Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

ClinicalTrials.gov Identifier: NCT05084638

Novartis Reference Number: COMB157GUS10

Last Update: Mar 02, 2022

See if you pre-qualify

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 impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.

Condition 
Relapse Remitting Multiple Sclerosis
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jan 25, 2022
Completion date 
Mar 20, 2026
Gender 
All
Age(s)
18 Years - 35 Years (Adult)

Interventions

Drug
Ofatumumab
20mg subcutaneous injection

Eligibility Criteria

Key Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

Signed informed consent must be obtained prior to participation in the study

Age 18-35 years

Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:

Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device

Able to provide blood sample (no CSF will be collected in HC)

Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:

Diagnosis of RRMS per McDonald Criteria (2010/2017)
Within 6 months of diagnosis of clinically definite MS (CDMS)
EDSS 0-3.0 (Inclusive)
Treatment-naïve to MS DMT
Able to obtain MRI and attend study visits at sites
Able to use wearable device
Able to provide blood sample (and CSF for sub-group n=15)

Key Exclusion Criteria:

Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study:

Confounding medical condition as determined by the investigator

RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study:

Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
Use of experimental or investigational drugs for MS
Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
Relapse between screening and Baseline visits
Known sensitivity to gadolinium; patients with chronic, severe kidney disease
Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
Known active malignancies
Pregnant or nursing (lactating) women
Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
Patients with IgG or IgM levels below LLN at Screening
Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
Patients at risk of developing or having reactivation of hepatitis

Study Locations

United States
Novartis Investigative Site
Recruiting
Knoxville, 37922
Tennessee
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

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