Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Key facts
- Who runs it
- Chugai Pharmaceutical
- Where
- Kristiansand and Stavanger, NorwaySee the 2 sitesAlso in 18 other countries, 60 sites
- Trial code
- Status
- Enrolling by invitation
- Phase
- Phase 1
- People taking part
- 144 people, planned
- Started
- 9 Dec 2024
- Expected to end
- 28 Feb 2028
- Type of study
- Interventional
- Treatments tested
- RAY121
- Record updated
- 17 July 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Norway
Also in 18 other countries, 60 sites
- Sorlandet sykehus KristiansandKristiansand, NorwayNo longer taking part
- Stavanger UniversitetssjukehusStavanger, NorwayNo longer taking part
About the trial
What the trial wants to find out
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).
The group in the trial
- RAY121Treatment being tested
All enrolled patients will receive RAY121 multiple dose
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)
- Fit questions
- Built from NCT06723106, who can take part
- Record updated
- 17 July 2026