ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS

NCT06733922 | Recruiting Phase 4

• 1 other identifier: COMB157GCA05
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

Ofatumumab; Eye Movement Biomarkers (EMB); Patient-Reported Outcomes (PRO); Active Relapsing-Remitting MS (RRMS); Real-World, Neurofilament Light Chain (NfL); Digital, Eye-Tracking

Outcome Measures

Primary Outcomes (1)

• 1- Change Eye Movement Biomarkers (EMB)

  Change in subtle eye movement anomalies referred to as Eye Movement Biomarkers (EMBs). EMB are derived from composite scores of various Eye Movement metrics. Results stratified by patients experiencing a clinically meaningful change (CMC) in at least one traditional MS outcome (CMCp) or no CMC in all traditional MS outcomes (CMCs/i) at 24 months (or at the time of ofatumumab discontinuation and treated with ofatumumab for at least 12 months)

  6 months from baseline

Secondary Outcomes (19)

• 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

Study Arms (1)

ETNATM-ProgMS

EXPERIMENTAL

Patients with active RRMS being prescribed ofatumumab as part of routine clinical care will have their eye movements reliably and accurately tracked using ETNATM-ProgMS SaMD (v1.0.11 or later) at baseline, 3-, 6-, 12-, and 24-months following ofatumumab initiation

Device: ETNATM-ProgMS

Interventions

ETNATM-ProgMS DEVICE

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.

ETNATM-ProgMS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients or their legally authorized representatives who sign the Institutional Review Boards/Independent Ethics Committee (IRB/IEC)-approved informed consent form.
• Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment.
• Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2.
• Patients who can provide blood samples.
• Patients who can understand written and spoken Canadian English or French.
• 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.
• 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.

You may not qualify if:

• Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome.
• 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.
• Pregnant or nursing (lactating) women.
• 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.
• 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.
• Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).
• Patients who are using other investigational drugs within 30 days prior to or at the Baseline Visit, or within a period corresponding to five elimination half-lives, whichever is longer, or who are using other investigational drugs for which the expected pharmacodynamic effect has not returned to baseline.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigative Site

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

Novartis Investigative Site

Calgary, Alberta, T3M 1M4, Canada

RECRUITING

Novartis Investigative Site

Edmonton, Alberta, T6G 2C8, Canada

RECRUITING

Novartis Investigative Site

Burnaby, British Columbia, V5G 2X6, Canada

RECRUITING

Novartis Investigative Site

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Novartis Investigative Site

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Novartis Investigative Site

Halifax, Nova Scotia, B3R 1V9, Canada

RECRUITING

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H1K 3V9, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H3A 0G4, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Novartis Investigative Site

Québec, Quebec, G1W 4R4, Canada

RECRUITING

Novartis Investigative Site

Sherbrooke, Quebec, J1G 2E8, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Study Director

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase IV, interventional, multi-center, single-arm, open-label, exploratory, descriptive study conducted across geographical regions of Canada 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 initiating ofatumumab.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 13, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (14)