Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
- Conditions
- Antiphospholipid Syndrome (APS)Bullous Pemphigoid (BP)Dermatomyositis (DM)Immune-mediated Necrotizing Myopathy (IMNM)Behçet's Syndrome (BS)Immune Thrombocytopenia (ITP)
- Interventions
- Registration Number
- NCT06723106
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 144
- 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
- History of anaphylaxis or hypersensitivity to a biologic agent
- Known active infection with encapsuled bacteria
- History of Neisseria meningitidis infection
- Planned surgery
- Pregnant or breastfeeding, or intending to become pregnant
- Clinically significant electrocardiogram abnormalities
- Illicit drug or alcohol abuse
- Known or suspected immune deficiency
- Treatment with investigational therapy other than RAY121
- Vaccination with a live vaccine within 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RAY121 RAY121 All enrolled patients will receive RAY121 multiple dose
- Primary Outcome Measures
Name Time Method Adverse events (AEs) Baseline to Week 52 Incidence, severity, and causal relationship of AEs
- Secondary Outcome Measures
Name Time Method RAY121 concentration Baseline to Week 52 Serum RAY121 concentration
Change from baseline in complement activity (classical pathway) Baseline to Week 52 Level of complement activity (classical pathway) will be measured and assessed against baseline values
Anti-RAY121 antibodies Baseline to Week 52 Titer of anti-RAY121 antibodies
Change from baseline in active C1s Baseline to Week 52 Concentration of active C1s will be measured and assessed against baseline values
Change from baseline in total C1s Baseline to Week 52 Concentration of total C1s will be measured and assessed against baseline values
Related Research Topics
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Trial Locations
- Locations (54)
DiIEX Recherche Sherbrooke, Inc
🇨🇦Sherbrooke, Quebec, Canada
Okayama University Hospital
🇯🇵Okayama, Japan
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
Campbelltown Public Hospital
🇦🇺Sydney, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Box Hill Hospital
🇦🇺Melbourne, Victoria, Australia
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie
🇦🇹Vienna, Austria
Diagnostic Consultation Center CONVEX EOOD
🇧🇬Sofia, Sofia City Province, Bulgaria
"SHATHD" EAD Sofia
🇧🇬Sofia, Sofia City Province, Bulgaria
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