Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab

Phase 3

Recruiting

• Conditions: Relapsing Multiple Sclerosis (RMS)
• Interventions: Biological: Ofatumumab approved dose; Biological: Ofatumumab new dose

• Registration Number: NCT06869785
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-11
• Study Start: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-12-24
• Study Completion: 2031-05-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Signed informed consent must be obtained prior to participation in the study.
• Male or female study participants aged 18 to 60 years (inclusive) at screening.
• Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS).

Exclusion Criteria

• Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants.
• Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML.
• Participants at risk of developing or having reactivation of hepatitis
• Emergence of active chronic disease (or stable but treated with immune therapy) prior to Day 1 of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).
• Pregnant or nursing (lactating) women
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months).
• Participants taking prohibited therapies, including B cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab)

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ofatumumab dose 1	Ofatumumab approved dose	Approved dosage
Ofatumumab dose 1	Ofatumumab new dose	Approved dosage
Ofatumumab dose 2	Ofatumumab new dose	New dosage

Primary Outcome Measures

Name	Time	Method
Ofatumumab plasma pharmacokinetics - area under the curve	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration	Up to 12 weeks
Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration	Up to 12 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE)	Up to 52 weeks
Proportion of participants with anti-drug antibodies	Up to 52 weeks
Participant B cell counts	Up to 52 weeks

Trial Locations

Locations (25)

Elite Clinical Research; 🇺🇸 Miami, Florida, United States

Fullerton Neuro and Headache Ctr; 🇺🇸 Fullerton, California, United States

Velocity Clinical Trials; 🇺🇸 Los Angeles, California, United States

Josephson Wallack Munshower Neurology P.C; 🇺🇸 Indianapolis, Indiana, United States

Rochester Cent For Behavioral; 🇺🇸 Rochester Hills, Michigan, United States

WA Uni School Of Med; 🇺🇸 Saint Louis, Missouri, United States

MS Comprehensive Care Ctr at Holy Name Hospi; 🇺🇸 Teaneck, New Jersey, United States

Dayton Center for Neurological Disorders; 🇺🇸 Centerville, Ohio, United States

Orlando Health Clinical Trials; 🇺🇸 Orlando, Florida, United States

Mountain Neuro Research Center PC; 🇺🇸 Basalt, Colorado, United States

Aqualane Clinical Research; 🇺🇸 Naples, Florida, United States

Tallahassee Neurological Clinic; 🇺🇸 Tallahassee, Florida, United States

Axiom Brain Health; 🇺🇸 Tampa, Florida, United States

University Of South Florida; 🇺🇸 Tampa, Florida, United States

Neurology Associates of Ormond Beach; 🇺🇸 Ormond Beach, Florida, United States

Mid Atlantic Epilepsy and Sleep Ctr; 🇺🇸 Bethesda, Maryland, United States

Neurology of Central FL Res Ctr; 🇺🇸 Altamonte Springs, Florida, United States

CenExcel Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Vero Beach Neurology; 🇺🇸 Vero Beach, Florida, United States

Neurology Clinic PC; 🇺🇸 Cordova, Tennessee, United States

Delricht Research; 🇺🇸 New Orleans, Louisiana, United States

MultiCare Research Institute for Research and Innovation; 🇺🇸 Tacoma, Washington, United States

Sibyl Wray MD Neurology PC; 🇺🇸 Knoxville, Tennessee, United States

Sana Research; 🇺🇸 Falls Church, Virginia, United States