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Complement Pathway Inhibitor

RAY121 for Dermatomyositis

Phase 1

Waitlist Available

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

Study Summary

This trial will test the safety and effectiveness of a drug called RAY121 in patients with immune-related diseases such as APS, BP, BS, DM, IMNM, and ITP. The trial

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events (AEs)

Secondary outcome measures

AUCτ

Active C1s

Anti-RAY121 antibodies

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: RAY121Experimental Treatment1 Intervention

All enrolled patients will receive RAY121 multiple dose

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor

95 Previous Clinical Trials

21,560 Total Patients Enrolled

Sponsor Chugai Pharmaceutical Co.LtdStudy Directorclinical-trials@chugai-pharm.co.jp

1 Previous Clinical Trials

219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to participate in this ongoing medical study?

"As per the details on clinicaltrials.gov, recruitment for this particular medical trial is currently paused. The study was first listed on May 31st, 2024 and last updated on April 14th, 2024. Despite the inactive status of this trial, there are a total of 1689 other ongoing studies actively seeking participants."

Answered by AI

Has RAY121 received approval from the FDA?

"Based on our evaluation at Power, the safety rating for RAY121 is 1 due to its Phase 1 status, indicating minimal supporting data for both safety and efficacy."

Answered by AI

Is the age limit for participation in this medical study set above 30 years of age?

"Individuals aged between 18 and 85 are eligible to participate in this clinical trial. It is noted that there are a substantial number of trials available for those younger than 18 years old as well as individuals over the age of 65, with figures standing at approximately 431 and 1226, respectively."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"The current investigation is operational at 6 sites, with key centers in Sapporo, Sendai, and Suita alongside additional locations. Opting for the closest site can reduce travel burdens upon enrollment."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this research study?

"To be considered for participation in this research, patients must have antiphospholipid syndrome and fall between the ages of 18 to 85. The trial aims to recruit a total of 144 eligible individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

2024. "Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06371417.

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