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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChugai Pharmaceutical

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RAY121

Treatment groups

144 Participants
are divided into 1 treatment group

Sponsors and collaborators