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Monoclonal Antibodies

Ofatumumab for Early Relapsing-Remitting Multiple Sclerosis (AGNOS Trial)

Phase 4
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients in the ofatumumab-treated arm must be treatment-naïve to MS DMT
Patients in the ofatumumab-treated arm must have a diagnosis of RRMS per McDonald Criteria (2010/2017)
Must not have
RRMS patients with known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
RRMS patients using experimental or investigational drugs for MS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 to month 18 and 30
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the effects of ofatumumab in people with RRMS who are in the early stages of the disease. The study will use clinical and MRI outcomes to track changes in the disease, as well as digital devices, biomarkers, and non-conventional MRI. The results of the ofatumumab group will be compared to a group of healthy people to see if there are any similarities between the two groups after treatment.

Who is the study for?
This trial is for young adults aged 18-35 with very early Relapsing Remitting Multiple Sclerosis (RRMS), diagnosed within the last 6 months and who haven't started any MS treatments. Participants must be able to use a wearable device, provide blood samples, and undergo MRI scans. Pregnant women, those with other immune diseases or infections, previous MS treatments, or severe kidney issues can't join.
What is being tested?
The study tests Ofatumumab's effects on new RRMS patients by comparing clinical outcomes and MRI results before and after treatment. It also uses digital monitoring and biomarker analysis to track changes in disease progression against healthy controls without MS.
What are the potential side effects?
Ofatumumab may cause injection site reactions, infections due to lowered immunity, headache, feverish symptoms like chills or night sweats. There might also be risks associated with frequent blood draws and potential allergic reactions to MRI contrast agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received any MS disease-modifying treatments before.
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I have been diagnosed with relapsing-remitting MS according to the McDonald Criteria.
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My disability level is low to moderate.
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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to some medications or their ingredients used in this study.
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I am using experimental drugs for my multiple sclerosis.
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I have RRMS and experienced a relapse recently.
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I have RRMS and am allergic to gadolinium or have severe kidney disease.
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I have RRMS and a currently active cancer.
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I am pregnant or nursing and have RRMS.
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I do not have any active infections or HIV/AIDS.
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I have RRMS and show signs of or have been diagnosed with PML.
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I have RRMS and do not have neuromyelitis optica or any form of progressive MS.
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I have RRMS and another active chronic immune disease or immunodeficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 to month 18 and 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 to month 18 and 30 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
Brain volume loss (BVL) assessment (whole brain and regional)
Change from Baseline for NeuroQOL
Change from Baseline for Patient Determined Disease Steps (PDDS)
+9 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
9%
Aspartate aminotransferase increased
9%
Dyspnoea
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
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%
Respiratory failure
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Urinary tract infection
1%
Pneumonia staphylococcal
1%
Pleural haemorrhage
1%
Streptococcal sepsis
1%
Skin infection
1%
Rash erythematous
1%
Accidental overdose
1%
Fungal oesophagitis
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
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

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OfatumumabExperimental Treatment1 Intervention
Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30.
Group II: Healthy ControlActive Control1 Intervention
Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,909 Previous Clinical Trials
4,209,893 Total Patients Enrolled
107 Trials studying Multiple Sclerosis
51,612 Patients Enrolled for Multiple Sclerosis

Media Library

Ofatumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05084638 — Phase 4
Multiple Sclerosis Research Study Groups: Ofatumumab, Healthy Control
Multiple Sclerosis Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT05084638 — Phase 4
Ofatumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084638 — Phase 4
~10 spots leftby Feb 2025
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