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NCT06869785 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
A Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 196
- Enrollment target
- 20
- Study locations
NCT06869785: Active Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by Novartis Pharmaceuticals.
NCT06869785 is a Phase 3 study of Relapsing Multiple Sclerosis (RMS) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 196 participants, below the 731-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06869785, a Phase 3 study of Relapsing Multiple Sclerosis (RMS), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 196 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
Conditions Studied
Interventions
- BIOLOGICAL Ofatumumab approved dose
- BIOLOGICAL Ofatumumab new dose
Study Locations (20)
Florida
- Neurology of Central FL Res Ctr - Altamonte Springs
- Neurology Offices Of South Florida - Boca Raton
- First Choice Neurology - Boca Raton
- University of Florida - Gainesville
- Memorial Healthcare System - Hollywood
- Neurology Associates PA - Maitland
- UM Department Of Neurology - Miami
- Elite Clinical Research - Miami
California
- The Research and Education Inst. of Alta Bates Summit Med. Grp - Berkeley
- Fullerton Neuro and Headache Ctr - Fullerton
- University of California Irvine - Irvine
- CenExcel Clinical Research - Los Alamitos
- Velocity Clinical Trials - Los Angeles
- Regina Berkovich MD PhD Inc - West Hollywood
Arizona
- Xenoscience Inc - Phoenix
- Ctr for Neurology and Spine - Phoenix
- Phoenix Neurological Associates - Phoenix
Alabama
- Alabama Neurology Associates PC - Birmingham
Colorado
- CU Anschutz Med Campus - Aurora
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2025-03-13 |
| Est. Completion | 2030-03-23 |
| Phase | Phase 3 |
What the registry record for NCT06869785 still lists
NCT06869785 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 731-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis (RMS) appearing as the primary indexed condition, and to 2 interventions - of which Ofatumumab approved dose is the first listed.
NCT06869785 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06869785 about?
NCT06869785 is a clinical study titled "Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab". This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
What is the current status of trial NCT06869785?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2025-03-13. Estimated completion is 2030-03-23.
What conditions does trial NCT06869785 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis (RMS).
What interventions are being tested in trial NCT06869785?
The interventions under investigation include: Ofatumumab approved dose (BIOLOGICAL), Ofatumumab new dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT06869785?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06869785 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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