RAY121 for Antiphospholipid Syndrome

Recruiting at 53 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Must be taking: RAY121

Disqualifiers: Infection, Pregnancy, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

Research Team

Sponsor Chugai Pharmaceutical Co.Ltd

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for patients with certain immune diseases like lupus and ITP who've had positive responses to RAY121 in a previous study. They must be able to follow the trial's rules, have signed consent, and agree to use contraception or abstain from sex.

Inclusion Criteria

I have signed the informed consent form.

I can follow the study's requirements as judged by the researcher.

I agree to avoid pregnancy during and for 20 weeks after my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of RAY121

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Long-term extension trial of RAY121 in patients with immunological diseases

Long-term

Treatment Details

Interventions

• RAY121

Trial Overview The RAINBOW-LTE Trial is testing the long-term effects of a drug called RAY121 on various immunological conditions such as APS, BP, BS, DM, IMNM, and ITP.

Participant Groups

Group I: RAY121 Experimental Treatment 1 Intervention

All enrolled patients will receive RAY121 multiple dose

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University