Antiphospholipid Syndrome (APS), Behçet's Syndrome (BS), Bullous Pemphigoid (BP), Dermatomyositis (DM), Immune-mediated Necrotizing Myopathy (IMNM), Immune Thrombocytopenia (ITP)
Conditions
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).
Interventions
DRUGRAY121
Injection
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form 2. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses 3. Ability to comply with the study protocol, in the investigator's judgment 4. 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 5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion criteria
1. History of anaphylaxis or hypersensitivity to a biologic agent 2. Known active infection with encapsuled bacteria 3. History of Neisseria meningitidis infection 4. Planned surgery 5. Pregnant or breastfeeding, or intending to become pregnant 6. Clinically significant electrocardiogram abnormalities 7. Illicit drug or alcohol abuse 8. Known or suspected immune deficiency 9. Treatment with investigational therapy other than RAY121 10. Vaccination with a live vaccine within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Baseline to Week 52 | Incidence, severity, and causal relationship of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAY121 concentration | Baseline to Week 52 | Serum RAY121 concentration |
| 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 |
| 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 |
Countries
Australia, Austria, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Spain, Taiwan, Turkey (Türkiye)
Contacts
STUDY_DIRECTORSponsor Chugai Pharmaceutical Co.Ltd
clinical-trials@chugai-pharm.co.jp
Outcome results
None listed