A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

  • days left to enroll
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 12 September 2021


To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT.


Vaccinations against influenza are an important part of effective management of multiple sclerosis (MS).

Ofatumumab is a human anti-CD20 monoclonal antibody (mAb) which depletes B-cells, a component of the immune system. This study investigates if ofatumumab treated patients can have an immune response that may be protective after receiving the influenza vaccine.

There will be a one week screening period to assess eligibility for the trial. All eligible participants will receive an influenza vaccine during the Screening Period prior to the Investigational Period. This study will enroll 66 participants with relapsing multiple sclerosis into three cohorts in multiple centers. Up to 44 of the participants will begin treatment with ofatumumab or will already be receiving commercial ofatumumab. The remaining 22 participants will remain on their Injectable Disease Modifying Therapy (iDMT). There will be 4 weekly visits during the Investigational Period which will last 4 weeks. There will also be an optional, 6 month Extension Period for Cohorts 1 and 2, who received ofatumumab, to further evaluate immune response. Cohort 3 will not enter the Extension Period.

Condition Relapsing Multiple Sclerosis
Treatment Ofatumumab, Quadrivalent Influenza Vaccine
Clinical Study IdentifierNCT04667117
SponsorNovartis Pharmaceuticals
Last Modified on12 September 2021


Yes No Not Sure

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study
Age 18-55 years old
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Must be willing to comply with the study schedule
Planning to receive a 2020-2021 inactivated influenza vaccine
Planning to start treatment with ofatumumab or already on commercially prescribed ofatumumab for at least 2 weeks prior to the screening visit
Participants in Cohort 3 must fulfill criteria 1-5 above in addition to the
\. Participant must currently be receiving iDMT

Exclusion Criteria

Already has received the 2020-2021 season influenza vaccine
Known hypersensitivity to any component of the influenza vaccine
Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to Week 0
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to or oral antibiotics within two weeks prior to Week 0
Known clinical diagnosis of influenza infection during the 2020-2021 influenza season prior to starting the study based on investigator's or subject's personal physician's judgement (laboratory report of confirmed influenza infection is not required)
Prior treatment with B-cell targeted therapies (e.g., rituximab or ocrelizumab), lymphocyte-trafficking blockers, alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, bone marrow transplantation. Treatment with a natalizumab within 6 months of week 0
Treatment with an S1P modulator within 60 days prior to Week 0
Participants with any known active systemic bacterial, fungal or viral or fungal infections (such as hepatitis, progressive multifocal leukocencephalopathy, COVID-19 or HIV), or known to have acquired immunodeficiency syndrome (AIDS)
Participation in another interventional clinical trial within 14 days prior to the screening visit
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Women of child-bearing potential
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note