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Monoclonal Antibodies
Ofatumumab for Relapsing Multiple Sclerosis (OLIKOS Trial)
Phase 3
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
Male or female participants aged 18 to 60 years (inclusive) at screening
Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 and 12 months
Awards & highlights
OLIKOS Trial Summary
This trial is testing if a medication called ofatumumab is effective, safe, and tolerated in patients with relapsing multiple sclerosis who are transitioning from a different medication.
Who is the study for?
This trial is for adults aged 18-60 with relapsing multiple sclerosis, who were previously on aCD20 therapy and are neurologically stable. They must have had at least two courses of the prior treatment and be able to use a smart device or have help from a caregiver. Pregnant women, those not using effective contraception, or individuals with certain infections or immune conditions cannot participate.Check my eligibility
What is being tested?
The study tests Ofatumumab's effectiveness and safety in patients transitioning from another monoclonal antibody therapy for relapsing multiple sclerosis. It's a single-arm trial where all participants receive Ofatumumab without comparison to another drug or placebo.See study design
What are the potential side effects?
Ofatumumab may cause side effects such as infusion reactions (symptoms that can occur during or after the drug is given), increased risk of infections due to its impact on the immune system, and possibly other symptoms related to changes in blood cell counts.
OLIKOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
My disability level allows me to walk without aid or rest for 200 meters.
Select...
I have received at least 2 rounds of IV therapy targeting CD20.
Select...
I am between 18 and 60 years old.
Select...
I have been diagnosed with relapsing MS as per the 2017 criteria.
OLIKOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with no change or reduction in gadolinium enhancing lesions at 12 months
Secondary outcome measures
Change from baseline for CD3+CD20+ T cell counts
Change from baseline for Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Change from baseline for total CD19+ B cell counts and CD3+CD20+ T cell counts
+2 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%
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%
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%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Proctitis
1%
Pneumonia staphylococcal
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
OLIKOS Trial Design
1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment1 Intervention
Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml) administered at baseline, Day 7, Day 14 and monthly thereafter
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
2,855 Previous Clinical Trials
4,197,239 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
52,016 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.I have been diagnosed with neuromyelitis optica.I am not using highly effective birth control methods.My MS is either primary progressive or secondary progressive without recent activity.My neurological condition has been stable for the last month.If you stopped taking aCD20 therapy for any reason or if your neurological condition has been stable for at least 1 month before starting the study, you can participate.I have symptoms or a confirmed diagnosis of PML.I have received rituximab doses on day 1 and 15, and follow-up doses every 6 months.My disability level allows me to walk without aid or rest for 200 meters.I do not have any active infections or AIDS.I have a chronic disease or immune system issue, but it's not MS.I received my last full dose of rituximab between 4 to 9 months ago.My previous treatment with aCD20 therapy didn't work well.I have received at least 2 rounds of IV therapy targeting CD20.I stopped taking aCD20 therapy for certain reasons.I am at risk for syphilis, tuberculosis, or hepatitis.I stopped aCD20 therapy due to bad reactions, infections, or low IgG needing IV treatment.I have not received any live vaccines in the last 4 weeks.I am between 18 and 60 years old.I have been diagnosed with relapsing MS as per the 2017 criteria.You must be able to use a smart device or have a caregiver that can assist.
Research Study Groups:
This trial has the following groups:- Group 1: Ofatumumab
Awards:
This trial has 2 awards, including:- 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.
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.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT04486716 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary indications of Ofatumumab?
"Patients with multiple sclerosis who have not responded to fludarabine or alemtuzumab, and are ineligible for fludarabine-based therapy, can be treated using Ofatumumab."
Answered by AI
What is the historical context of this clinical trial?
"GlaxoSmithKline first sponsored a trial for Ofatumumab in 2011. Since the first Phase 2 trial, which had 44 participants, there have been 22 different active trials in 289 cities and 45 countries."
Answered by AI
How many people are being enrolled to this clinical trial?
"That is accurate. The clinical trial in question, which is detailed on clinicaltrials.gov, is recruiting patients at this time. The study was first posted on October 19th 2020 and was updated as recently as March 22nd 2022. They are hoping to find 100 patients total, with 15 different locations taking part in the trial."
Answered by AI
Are elderly patients able to enroll in this research project?
"This clinical trial is only open to patients aged 18-60."
Answered by AI
What is the historical efficacy of Ofatumumab?
"Ofatumumab was first researched in 2011 at University of Texas MD Anderson Cancer Center. In the last decade, there have been a total of 72 completed trials. Out of these, 22 are currently recruiting patients. A majority of these studies are based in Las Vegas, Nevada."
Answered by AI
Can anyone sign up for this research project at this time?
"This clinical trial is still recruiting participants, according to the latest update on clinicaltrials.gov. The trial was first posted on October 19th 2020, and the most recent update was on March 22nd 2022."
Answered by AI
What is the status of Ofatumumab's journey through the FDA?
"There is both animal and human data supporting ofatumumab's efficacy, making it a 3 on our safety scale."
Answered by AI
Are there any hospitals in North America conducting this study?
"To participate in this trial, you must be able to visit one of the 15 sites. These locations are situated in Las Vegas, Wellesley, Westerville and a dozen other cities. To cut down on travel costs and time, please choose the site that is closest to you."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am on Ocrevus but have noticed to difference in my severe pain.
PatientReceived no prior treatments
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