026-08-12