What side effects are associated with this type of intervention?

Common treatments for Dermatomyositis include glucocorticoids, which can cause weight gain, hypertension, diabetes, and osteoporosis. Mycophenolate mofetil may lead to gastrointestinal issues and increased risk of infections. Calcineurin inhibitors like cyclosporine and tacrolimus can cause nephrotoxicity, hypertension, and hyperglycemia. Biologics such as rituximab and tocilizumab are associated with infusion reactions, infections, and potential development of antibodies against the drugs. These treatments aim to modulate the immune system, similar to the mechanism of the classical complement pathway inhibitor studied in the RAY121 trial.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments targeting the classical complement pathway in dermatomyositis within the provided context. However, treatments for dermatomyositis often include immunosuppressive agents such as methotrexate, azathioprine, and mycophenolate mofetil, as well as biologics like rituximab. These treatments aim to modulate the immune response, similar to the investigational approach of RAY121.

What other types of research exist?

Promising alternatives to RAY121 for Dermatomyositis patients include eculizumab, a terminal complement inhibitor shown to improve symptoms in myasthenia gravis, and tofacitinib, a Janus kinase inhibitor that has shown potential in treating rapidly progressive interstitial lung disease in anti-MDA5 antibody-positive clinically amyopathic dermatomyositis. Additionally, mycophenolate mofetil has been suggested as a second-line agent for resistant dermatomyositis.

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Complement Pathway Inhibitor

RAY121 for Immune System Disorders

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

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 baseline to week 32

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RAY121, which aims to help people with certain immune system diseases by blocking a part of the immune system that causes inflammation. The trial will check if the drug is safe and effective for patients with conditions like APS, BP, BS, DM, IMNM, and ITP.

Who is the study for?

This trial is for people with certain immune system disorders like low platelet count, antiphospholipid syndrome, dermatomyositis, Behcet's Disease, and bullous pemphigoid. Participants should have one of these conditions to join the study.

What is being tested?

The RAINBOW Trial is testing a new medication called RAY121 to see if it's safe and how well it works in treating various immunological diseases by inhibiting part of the body's immune response.

What are the potential side effects?

Possible side effects include reactions related to the immune system since RAY121 affects its function. Specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 32 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events (AEs)

Secondary study objectives

AUCτ

Active C1s

Anti-RAY121 antibodies

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: RAY121Experimental Treatment1 Intervention

All enrolled patients will receive RAY121 multiple dose

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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

The most common treatments for Dermatomyositis (DM) include immunosuppressive agents like glucocorticoids, methotrexate, and mycophenolate mofetil, as well as immunomodulatory therapies such as intravenous immunoglobulin (IVIG). These treatments work by reducing inflammation and suppressing the immune system's abnormal attack on muscle and skin tissues. For instance, glucocorticoids inhibit multiple inflammatory pathways, while methotrexate and mycophenolate mofetil interfere with DNA synthesis in immune cells, reducing their proliferation. IVIG provides a broad immunomodulatory effect by neutralizing autoantibodies and modulating immune cell function. The relevance of these mechanisms lies in their ability to alleviate muscle weakness, skin rashes, and other systemic symptoms of DM, thereby improving patient quality of life. Treatments like RAY121, which inhibit the classical complement pathway, are particularly promising as they target specific components of the immune response, potentially offering more precise and effective control of the disease with fewer side effects.

Treatment of Calcinosis in Juvenile Dermatomyositis.Inflammatory myopathies: clinical, diagnostic and therapeutic aspects.