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

Last Update: Apr 24, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157Q12301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Relapsing Multiple Sclerosis (RMS)
Phase3
Recruiting
180
Mar 13, 2025
May 26, 2031
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

Ofatumumab approved dose

Approved dosage
Biological

Ofatumumab new dose

New dosage

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

Sana Research

Recruiting

Falls Church,Virginia,22042,United States

Henry Tran
Victoria Mantyla

MS Comprehensive Care Ctr at Holy Name Hospi

Recruiting

Teaneck,New Jersey,07666,United States

Asya Wallach
Donna Di Carlo

Neurology Associates of Ormond Beach

Recruiting

Ormond Beach,Florida,32174,United States

Teresa Hartman
James Scott

Neurology of Central FL Res Ctr

Recruiting

Altamonte Springs,Florida,32714,United States

Alicia Cabrera
Raisa Brana

Mid Atlantic Epilepsy and Sleep Ctr

Recruiting

Bethesda,Maryland,20817,United States

Jonathan Ross
Salman Hashmi

Mountain Neuro Research Center PC

Recruiting

Basalt,Colorado,81621,United States

Mary Michelle Koboski
Alison Brooke Allen

CenExcel Clinical Research

Recruiting

Salt Lake City,Utah,84107,United States

Nirav Patel
Hanna Voltattorni

Vero Beach Neurology

Recruiting

Vero Beach,Florida,32960,United States

Christopher Stevens
Stuart Shafer

Tallahassee Neurological Clinic

Recruiting

Tallahassee,Florida,32308,United States

Jordan Barnett
Winston Ortiz

Elite Clinical Research

Recruiting

Miami,Florida,33144,United States

Alina Salazar
Gelasio A Baras

MultiCare Research Institute for Research and Innovation

Recruiting

Tacoma,Washington,98405,United States

Stacy Donlon

Fullerton Neuro and Headache Ctr

Recruiting

Fullerton,California,92835,United States

Jack H Florin
Vanessa Mariscal

Dayton Center for Neurological Disorders

Recruiting

Centerville,Ohio,45459,United States

Derek Menkedick
Jordan Difatta

Rochester Cent For Behavioral

Recruiting

Rochester Hills,Michigan,48307,United States

Esther Young
Layal Bou Harfouch

Orlando Health Clinical Trials

Recruiting

Orlando,Florida,32806,United States

Amparo Gutierrez
Mariangelis Floresvega

Josephson Wallack Munshower Neurology P.C

Recruiting

Indianapolis,Indiana,46256,United States

Craig Edward Herrman
Skyla Baird

Axiom Brain Health

Recruiting

Tampa,Florida,33609,United States

Jennifer Fornes
Mark Cascione

Aqualane Clinical Research

Recruiting

Naples,Florida,34105,United States

Eve Cowens
Matthew J Baker

Neurology Clinic PC

Recruiting

Cordova,Tennessee,38018,United States

Kendrick K Henderson
Vickie Johnson

Velocity Clinical Trials

Recruiting

Los Angeles,California,90057,United States

Mary Long
Oliver Achi

WA Uni School Of Med

Recruiting

Saint Louis,Missouri,63110,United States

Katherine Bircher
Robert Naismith

Sibyl Wray MD Neurology PC

Recruiting

Knoxville,Tennessee,37922,United States

Kim Puccio
Sibyl Wray

Washington Hospital Center

Recruiting

Washington,District of Columbia,20010,United States

Brian Barry
Yemisrach Tadesse

Delricht Research

Recruiting

New Orleans,Louisiana,70115,United States

Jon Olson
Kandice Lemoine

University Of South Florida

Recruiting

Tampa,Florida,33612,United States

Natalie Moreo
Samantha Peralta

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals


Source URL: https://prod1.novartis.com/clinicaltrials/study/nct06869785

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  1. https://clinicaltrials.gov/ct2/show/NCT06869785
  2. #trial-eligibility
  3. mailto:vmantyla@sanaresearch.com
  4. tel:+1 201 837 0727#128
  5. mailto:ddicarlo@holyname.org
  6. tel:386-676-6340
  7. mailto:thartman@naobresearch.com
  8. tel:407-790-4990
  9. mailto:raisaresearchcfl@gmail.com
  10. tel:301-530-9744
  11. mailto:hashmis@epilepsydc.com
  12. mailto:marymichelle@rfneurology.com
  13. mailto:h.voltattorni@cenexel.com
  14. tel:772-569-7039
  15. mailto:cstevens@geodysseyrsch.com
  16. tel:850-878-8121
  17. mailto:jnb23@fsu.edu
  18. tel:305-262-3396
  19. mailto:asalazar@eliteclinicalresearch.com
  20. tel:253-403-7449
  21. tel:714-738-0800
  22. mailto:vmariscal@fullertonneuro.net
  23. tel:937-439-6168
  24. mailto:jdifatta@dcndinc.com
  25. mailto:layal.bouharfouch@profoundresearch.io
  26. tel:407-352-5434
  27. mailto:Mariangelis.Floresvega@orlandohealth.com
  28. tel:+1 (317) 537-6060
  29. mailto:sbaird@jwmneuro.com
  30. mailto:jfornes@axiombrainhealth.com
  31. tel:239-434-0332
  32. mailto:eve@aqualaneresearch.com
  33. tel:901-866-9252
  34. mailto:vjohnson@neuroclinic.org
  35. mailto:mlong@velocityclinical.com
  36. mailto:bircher@wustl.edu
  37. tel:865-218-6222
  38. mailto:kpuccio@hopeneuro.com
  39. mailto:yemisrach.g.tadesse@medstar.net
  40. mailto:klemoine@delricht.com
  41. tel:813-974-8859
  42. mailto:smgarcia2@usf.edu
  43. tel:1-888-669-6682
  44. mailto:novartis.email@novartis.com