By InvitationPhase 1

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

Australia144 participantsStarted 2024-12-09

Plain-language summary

This is a long-term extension trial of RAY121 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
✓. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
✓. Ability to comply with the study protocol, in the investigator's judgment
✓. 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
✓. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion criteria

✕. History of anaphylaxis or hypersensitivity to a biologic agent
✕. Known active infection with encapsuled bacteria
✕. History of Neisseria meningitidis infection
✕. Planned surgery
✕. Pregnant or breastfeeding, or intending to become pregnant
✕. Clinically significant electrocardiogram abnormalities
✕. Illicit drug or alcohol abuse
✕. Known or suspected immune deficiency

What they're measuring

Adverse events (AEs)

Timeframe: Baseline to Week 52

Trial details

NCT IDNCT06723106

SponsorChugai Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Antiphospholipid Syndrome (APS) trials