What is the mechanism of action of this treatment?

Common treatments for Systemic Sclerosis (SSc) often focus on modulating the immune system, reducing inflammation, and preventing fibrosis. These treatments may include immunosuppressive drugs, anti-fibrotic agents, and biologics that target specific pathways involved in the disease process. For instance, RO7303509, currently under study, likely aims to address these mechanisms to improve patient outcomes. Understanding these mechanisms is important for SSc patients as it helps manage symptoms, slow disease progression, and enhance overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Systemic Sclerosis, particularly those involving immunosuppressive and immunomodulatory therapies similar to RO7303509, often have a range of side effects. These can include gastrointestinal issues such as nausea and diarrhea, liver enzyme elevation, and bone marrow suppression, which can lead to increased risk of infections. Other potential adverse effects include pancreatitis and elevated liver enzymes. Long-term use of these medications may also result in more serious complications, such as liver toxicity and increased risk of malignancies. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for systemic sclerosis, primarily focusing on managing symptoms and slowing disease progression. Notable drugs include immunosuppressive agents like mycophenolate mofetil and cyclophosphamide, which have shown efficacy in treating interstitial lung disease associated with systemic sclerosis. Additionally, biologics such as rituximab have been used off-label for systemic sclerosis due to their immunomodulatory effects. These treatments share similarities with RO7303509, which is being evaluated for its safety, tolerability, and pharmacokinetics in systemic sclerosis patients.

What other types of research exist?

Promising novel alternatives to RO7303509 for systemic sclerosis patients include nintedanib, an antifibrotic agent approved for SSc-related interstitial lung disease, and tocilizumab, an IL-6 receptor antagonist that has shown efficacy in SSc. Both have demonstrated safety and tolerability in clinical trials and offer new therapeutic options for SSc patients.

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Monoclonal Antibodies

RO7303509 for Systemic Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

Weight of 45-150 kg at screening

Be older than 18 years old

Must not have

Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy

Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called RO7303509 in people with systemic sclerosis. The study will give patients increasing doses of the drug to see how their bodies react and to make sure it is safe. The trial includes a treatment period followed by a safety check or an extended safety phase.

Who is the study for?

This trial is for adults weighing 45-150 kg with systemic sclerosis diagnosed within the last 10 years. They must not have severe lung, liver, kidney, heart or other major health issues and agree to use effective contraception. Excluded are those with significant pulmonary disease, positive tests for certain viruses like HIV or hepatitis B/C, recent or upcoming major surgery, pregnancy/breastfeeding women, and those with other active autoimmune diseases.

What is being tested?

The study is testing RO7303509's safety and how the body processes it in people with systemic sclerosis over a period of up to 65 weeks. Participants will receive increasing doses of RO7303509 or placebo during a first phase (12 weeks), followed by an optional long-term safety extension where everyone gets RO7303509.

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to immune system activation such as allergic responses due to the drug being a monoclonal antibody. Regular monitoring will assess any adverse effects on organ function and general health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 45 and 150 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am being treated for an autoimmune disease other than systemic sclerosis.

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My lung function is less than half of what it should be.

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I haven't had major surgery in the last 8 weeks and don't plan any during or within 3 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: OSE StageExperimental Treatment1 Intervention

Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year.

Group II: MAD StageExperimental Treatment2 Interventions

Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

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 Systemic Sclerosis (SSc) often focus on modulating the immune system, reducing inflammation, and preventing fibrosis. These treatments may include immunosuppressive drugs, anti-fibrotic agents, and biologics that target specific pathways involved in the disease process. For instance, RO7303509, currently under study, likely aims to address these mechanisms to improve patient outcomes. Understanding these mechanisms is important for SSc patients as it helps manage symptoms, slow disease progression, and enhance overall quality of life.

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