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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
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 moreAwards & 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
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.
Treatment of Calcinosis in Juvenile Dermatomyositis.Inflammatory myopathies: clinical, diagnostic and therapeutic aspects.
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Who is running the clinical trial?
Chugai PharmaceuticalLead Sponsor
98 Previous Clinical Trials
22,444 Total Patients Enrolled
1 Trials studying Antiphospholipid Syndrome
144 Patients Enrolled for Antiphospholipid Syndrome
Sponsor Chugai Pharmaceutical Co.LtdStudy Directorclinical-trials@chugai-pharm.co.jp
2 Previous Clinical Trials
363 Total Patients Enrolled
1 Trials studying Antiphospholipid Syndrome
144 Patients Enrolled for Antiphospholipid Syndrome