Clinical trial NCT06869785: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
Official title: An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis (RMS)
Keywords: Relapsing Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ofatumumab plasma pharmacokinetics - area under the curve
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration
timeFrame: Up to 12 weeks
measure: Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration
timeFrame: Up to 12 weeks
measure: Incidence of Adverse events (AE) and Serious adverse events (SAE)
timeFrame: Up to 52 weeks
measure: Proportion of participants with anti-drug antibodies
timeFrame: Up to 52 weeks
measure: Participant B cell counts
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates PC
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience Inc
state: Arizona
city: Phoenix
country: United States
facility: Ctr for Neurology and Spine
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Neurological Associates
state: Arizona
city: Fullerton
country: United States
facility: Fullerton Neuro and Headache Ctr
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Trials
state: California
city: West Hollywood
country: United States
facility: Regina Berkovich MD PhD Inc
state: California
city: Basalt
country: United States
facility: Mountain Neuro Research Center PC
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Neurology of Central FL Res Ctr
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices Of South Florida
state: Florida
city: Boca Raton
country: United States
facility: First Choice Neurology
state: Florida
city: Hollywood
country: United States
facility: Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Elite Clinical Research
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Orlando
country: United States
facility: Orlando Health Clinical Trials
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: Axiom Brain Health
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Ms Center Of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C
state: Indiana
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Bethesda
country: United States
facility: Mid Atlantic Epilepsy and Sleep Ctr
state: Maryland
city: Rochester Hills
country: United States
facility: Rochester Cent For Behavioral
state: Michigan
city: Saint Louis
country: United States
facility: WA Uni School Of Med
state: Missouri
city: Teaneck
country: United States
facility: MS Comprehensive Care Ctr at Holy Name Hospi
state: New Jersey
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Columbus
country: United States
facility: OSU Medical Center-Martha Morehouse Medical Plaza
state: Ohio
city: Cordova
country: United States
facility: Neurology Clinic PC
state: Tennessee
city: Knoxville
country: United States
facility: Sibyl Wray MD Neurology PC
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants Of Dallas PA
state: Texas
city: Salt Lake City
country: United States
facility: CenExcel Clinical Research
state: Utah
city: Falls Church
country: United States
facility: Sana Research
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Research Institute for Research and Innovation
state: Washington
city: Caguas
country: Puerto Rico
facility: Puerto Rico Multiple Sclerosis Ctr
city: Guaynabo
country: Puerto Rico
facility: Caribbean Center for Clinical Research, Inc
Study officials:
References: