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NCT06444113 · ClinicalTrials.gov registry record · Phase 4
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
A Phase 4 study of Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT06444113: Recruiting Phase 4 study of Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT06444113 is a Phase 4 study of Multiple Sclerosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06444113, a Phase 4 study of Multiple Sclerosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.
Conditions Studied
Interventions
- DRUG Ofatunumab
Study Locations (20)
Other
- Novartis Investigative Site - Bochum
- Novartis Investigative Site - Hamburg
- Novartis Investigative Site - Tübingen
- Novartis Investigative Site - Bialystok
- Novartis Investigative Site - Kielce
- Novartis Investigative Site - Krakow
- Novartis Investigative Site - Rzeszów
- Novartis Investigative Site - Zabrze
- Caribbean Center for Clinical Research, Inc - Guaynabo
- Novartis Investigative Site - Cambridge
- Novartis Investigative Site - London
California
- UCSF - San Francisco
Colorado
- UC Health Neuroscience Ctr - Aurora
Illinois
- Northwestern Medicine Northwestern University - Winfield
Massachusetts
- Brigham and Womens Hospital - Brookline
North Carolina
- Duke Neurology - Durham
Bavaria
- Novartis Investigative Site - Munich
FG
- Novartis Investigative Site - Foggia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2027-02-23 |
| Phase | Phase 4 |
What NCT06444113 shows while recruiting
NCT06444113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ofatunumab is the first listed.
NCT06444113 names 20 study sites across 10 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06444113 about?
NCT06444113 is a clinical study titled "Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis". 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.
What is the current status of trial NCT06444113?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-11-25. Estimated completion is 2027-02-23.
What conditions does trial NCT06444113 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT06444113?
The interventions under investigation include: Ofatunumab (DRUG).
Who is sponsoring clinical trial NCT06444113?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06444113 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06444113's enrollment target sits among peer trials
20 262nd of 315 higher than 41 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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