Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) (NCT06371417) | Clinical Trial Compass
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
United States, Australia, Austria144 participantsStarted 2024-08-19
Plain-language summary
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration 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).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form
. Age \>= 18 and \<=75 at the time of signing informed consent form (except for BP; Age \>=18 and \<= 85 with Karnofsky score \>= 60% at screening)
. Ability to comply with the study protocol
. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods
. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1b trial called the RAINBOW Trial, and its main goal is to measure adverse events rather than whether RAY121 works, what does that mean for my personal safety, and how does that change the risk-benefit calculation compared to my current treatment options?
2RAY121 is being tested across six very different immune conditions — including my diagnosis — so can you explain why one drug is being studied for all of them, and what that might tell us about how RAY121 is thought to work in my specific disease?
3Because this is early-phase research focused on safety monitoring, how will my health be tracked during the trial, and what happens if I experience a serious side effect or my condition gets worse while I'm enrolled?
4Given that this trial is still in Phase 1b and standard treatments already exist for my condition, would it make more sense to try established therapies first before considering an experimental drug like RAY121?
5What are the practical demands of participating in the RAINBOW Trial — things like how often I'd need to come in for visits, whether there are travel requirements, and how it might affect my day-to-day life or other medications I'm taking?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of anaphylaxis or hypersensitivity to a biologic agent
. Active infection requiring systemic antiviral, antibiotics or antifungal
. Planned surgery during the study
. Pregnant or breastfeeding, or intending to become pregnant
. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study
. Clinically significant ECG abnormalities
. Illicit drug or alcohol abuse
. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)