RO7121932 for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Hoffmann-La Roche

Must not be taking: MS treatments, Anti-CD20 therapies

Disqualifiers: Active infections, Cancer history, Neurological disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants are not on any approved MS treatment at the time of screening and do not plan to start any MS therapy during the study. If you are currently on an MS treatment, you may need to complete a washout period (time without taking the medication) before joining the trial.

How is the drug RO7121932 different from other treatments for multiple sclerosis?

The drug RO7121932 is unique because it may offer a novel mechanism of action or administration compared to existing treatments like glatiramer acetate, which is a synthetic amino acid polymer, or TAK-828F, which targets specific immune cells. However, specific details about RO7121932's mechanism or administration are not provided in the available research. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I am using birth control or practicing abstinence.

My disability level allows me to at least partially walk.

I have been diagnosed with RMS or PMS according to the McDonald 2017 criteria.

Exclusion Criteria

I do not have any major health issues apart from my current condition.

I have no history of major spine issues that would prevent a lumbar puncture.

I have a neurological condition that is not MS, such as Lyme disease or Vitamin B12 deficiency.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single ascending intravenous (IV) dose of RO7121932

24 weeks

Multiple visits for dose escalation and monitoring

Treatment Part 2

Participants receive a single ascending subcutaneous (SC) dose of RO7121932

24 weeks

Multiple visits for dose escalation and monitoring

Treatment Part 3

Participants receive multiple ascending subcutaneous (SC) doses of RO7121932

28 weeks

Weekly visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RO7121932 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 Cohorts Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Glatiramer acetate has shown partial efficacy in reducing relapse rates and improving clinical outcomes in patients with relapsing-remitting multiple sclerosis (RR MS), but it does not significantly affect sustained disease progression.

The treatment is not effective for patients with progressive multiple sclerosis (P MS), and while it has a favorable safety profile, common side effects include injection-site reactions and transient systemic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glatiramer acetate for multiple sclerosis. La Mantia, L., Munari, LM., Lovati, R.[2022]

RTL1000, a human recombinant T cell receptor ligand, was found to be safe and well tolerated in a Phase 1 study involving 34 subjects with multiple sclerosis, even at doses up to 200 mg.

This treatment showed potential for reversing clinical and histological signs of experimental autoimmune encephalomyelitis (EAE), suggesting it could offer a new way to manage MS without causing global immunosuppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RTL therapy for multiple sclerosis: a Phase I clinical study. Offner, H., Sinha, S., Burrows, GG., et al.[2022]

A 31-year-old woman developed severe acute hepatitis after starting glatiramer acetate for multiple sclerosis, indicating a potential risk of liver toxicity associated with this treatment.

Liver function tests normalized within two months after stopping glatiramer acetate, suggesting that the liver damage was reversible upon discontinuation of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glatiramer acetate induced hepatotoxicity. Subramaniam, K., Pavli, P., Llewellyn, H., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Glatiramer acetate for multiple sclerosis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of vitamin A supplementation on retinoic acid-related orphan receptor γt (RORγt) and interleukin-17 (IL-17) gene expression in Avonex-treated multiple sclerotic patients. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

RTL therapy for multiple sclerosis: a Phase I clinical study. [2022]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Glatiramer acetate induced hepatotoxicity. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmacological evaluation of TAK-828F, a novel orally available RORγt inverse agonist, on murine chronic experimental autoimmune encephalomyelitis model. [2020]