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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 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.

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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.

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

FieldValue
Enrollment Target 196 participants
Start Date 2025-03-13
Est. Completion 2030-03-23
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT06869785

The ClinicalTrials.gov registry entry for NCT06869785 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 731-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (73% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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