Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) (NCT06371417) | Clinical Trial Compass
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
United States144 participantsStarted 2024-08-19
Plain-language summary
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form
✓. 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)
✓. Ability to comply with the study protocol
✓. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods
✓. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
✓. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):
✓. BP cohort:
✓. BS cohort:
Exclusion criteria
✕. History of anaphylaxis or hypersensitivity to a biologic agent
✕. Active infection requiring systemic antiviral, antibiotics or antifungal
✕. Planned surgery during the study
✕. Pregnant or breastfeeding, or intending to become pregnant
✕. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study