Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
The RAINBOW-LTE trial is a long-term study for people who have already benefited from a treatment called RAY121 in a previous study. RAY121 is being looked at for various immune conditions, including Antiphospholipid Syndrome (which can affect blood clotting), Bullous Pemphigoid (a skin blistering disease), Behçet's Syndrome (causing inflammation in various parts of the body), Dermatomyositis and Immune-mediated Necrotizing Myopathy (both affecting muscles), and Immune Thrombocytopenia (a blood condition). This study aims to understand how safe and effective RAY121 is over a longer period. It's for adults aged 18 to 85 who have shown positive responses to RAY121 before. The goal is to gather more information about this potential new treatment.
At a glance
What is this study about?
This study is called the RAINBOW-LTE Trial, and it's looking at a medicine called RAY121. The main purpose of this particular study is to follow up with people who have already taken part in an earlier study of RAY121 and found it helpful. It's like continuing to check in with them to see how they're doing with the treatment over a longer period.
The conditions being looked at in this study are all what we call 'immunological diseases'. This means they are conditions where a person's immune system, which normally fights off infections, mistakenly attacks healthy parts of their own body. Some of these conditions include Antiphospholipid Syndrome (which can make your blood clot too easily), Bullous Pemphigoid (a skin condition causing large blisters), Behçet's Syndrome (which can cause inflammation in different parts of your body), and conditions that affect your muscles, like Dermatomyositis and Immune-mediated Necrotizing Myopathy. It also includes Immune Thrombocytopenia, which is a blood disorder.
By continuing to study RAY121 in people who have already responded well to it, researchers hope to learn more about its long-term effects. This includes understanding if it continues to be safe and if it keeps helping people manage their conditions. This kind of long-term trial is very important for doctors and patients to understand how new medicines work in the real world over time.
Key takeaways
- This study is a long-term follow-up for people who responded well to RAY121 in an earlier trial.
- It's for adults aged 18-85 with specific immune conditions like APS, BP, BS, DM, IMNM, or ITP.
- The aim is to learn more about RAY121's long-term safety and effectiveness.
- Regular health checks and communication with the study team are part of participation.
- You can leave the study at any time without affecting your normal healthcare.
Who may be eligible?
To be considered for this study, you must be an adult between 18 and 85 years old. A very important requirement is that you must have already taken part in a previous study about RAY121 (called RAY902CT) and received at least four doses of the medicine. You also need to have shown that the treatment was helping you with your condition.
There are also some reasons why you wouldn't be able to join. For example, if you've had a severe allergic reaction to similar types of medicine before, or if you have certain types of active infections. You also can't be pregnant or breastfeeding, or planning to become pregnant. People who have had a Neisseria meningitidis infection or have a known weakened immune system would also not be able to join. It's also important that you're not planning to have surgery soon or currently taking other experimental treatments.
If you are a woman who could become pregnant, you would need to agree to use effective contraception (birth control) throughout the study and for about 20 weeks after your last dose of RAY121. Men would also need to use contraception and agree not to donate sperm during the study. The study doctor will go through all these details with you to make sure it's safe and suitable for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 85 years old?
- Did you take part in the previous RAY902CT study and receive RAY121?
- Did RAY121 help manage your condition in the earlier study?
- Are you able to attend appointments regularly and follow study instructions?
- Are you using effective birth control (if applicable) and not pregnant or breastfeeding?
What does participation involve?
If you join this study, you will continue to receive RAY121, as you did in the previous study. The study team will regularly check in with you to see how you're doing. This will involve regular visits to the clinic, where you will have health checks, blood tests, and assessments to see how your condition is responding to the treatment and to monitor for any side effects. You will need to tell the study team about any new health problems or changes you experience.
The total duration of your participation will depend on the study design, but it is a long-term extension, meaning you will be followed for a significant period beyond the initial study. The study doctor and staff will explain the schedule of visits and what each visit will involve in detail before you decide to participate.
Potential risks and benefits
Locations (58)
- Royal Prince Alfred HospitalVerified postcodeCamperdown, Australia
- Westmead HospitalVerified postcodeSydney, Australia
- Campbelltown Public HospitalVerified postcodeSydney, Australia
- The Alfred HospitalVerified postcodeMelbourne, Australia
- Box Hill HospitalVerified postcodeMelbourne, Australia
- AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische PharmakologieVerified postcodeVienna, Austria
- Diagnostic Consultation Center CONVEX EOODVerified postcodeSofia, Bulgaria
- "SHATHD" EAD SofiaVerified postcodeSofia, Bulgaria
- UMHAT "Prof. Dr. St. Kirkovich", ADVerified postcodeStara Zagora, Bulgaria
- DiIEX Recherche Sherbrooke, IncVerified postcodeSherbrooke, Canada
- Clinical Hospital Center "Sestre Milosrdnice"Verified postcodeZagreb, Croatia
- University hospital centre ZagrebVerified postcodeZagreb, Croatia
Common questions
What is RAY121?
RAY121 is a study medicine being investigated for different immune conditions.
What does 'immunological disease' mean?
It means your immune system mistakenly attacks healthy parts of your body, causing illness.
Do I have to pay to be in the study?
No, you don't have to pay to participate in this research study.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your medical care won't be affected.
How long will I be in this study?
This is a long-term study, so you will be followed for an extended period. The exact duration will be discussed with you by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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