APS, BP, BS, DM, IMNM, and ITP (Please refer to "Others" section for abbreviations)
Conditions
Interventions
RAY121: Injection
Sponsors
Hashimoto Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form 2. Age >= 18 and <=85 at the time of signing informed consent form 3. Ability to comply with the study protocol 4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods 5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm 6. Disease specific criteria defined in the protocol
Exclusion criteria
Exclusion criteria: 1. History of anaphylaxis or hypersensitivity to a biologic agent 2. Active infection requiring systemic antiviral, antibiotics or antifungal 3. Planned surgery during the study 4. Pregnant or breastfeeding, or intending to become pregnant 5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study 6. Clinically significant ECG abnormalities 7. Illicit drug or alcohol abuse 8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjogren's syndrome in DM and IMNM) 9. Positive for hepatitis B surface antigen 10. Positive for hepatitis C virus antibody 11. Positive for human immunodeficiency virus antibody 12. Evidence of current infection with tuberculosis 13. History of cancer within 5 years 14. Treatment with investigational therapy within 28 days or 5 half-lives 15. Previous and current treatment with anti-C1s antibody at any time 16. Other complement inhibitors within 3 months 17. Patients who receive any treatments which fall into the Prohibited Therapy Criteria 18. Patients with an elevated alanine aminotransferase or aspartate aminotransferase >1.5 x ULN in combination with an elevated total bilirubin >1.5 x ULN 19. Disease specific criteria defined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Incidence, severity, and causal relationship of AEs including SAEs - Change in laboratory test results, vital signs, and electrocardiogram | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy, phamacokinetics, phamacodynamics, other - Serum RAY121 concentration and relevant PK parameters - Complement related PD biomarkers - Prevalence and incidence of anti-RAY121 antibodies - Disease specific secondary efficacy endpoints defined in the protocol | — |
Countries
Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Spain, Taiwan, US
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed