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

An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

ClinicalTrials.gov Identifier: NCT04667117

Novartis Reference Number: COMB157GUS12

Last Update: Sep 01, 2021

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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

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.

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jan 14, 2021
Completion date 
Jul 06, 2022
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Biological
Quadrivalent influenza vaccine
2020-2021 inactivated quadrivalent influenza vaccine
Drug
Ofatumumab
Auto-injector containing 20 mg sc ofatumumab (20 mg/0.4ml) for subcutaneous administration. Novartis will supply participants in Cohort 1 with ofatumumab treatment in the Investigational Period and the optional 6-month Extension Period. Participants in Cohort 2 will continue on their commercially prescribed ofatumumab treatment during the Investigational Period. Novartis will supply participants in Cohort 2 with ofatumumab treatment in the optional 6-month Extension Period.

Eligibility Criteria

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 following:

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85018
Arizona
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63131
Missouri
United States
Novartis Investigative Site
Recruiting
Vienna, 22182
Virginia
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]