RAY121 for Antiphospholipid Syndrome

Enrolling by invitation at 63 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called RAY121 for individuals with certain immune system diseases, including antiphospholipid syndrome (APS). The goal is to assess the long-term effectiveness of RAY121 by observing its effects on participants who previously responded well to it. Participants will continue receiving RAY121 to monitor its safety and effectiveness over time. Those who completed a previous study with RAY121 and responded positively may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this promising treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that RAY121 is likely to be safe for humans?

Previous studies have tested RAY121 for safety in people with various immune-related conditions. Research shows that RAY121 is being evaluated for tolerability and potential side effects. Although these studies remain in the early stages, they are crucial for ensuring the treatment's safety.

In this early-phase trial, the primary focus is on understanding safety. Researchers closely monitor RAY121 to observe participants' reactions. Early phases like this are essential for identifying any issues.

If the FDA had already approved RAY121 for other conditions, it would suggest some level of safety. However, more information is needed to fully confirm its safety. Participants are monitored throughout the trial for any adverse effects, which helps ensure everyone's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for antiphospholipid syndrome?

Unlike the standard treatments for Antiphospholipid Syndrome, which often include anticoagulants like warfarin and heparin, RAY121 is unique because it targets the condition with a novel mechanism of action. Researchers are excited about RAY121 as it potentially offers a more direct approach to managing the syndrome by specifically interfering with the pathways involved in the formation of harmful blood clots. This could lead to improved outcomes for patients who do not respond well to existing therapies.

What evidence suggests that RAY121 might be an effective treatment for antiphospholipid syndrome?

Studies have shown that RAY121 is under development to treat autoimmune diseases such as antiphospholipid syndrome (APS). Early results suggest that RAY121 might help control the immune system, potentially reducing the harmful effects of APS. Researchers are investigating the safety and mechanism of RAY121, with initial data indicating it might help manage APS symptoms. Although detailed human data remains limited, the mechanism of RAY121 shows promise in addressing immune system issues common in these diseases. ^{1 4 5 6 7}

Who Is on the Research Team?

Sponsor Chugai Pharmaceutical Co.Ltd

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06723106

Phase 1b Long-term Extension Trial of RAY121 in ... This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/487595

Phase 1b Trial of RAY121 in Immunological Diseases ... This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary ...

3. globaldata.com globaldata.com/store/report/ray-121-in-antiphospholipid-syndrome-loa-innovation-and-trend-analysis/

Likelihood of Approval and Phase Transition Success Rate ... RAY-121 is under development for the treatment of autoimmune disease, unspecified central nervous system disorders, antiphospholipid syndrome ( ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-1b-ray121-immunological-diseases-rainbow-trial-nct06371417

A Phase 1b Trial of RAY121 in Immunological Diseases Additionally, the study aims to gather preliminary data on the potential effectiveness of RAY121 in treating conditions such as antiphospholipid syndrome ...

5. withpower.com withpower.com/trial/phase-1-pemphigoid-bullous-11-2024-5032b

RAY121 for Antiphospholipid Syndrome · Info for Participants This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06371417

Study Details | NCT06371417 | Phase 1b Trial of RAY121 ... This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT06371417

Phase 1b Trial of RAY121 in Immunological Diseases ... This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a ...