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Enrolling by Invitation

NCT Number: NCT06723106

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

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).

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Key information

Conditions

Antiphospholipid Syndrome (APS) Antiphospholipid Syndrome Autoimmune Diseases Behcet Syndrome Behçet's Syndrome (BS) Blood Coagulation Disorders Blood Platelet Disorders Bullous Pemphigoid (BP) Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cytopenia Dermatomyositis Dermatomyositis (DM) Eye Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hereditary Autoinflammatory Diseases Immune System Diseases Immune Thrombocytopenia (ITP) Immune-mediated Necrotizing Myopathy (IMNM) Mouth Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Pemphigoid, Bullous Polymyositis Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin Diseases, Vesiculobullous Skin Manifestations Skin and Connective Tissue Diseases Stomatognathic Diseases Thrombocytopenia Thrombotic Microangiopathies Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Treatment with investigational therapy other than RAY121
  • Vaccination with a live vaccine within 4 weeks

Treatment and study plan

RAY121

Drug

Injection

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Baseline to Week 52

    Incidence, severity, and causal relationship of AEs

Secondary outcomes

  1. RAY121 concentration

    Time frame: Baseline to Week 52

    Serum RAY121 concentration

  2. Change from baseline in active C1s

    Time frame: Baseline to Week 52

    Concentration of active C1s will be measured and assessed against baseline values

  3. Change from baseline in total C1s

    Time frame: Baseline to Week 52

    Concentration of total C1s will be measured and assessed against baseline values

  4. Change from baseline in complement activity (classical pathway)

    Time frame: Baseline to Week 52

    Level of complement activity (classical pathway) will be measured and assessed against baseline values

  5. Anti-RAY121 antibodies

    Time frame: Baseline to Week 52

    Titer of anti-RAY121 antibodies

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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