Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Key facts
- Phase
- Phase 1
This trial has no sites in United States.
It has sites in 19 countries. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06723106, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chugai Pharmaceutical
- Trial code
- NCT06723106
- Record updated
- 17 July 2026
- Original description
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).Read full original descriptionShow less
Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE 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).
Inclusion: Signed informed consent form; Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses; Ability to comply with the study protocol, in the investigator's judgment; For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121; For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
Exclusion: Planned surgery; Illicit drug or alcohol abuse; Treatment with investigational therapy other than RAY121; Vaccination with a live vaccine within 4 weeks; History of anaphylaxis or hypersensitivity to a biologic agent; Known active infection with encapsuled bacteria; History of Neisseria meningitidis infection; Pregnant or breastfeeding, or intending to become pregnant; Clinically significant electrocardiogram abnormalities; Known or suspected immune deficiency.