What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include anti-CD20 monoclonal antibodies like Ofatumumab, as well as other disease-modifying therapies (DMTs) such as glatiramer acetate, dimethyl fumarate, and natalizumab. Ofatumumab and similar anti-CD20 therapies can cause side effects such as infusion-related reactions, infections, and potential liver enzyme elevations. Glatiramer acetate may lead to injection site reactions and lipoatrophy. Dimethyl fumarate is associated with gastrointestinal issues and flushing. Natalizumab carries a risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection, especially in patients with prior immunosuppressant use or positive anti-JCV antibodies.

What prior FDA approvals exist?

Ofatumumab is an anti-CD20 monoclonal antibody used in the treatment of Multiple Sclerosis (MS). Similar FDA-approved treatments include Ocrelizumab, another anti-CD20 monoclonal antibody, which has been approved for both relapsing forms of MS and primary progressive MS. These treatments work by targeting and depleting B-cells, which are believed to play a role in the autoimmune response associated with MS. Other FDA-approved treatments for MS include interferon beta formulations, glatiramer acetate, and oral medications like dimethyl fumarate and fingolimod, which have different mechanisms of action aimed at reducing relapse rates and slowing disease progression.

What other types of research exist?

Promising novel alternatives to Ofatumumab for Multiple Sclerosis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown potential in immune-mediated disorders. 2) Alemtuzumab, which has demonstrated efficacy in relapsing-remitting MS. 3) Natalizumab, particularly with extended interval dosing to reduce risks. These therapies offer different mechanisms of action and have shown positive outcomes in clinical trials.

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Ofatumumab for Multiple Sclerosis (SOSTOS Trial)

Phase 4

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-45 years

Diagnosis of RRMS per McDonald Criteria (2017)

Must not have

Primary progressive or secondary progressive phenotype

Diseases other than multiple sclerosis responsible for the clinical or MRI presentation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 3 to15

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will test if patients with a specific type of multiple sclerosis benefit from switching to a new medication. The medication aims to reduce harmful cells in the nervous system, potentially preventing future issues. It has been approved in several countries for treating this condition.

Who is the study for?

This trial is for adults aged 18-45 with relapsing-remitting multiple sclerosis (RRMS) who haven't had a relapse in the past year and have been on a disease-modifying treatment for at least six months. Participants should be able to attend study visits, use a wearable device, provide blood samples, and have an EDSS score of 0-5.5. Those with other diseases mimicking MS symptoms or active infections like COVID-19 cannot join.

What is being tested?

The study tests if switching to Ofatumumab is beneficial for RRMS patients showing no recent relapses but elevated neurofilament light levels compared to staying on their current therapy. It explores whether this biomarker predicts better outcomes with Ofatumumab.

What are the potential side effects?

Ofatumumab may cause side effects such as infusion reactions, infections due to immune system changes, and possibly allergic responses in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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I have been diagnosed with relapsing-remitting MS according to the 2017 criteria.

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My disability level allows me to walk, at least with assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is progressively worsening without relapses.

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My symptoms or MRI results are not caused by multiple sclerosis.

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My brain or spinal cord issues are caused by another condition, not my current illness.

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I have another active cancer.

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I have a chronic immune system condition other than MS, being treated.

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I do not have any active infections, including COVID-19, and I am not HIV positive.

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I have symptoms or a diagnosis of PML.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 3 to 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 3 to 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 to 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)

