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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
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 belowSelect...
I am between 18 and 45 years old.
Select...
I have been diagnosed with relapsing-remitting MS according to the 2017 criteria.
Select...
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:Select...
My condition is progressively worsening without relapses.
Select...
My symptoms or MRI results are not caused by multiple sclerosis.
Select...
My brain or spinal cord issues are caused by another condition, not my current illness.
Select...
I have another active cancer.
Select...
I have a chronic immune system condition other than MS, being treated.
Select...
I do not have any active infections, including COVID-19, and I am not HIV positive.
Select...
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
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 moreSide effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452250%
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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Rash
11%
Abdominal pain
10%
Hypokalaemia
10%
Oedema peripheral
9%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Pruritus
7%
Arthralgia
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Urinary tract infection
1%
Pneumonia staphylococcal
1%
Rash erythematous
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Skin infection
1%
Streptococcal sepsis
1%
Accidental overdose
1%
Fungal oesophagitis
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
1%
Respiratory failure
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab
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
~1480
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.
Dimethyl fumarate for multiple sclerosis.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,893 Previous Clinical Trials
4,200,801 Total Patients Enrolled
105 Trials studying Multiple Sclerosis
51,688 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a disease-modifying therapy for my RRMS for at least 6 months.My symptoms or MRI results are not caused by multiple sclerosis.My brain or spinal cord issues are caused by another condition, not my current illness.I have symptoms or a diagnosis of PML.I have not had a cancer relapse in the last 6 months.I am between 18 and 45 years old.I have been diagnosed with relapsing-remitting MS according to the 2017 criteria.You are okay with wearing a specific device as described in the study plan.My disability level allows me to walk, at least with assistance.My condition is progressively worsening without relapses.I have another active cancer.I do not have any active infections, including COVID-19, and I am not HIV positive.I have a chronic immune system condition other than MS, being treated.I may have signs of my condition on an MRI, but it's not required for this trial.I haven't used experimental MS drugs in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Ofatumumab
- Group 2: DMT continued therapy
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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