RAINBOW

Open-label trial with a long-term extension of RAY121 for the inhibition of the classical complement pathway in immunological diseases. Phase 1b

Condition studied : Bullous pemphigoid, Antiphospholipid syndrome, Autoimmune necrotising myopathy, Behçet’s disease, Dermatomyositis, Immune thrombocytopenic purpura
Treatment : Repeated subcutaneous administration of RAY121
Inclusion criteria :

– Have been diagnosed with Behçet’s disease, dermatomyositis, immune thrombocytopenic purpura, autoimmune necrotising myopathy or bullous pemphigoid
– Have a disease that is refractory to or intolerant of standard maintenance treatments
– Have been vaccinated against meningococcal serogroups A, B, C, W and Y, pneumococcus, and Haemophilus influenzae type B.

Exclusion criteria :

– Overlapping connective tissue disorders (except dermatomyositis/Gougerot-Sjögren or autoimmune necrotising myopathy/Gougerot-Sjögren)
– Active infection

Sponsor : CHUGAI
Principal Investigator : Pr. Christian Jorgensen
: NCT06371417 | Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | ClinicalTrials.gov
Investigator
Pr. Christian Jorgensen
Director
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