Exploratory Evaluation of Novel Investigational Eye Movement Biomarkers to Track Ofatumumab Treatment Response in Canadian Patients With Active Relapsing-Remitting Multiple Sclerosis (ELIOS)

Plain English Summary

ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS is a Phase 4 clinical trial sponsored by Novartis Pharmaceuticals studying Relapsing Remitting Multiple Sclerosis (RRMS). This study tests a new way to track how well a multiple sclerosis (MS) medication, ofatumumab, is working by measuring eye movements. It is for adults in Canada with active relapsing-remitting MS who are about to start treatment with ofatumumab. Participants will use a special eye-tracking device and provide blood samples. The alternative is standard monitoring of MS progression through doctor visits and imaging. The trial aims to enroll 224 participants.

Official Summary

The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults in Canada diagnosed with active relapsing-remitting MS. Must be prescribed ofatumumab but have not yet received their first dose. EDSS score between 0 and 7, indicating mild to moderate disability. Must be able to provide blood samples and understand English or French. This trial is studying Relapsing Remitting Multiple Sclerosis (RRMS), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how eye movement patterns change over 6 months, indicating how well the ofatumumab treatment is affecting the disease. The specific primary outcome measures are: 1- Change Eye Movement Biomarkers (EMB) (6 months from baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial matters because it seeks to find a more precise and potentially earlier way to measure the effectiveness of MS treatments by using eye movement patterns, filling a gap in current monitoring This research targets Relapsing Remitting Multiple Sclerosis (RRMS), where improved treatment options are needed.

Investor Insight

This trial signals Novartis's investment in innovative digital health tools for MS, potentially creating a new market for AI-driven diagnostic and monitoring solutions in neurology. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what the potential benefits and risks are. You will use an eye-tracking device to perform specific visual tasks. You will need to provide blood samples and attend regular study visits. This trial is currently recruiting participants. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 224 participants

Interventions

• DEVICE: ETNATM-ProgMS — To that end, the study will use the patented investigational ETNATM-ProgMS SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision. Of note, investigational versions of this SaMD are used for the purpose of clinical research only and will not be commercialized.

Primary Outcomes

• 1- Change Eye Movement Biomarkers (EMB) (6 months from baseline)

Secondary Outcomes

• 1a. Change in EMB (3,12 and 24 months from Baseline)
• 1b. Change in EMB trajectories (3-, 6-, 12-, and 24-months)
• 2a. Change in Annual Relapse Rate (ARR) (12 and 24 months from baseline)
• 2b. Change in patient disability measured by Expanded Disability Status Scale EDSS (3,6,12,24 months from baseline)
• 2b. Change in patient disability measured by Timed 25-foot walk test (T25-FW) (3,6,12,24 months from baseline)

Full Eligibility Criteria

Inclusion criteria

Patients eligible for inclusion in the study must fulfill all of the following criteria:

1. Adult patients who are prescribed ofatumumab as part of routine clinical care as per the PM but who have not yet received their first dose. The decision to prescribe ofatumumab must be made prior to and independent of study participation.
2. Patients or their legally authorized representatives who sign the Institutional Review Boards/Independent Ethics Committee (IRB/IEC)-approved informed consent form.
3. Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment.
4. Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2.
5. Patients who can provide blood samples.
6. Patients who can understand written and spoken Canadian English or French.
7. Patients who have sufficient corrected visual acuity to allow for accurate reading of the on-screen visual task instructions, in the judgement of the Investigator. If a relapse temporarily affects a patient's corrected visual acuity, the Baseline Visit may be postponed until the patient can accurately read the on-screen visual task instructions, if deemed acceptable by the Investigator and the patient.
8. Patients with a confirmed diagnosis of MS with no signs of progressive increase in physical disability independent of relapse activity within the past six months, as assessed by a physician.

Exclusion criteria

In order to ensure that the study population will be representative of all eligible patients, no additional exclusions may be applied by the Investigator. Patients meeting any of the following criteria are not eligible for inclusion in this study:

1. Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome.
2. Any disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
3. Pregnant or nursing (lactating) women.
4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while taking ofatumumab and for six months after stopping medication. Effective contraception methods include:

   * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
   * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to enrollment. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow-up hormone level assessment
   * Male sterilization at least six months prior to enrollment. For female participants on the study, the vasectomized male partner should be the sole partner for that participant
   * Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%) such as hormone vaginal ring or transdermal hormone contraception
   * Use of barrier methods of contraception (male or female condom, occlusive cap, diaphragm or cervical/vault caps)
   * In case of use of hormonal contraception women participants should have been stable on the same method for a minimum of three months before taking study treatment.
   * If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.
   * Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women participants are considered not of child-bearing potential if they are post-menopausal or have had bilateral tubal ligation, surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment on study. In the case of oophorectomy alone, a woman is not considered to be of child-bearing potential only when the reproductive status has been confirmed by follow-up hormone level assessment.
5. Patients with hypersensitivity to ofatumumab or to any ingredient in the formulation, active hepatitis B virus, progressive multifocal leukoencephalopathy (PML), severe active infections, in a severely immunocompromised state or with known active malignancies.
6. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, sc

Trial Locations

• Novartis Investigative Site, Calgary, Alberta, Canada
• Novartis Investigative Site, Calgary, Alberta, Canada
• Novartis Investigative Site, Edmonton, Alberta, Canada
• Novartis Investigative Site, Burnaby, British Columbia, Canada
• Novartis Investigative Site, Vancouver, British Columbia, Canada
• Novartis Investigative Site, St. John's, Newfoundland and Labrador, Canada
• Novartis Investigative Site, Halifax, Nova Scotia, Canada
• Novartis Investigative Site, Halifax, Nova Scotia, Canada
• Novartis Investigative Site, Ottawa, Ontario, Canada
• Novartis Investigative Site, Montreal, Quebec, Canada
• ...and 4 more locations

Frequently Asked Questions

Related Conditions

• Multiple Sclerosis (MS)
• Relapsing-Remitting Multiple Sclerosis (RRMS)
• Neurological Disorders
• Autoimmune Diseases
• Neuroinflammation
• Central Nervous System Diseases
• Immunomodulatory Therapy
• Biomarker Discovery
• Digital Health
• Ophthalmology

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