What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include glatiramer acetate, dimethyl fumarate, and fingolimod. Glatiramer acetate can cause local injection site reactions and, less commonly, systemic reactions such as chest pain and palpitations. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and a potential decrease in lymphocyte counts. Fingolimod's side effects include headache, elevated liver enzymes, bradyarrhythmia, macular edema, and an increased risk of infections due to its immunomodulating effects. These treatments aim to reduce relapse rates and slow disease progression but come with varying side effect profiles that need to be managed under medical supervision.

What prior FDA approvals exist?

Several intravenous treatments for Multiple Sclerosis (MS) have received FDA approval. Alemtuzumab, an intravenous infusion, is approved for relapsing forms of MS, particularly for patients with highly active disease who have not responded to other DMTs. Natalizumab, another intravenous therapy, is approved for relapsing forms of MS and works by inhibiting immune cell migration into the brain and spinal cord. Ocrelizumab, also administered intravenously, is approved for both relapsing and primary progressive forms of MS. These treatments, like RO7121932, are designed to modify the disease course and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to RO7121932 for Multiple Sclerosis patients include: 1) Dimethyl fumarate (BG-12), which has shown significant reductions in relapse rates and new brain lesions in the DEFINE and CONFIRM trials. 2) Monoclonal antibodies such as daclizumab, which has new open-label data supporting its efficacy and safety profile. 3) Emerging oral agents and antisense oligonucleotides, which are in late Phase II and III trials and show potential as disease-modifying therapies.

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Monoclonal Antibodies

RO7121932 for Multiple Sclerosis

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1,2, 5, 8 for part 2; day 1, 2, 5, 8, 15, 22, 29, 36 for part 3

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RO7121932 to see if it is safe and well-tolerated. The drug is being given to people with multiple sclerosis (MS) in different ways, either through a vein or under the skin. The goal is to find out if the drug can help treat MS without causing harmful side effects.

Who is the study for?

This trial is for adults with multiple sclerosis (MS) who haven't used any approved MS treatments at screening and won't start during the study. They should have an EDSS score ≤7.0, meet McDonald 2017 criteria for MS diagnosis, and use contraception if female. Excluded are those with recent MS activity, other neurological disorders that mimic MS, active infections including COVID-19 within 6 weeks prior to Day 1, history of cancer in the last 10 years (except certain skin cancers), or a history of severe allergies to biologic agents.

What is being tested?

The trial is testing RO7121932 given through IV to see how safe it is and how well participants with MS tolerate it. The focus is on single ascending doses to determine reactions and body processing.

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar trials may include injection site reactions, flu-like symptoms such as fever or chills, potential allergic reactions, fatigue, headache or possible changes in liver function tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1,2, 5, 8 for part 2; day 1, 2, 5, 8, 15, 22, 29, 36 for part 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1,2, 5, 8 for part 2; day 1, 2, 5, 8, 15, 22, 29, 36 for part 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1,2, 5, 8 for part 2; day 1, 2, 5, 8, 15, 22, 29, 36 for part 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1, Part 2 and Part 3: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Part 2 and Part 3: Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)

Part 2 and Part 3: Percentage of Participants with Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3Experimental Treatment1 Intervention

Participants will receive multiple SC doses of RO7121932, once weekly on treatment Day 1 through Day 22. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 700 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.

Group II: Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2Experimental Treatment1 Intervention

Participants will receive a single SC dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 200 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.

Group III: Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 6 and Later CohortsExperimental Treatment1 Intervention

Participants will receive a single IV dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 7 milligrams (mg) and will be escalated up to 2000 mg. The maximum dose will not exceed 4000 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) such as beta interferons, glatiramer acetate, and monoclonal antibodies like natalizumab and ocrelizumab work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath of nerve cells. This is crucial for MS patients as it helps to reduce the frequency and severity of relapses, slow disease progression, and manage symptoms, thereby improving their quality of life.

Mode of action and clinical studies with alemtuzumab.