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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3 to15
Awards & highlights

SOSTOS Trial Summary

This trial will test whether relapsing-remitting MS patients who have not had a relapse in the past year would benefit from switching to ofatumumab, and whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from ofatumumab.

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.Check my eligibility
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.See study design
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.

SOSTOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
I have been on a disease-modifying therapy for my RRMS for at least 6 months.
Select...
I have not had a cancer relapse in the last 6 months.
Select...
I may have signs of my condition on an MRI, but it's not required for this trial.

SOSTOS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
Secondary outcome measures
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
21%
Neutropenia
18%
Infusion related reaction
14%
Cough
12%
Diarrhoea
12%
Fatigue
12%
Rash
11%
Nausea
11%
Asthenia
10%
Anaemia
10%
Paraesthesia
10%
Pyrexia
8%
Constipation
8%
Headache
8%
Upper respiratory tract infection
8%
Bronchitis
6%
Pruritus
6%
Vomiting
6%
Dyspnoea
6%
Thrombocytopenia
6%
Insomnia
6%
Paraesthesia oral
5%
Hypotension
5%
Back pain
5%
Muscle spasms
5%
Oedema peripheral
3%
Dizziness
3%
Arthralgia
3%
Hypertension
3%
Hyperkalaemia
3%
Pneumonia
3%
Abdominal pain upper
3%
Nasopharyngitis
3%
Decreased appetite
3%
Dyspepsia
2%
Febrile neutropenia
2%
Weight decreased
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Abdominal pain
2%
Hypokalaemia
2%
Rhinorrhoea
2%
Escherichia sepsis
2%
Respiratory tract infection
2%
Pain in extremity
1%
Rash maculo-papular
1%
Colitis
1%
Clostridium difficile infection
1%
Cardiac failure
1%
Productive cough
1%
Dehydration
1%
Neutropenic sepsis
1%
Sepsis
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Lymph node pain
1%
Atrial fibrillation
1%
Disease progression
1%
Cholecystitis
1%
Drug hypersensitivity
1%
Streptococcal bacteraemia
1%
Device related infection
1%
Herpes virus infection
1%
Ischaemic stroke
1%
Renal failure acute
1%
Angina pectoris
1%
Oesophageal ulcer
1%
Portal hypertensive gastropathy
1%
Infusion site extravasation
1%
Hepatic failure
1%
Contrast media allergy
1%
Pneumonia bacterial
1%
Escherichia urinary tract infection
1%
Pneumonia viral
1%
Gastroenteritis
1%
Fall
1%
Hyponatraemia
1%
Hypercalcaemia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Malignant melanoma
1%
Glioblastoma multiforme
1%
Malignant pleural effusion
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of lung
1%
Pulmonary embolism
1%
Laryngeal stenosis
1%
Peripheral embolism
1%
Dry mouth
1%
Tachycardia
1%
Enterocolitis
1%
Lower respiratory tract infection
1%
Chronic sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ofatumumab
Duvelisib

SOSTOS 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
~1470

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,853 Previous Clinical Trials
4,197,328 Total Patients Enrolled
99 Trials studying Multiple Sclerosis
51,723 Patients Enrolled for Multiple Sclerosis

Media Library

Disease modifying treatment (DMT) Clinical Trial Eligibility Overview. Trial Name: NCT05090371 — Phase 4
Multiple Sclerosis Research Study Groups: Ofatumumab, DMT continued therapy
Multiple Sclerosis Clinical Trial 2023: Disease modifying treatment (DMT) Highlights & Side Effects. Trial Name: NCT05090371 — Phase 4
Disease modifying treatment (DMT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090371 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include adult participants that meet the age criteria of 25 or older?

"This medical trial is searching for patients aged between 18 and 50. There are 46 studies recruiting minors, while 405 trials focus on adults that exceed the age of 65."

Answered by AI

Is there a history of Ofatumumab being studied in clinical trials?

"Ofatumumab was first studied at the National Institutes of Health Clinical Center in 2010, and since then there have been 72 completed trials. Currently 23 active studies are underway with many centered around Lubbock, Texas."

Answered by AI

Are new participants being accepted in this clinical trial?

"Clinicaltrials.gov has it on record that this clinical trial, which was initially posted on March 2nd 2022, is currently searching for candidates and its details were last updated October 10th 2022."

Answered by AI

How many people are partaking in this research experiment?

"Affirmative. The information on clinicaltrials.gov illustrates that this experiment is currently recruiting individuals. This research was first posted on March 2nd 2022 and updated lastly on October 10th 2022, with the aim of sourcing 150 subjects from 9 medical facilities."

Answered by AI

To what degree can Ofatumumab pose a threat to those receiving it?

"According to our assessment, ofatumumab's safety rating is 3 out of 3 as its approval status denotes multiple rounds of testing and data validation."

Answered by AI

Are there any locations in North America conducting the research study?

"Currently, this medical trial is running in 9 distinct locations, which include Lubbock, Birmingham and Cullman. To alleviate the need for travel, it is advantageous to select the closest site when enrolling as a study participant."

Answered by AI

Does this experiment represent a pioneering approach to research?

"Internationally, there are 23 ongoing clinical studies related to the drug Ofatumumab. The initial trial commenced a decade ago and was sponsored by GlaxoSmithKline; it involved 32 participants and concluded its Phase 2 assessment successfully. Since then, 72 similar trials have been conducted in 290 cities across 45 countries."

Answered by AI

Do I meet all the criterion to participate in this research initiative?

"The trial has 150 slots open for patients between the ages of 18-50 with multiple sclerosis in its acute relapsing stage."

Answered by AI

How is Ofatumumab commonly employed in medical treatment?

"Ofatumumab is the typical treatment for multiple sclerosis and has been seen to be useful in managing refractory cases, fludarabine-ineligible patients, and active secondary progressive multiple sclerosis (spms)."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New York
What site did they apply to?
Novartis Investigative Site
Bradenton Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~70 spots leftby Feb 2026