A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation (SOSTOS)

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Novartis

Status and phase

Enrolling
Phase 4

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: Ofatumumab
Drug: Disease modifying treatment (DMT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05090371
COMB157GUS09

Details and patient eligibility

About

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

Full description

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab. After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held. The total study duration is 21 months plus 1 week for screening/qualification.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent must be obtained prior to participation in the study.
  • Age 18-45 years
  • Diagnosis of RRMS per McDonald Criteria (2017)
  • EDSS 0-5.5 (Inclusive)
  • Able to obtain MRI and attend study visits at sites
  • Willing to use wearable device as specified in the protocol
  • Able to provide blood sample
  • On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening
  • No relapse reported within 6 months prior to Screening
  • Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.

Exclusion criteria

  • Primary progressive or secondary progressive phenotype
  • Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
  • Use of experimental or investigational drugs for MS within 2 years from Screening
  • Known sensitivity to gadolinium
  • Central Nervous System (CNS) anomalies that are better accounted for by another disease process
  • Known active malignancies
  • Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
  • Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies
  • Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
  • IgG or IgM levels below lower limit of normal (LLN) at Screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Ofatumumab
Experimental group
Description:
20 mg
Treatment:
Drug: Ofatumumab
DMT continued therapy
Active Comparator group
Description:
Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
Treatment:
Drug: Disease modifying treatment (DMT)

Trial contacts and locations

33

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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