Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)

Launched by CHUGAI PHARMACEUTICAL · Dec 6, 2024

Keywords

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Gender

ALL

Eligibility criteria

• 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