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Monoclonal Antibodies

Ofatumumab for Early Relapsing-Remitting Multiple Sclerosis (AGNOS 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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 to month 18 and 30
Awards & highlights

AGNOS 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.Check my eligibility
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.See study design
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.

AGNOS Trial Eligibility Criteria

Inclusion Criteria

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

AGNOS Trial 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

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
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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
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%
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%
Toxic skin eruption
3%
Renal failure acute
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%
Enterocolitis
1%
Pneumonia staphylococcal
1%
Urinary tract infection
1%
Pneumonia aspiration
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
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

AGNOS 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
~1470

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,537 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
51,959 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

Frequently Asked Questions

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

Does this trial include elderly individuals who are 85 and above?

"Patients between 18 and 35 years old are currently being sought for enrollment in this clinical trial."

Answered by AI

How many individuals are being surveyed in this medical experiment?

"Indeed, the information published by clinicaltrials.gov implies that this medical trial is actively enlisting patients. The study was initially advertised on January 25th 2022 and recently updated on August 5th 2022. It requires 168 participants from 4 different sites to be recruited."

Answered by AI

Has Ofatumumab been sanctioned by the United States Food and Drug Administration?

"Due to Ofatumumab's approval status, which is reflected by the Phase 4 trial designation, Power has assigned it a score of 3 on its safety scale."

Answered by AI

In what quantity of healthcare facilities is this experiment being executed?

"This trail is available at 4 centres, located in Phoenix, Altamonte Springs and Knoxville along with other locations. It may be beneficial to select the nearest medical facility if one wishes to reduce travel expenses associated with enrolment."

Answered by AI

Could you provide a summary of the outcomes from previous research into Ofatumumab?

"Currently, there are 23 active research projects studying Ofatumumab. 6 of them have advanced to Phase 3 trials. Most studies involving this treatment occur in Houston, Texas though it is also being tested in 749 other locales."

Answered by AI

Are there still openings for volunteers in this clinical trial?

"This clinical trial, which was first made available on January 25th 2022 and recently updated in August 5th of the same year, is actively recruiting patients as per information hosted at ClinicalTrials.gov."

Answered by AI

In what capacity is Ofatumumab typically prescribed?

"Ofatumumab is an effective course of treatment for multiple sclerosis and it also has been seen to have a positive effect on those with refractory fludarabine, ineligible for fludarabine-based therapy, and active secondary progressive multiple sclerosis (SPMS)."

Answered by AI

Is it possible for me to participate in this scientific investigation?

"Qualified applicants for this study must have a diagnosis of multiple sclerosis and fit between the age parameters of 18 to 35. Currently, 168 people are being enrolled as participants."

Answered by AI

Is this trial pioneering a new approach to treatment?

"Presently, 23 active experiments for Ofatumumab are being held in 290 cities spread across 45 nations. This biopharmaceutical began its testing journey back in 2010 with GlaxoSmithKline's Phase 2 study of 32 participants; since then, 72 trials have been conducted."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
2022. "Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05084638.
~47 spots leftby Feb 2025
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