Secondary study objectives

Annualized relapse rate in Months 3 to 15

Mean change from Baseline in T1

Mean change in Gd+ lesion count

+13 more

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522

50%

Diarrhoea

34%

Neutropenia

29%

Pyrexia

25%

Anaemia

24%

Nausea

23%

Cough

17%

Thrombocytopenia

17%

Constipation

16%

Fatigue

16%

Pneumonia

15%

Vomiting

15%

Decreased appetite

14%

Upper respiratory tract infection

13%

Asthenia

13%

Colitis

13%

Weight decreased

13%

Bronchitis

11%

Abdominal pain

11%

Rash

10%

Hypokalaemia

10%

Oedema peripheral

Aspartate aminotransferase increased

Dyspnoea

Alanine aminotransferase increased

Back pain

Dizziness

Headache

Hypertension

Nasopharyngitis

Arthralgia

Pruritus

Hyperkalaemia

Respiratory tract infection

Rash maculo-papular

Febrile neutropenia

Rhinorrhoea

Dyspepsia

Pain in extremity

Abdominal pain upper

Dehydration

Insomnia

Productive cough

Dry mouth

Muscle spasms

Paraesthesia

Pneumonitis

Toxic skin eruption

Hypotension

Renal failure acute

General physical health deterioration

Gastroenteritis

Gastritis

Pneumonia pseudomonas aeruginosa

Pancytopenia

Cardiac failure

Sepsis

Pneumocystis jirovecii pneumonia

Pneumonia pneumococcal

Pulmonary embolism

Urinary tract infection

Pneumonia klebsiella

Accidental overdose

Respiratory failure

Streptococcal sepsis

Skin infection

Pneumonia staphylococcal

Interstitial lung disease

Rash erythematous

Pneumonia aspiration

Fungal oesophagitis

Pleural haemorrhage

Upper gastrointestinal haemorrhage

Proctitis

Enterocolitis

Mental impairment

Intestinal adenocarcinoma

Deep vein thrombosis

Haemolytic anaemia

Atrial fibrillation

Cardiac failure congestive

Myocardial infarction

Pericarditis

Death

Mucosal inflammation

Multi-organ failure

Sudden death

Transitional cell carcinoma

Bronchiolitis

Bronchitis viral

Bronchopneumonia

Cytomegalovirus colitis

Pneumonia escherichia

Pneumonia mycoplasmal

Septic shock

Streptococcal bacteraemia

Subdural haematoma

Lipase increased

Nephrolithiasis

Renal colic

Renal failure

Renal failure chronic

Lung disorder

Ventricular tachycardia

Colitis ischaemic

Enteritis

Pancreatitis acute

Ileal ulcer

Aspergillus infection

Bronchopulmonary aspergillosis

Campylobacter gastroenteritis

Clostridium difficile colitis

Fungal infection

Influenza

Pseudomonal sepsis

Lower respiratory tract infection

Pneumonia bacterial

Enterococcal infection

Enterococcal sepsis

Escherichia sepsis

Escherichia urinary tract infection

Gastroenteritis viral

Haemophilus infection

Infection

Infusion site cellulitis

Lobar pneumonia

Lower respiratory tract infection viral

Lung infection

Pneumonia respiratory syncytial viral

Pneumonia streptococcal

Pseudomonas bronchitis

Wound infection staphylococcal

Cervical vertebral fracture

Femur fracture

Traumatic haematoma

Malnutrition

Hyponatraemia

Tumour lysis syndrome

Arthritis

Bone pain

Malignant melanoma

Brain stem haemorrhage

Dementia

Acute respiratory distress syndrome

Acute respiratory failure

Chronic obstructive pulmonary disease

Dermatitis exfoliative

Thrombosis

Infusion related reaction

Neuroendocrine tumour

Pleural effusion

Mallory-Weiss syndrome

Diverticulitis

Pyelonephritis

Haemorrhagic stroke

Dermatitis allergic

Respiratory tract infection bacterial

Splenic rupture

Neuroendocrine carcinoma of the skin

100%

80%

60%

40%

20%

Study treatment Arm

Duvelisib

Ofatumumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OfatumumabExperimental Treatment1 Intervention

20 mg

Group II: DMT continued therapyActive Control1 Intervention

Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ofatumumab

2013

Completed Phase 3

~1460

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments primarily aim to modulate the immune system to reduce inflammation and prevent further damage to the nervous system. Ofatumumab, like other anti-CD20 monoclonal antibodies (e.g., Ocrelizumab), targets CD20 proteins on B-cells, leading to their depletion and reducing the immune response that attacks myelin. This is crucial for MS patients as it helps to decrease the frequency of relapses and slow disease progression. Other common treatments include interferon beta, which reduces inflammation and modulates the immune response, and glatiramer acetate, which mimics myelin protein to divert the immune attack away from actual myelin. Dimethyl fumarate works by activating the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. Understanding these mechanisms helps patients and doctors choose the most appropriate therapy based on the disease's activity and the patient's specific needs.

Dimethyl fumarate for multiple sclerosis.