Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

JRCT ID: jRCT2041240035

Registered date:27/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: APS, BP, BS, DM, IMNM, and ITP (Please refer to "Others" section for abbreviations)
• Date of first enrollment: 31/07/2024
• Target sample size: 144
• Countries of recruitment: US,Japan,Canada,Japan
• Study type: Interventional
• Intervention(s): RAY121: Injection

Outcome(s)

Primary Outcome

safety
- Incidence, severity, and causal relationship of AEs including SAEs
- Change in laboratory test results, vital signs, and electrocardiogram

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Signed informed consent form
2. Age >= 18 and <=75 at the time of signing informed consent form (except for BP; Age >=18 and <= 85 with Karnofsky score >= 60% at screening)
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

Exclude 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

Related Information

• Primary Sponsor: Hashimoto Akiko
• Secondary ID(s): NCT06371417,2023-507692-21-0