RAY121 / Roche - LARVOL DELTA

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Bullous Pemphigoid • Dermatology • Dermatopathology • Genetic Disorders • Hematological Disorders • Immunology

Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial) (clinicaltrials.gov) - P1 | N=144 | Enrolling by invitation | Sponsor: Chugai Pharmaceutical | Trial completion date: Apr 2027 ➔ Feb 2028 | Trial primary completion date: Apr 2027 ➔ Feb 2028

Pan tumor • Trial completion date • Trial primary completion date • Bullous Pemphigoid • Dermatology • Dermatopathology • Genetic Disorders • Hematological Disorders • Immunology

RAY104CT: A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE-DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS (clinicaltrialsregister.eu) - P1 | N=36 | Completed | Sponsor: Chugai Pharmaceutical Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion

Long lasting complement neutralisation by RAY121, an engineered anti-C1s antibody with C1q displacement function. (PubMed, EBioMedicine) - "RAY121 is able to neutralise the CP for an extended duration and is effective at doses that can be administered subcutaneously for convenient treatment. These data present RAY121 as a promising agent for the treatment of CP-driven autoimmune disorders."

Journal • Immunology

Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial) (clinicaltrials.gov) - P1 | N=144 | Enrolling by invitation | Sponsor: Chugai Pharmaceutical

New P1 trial • Pan tumor • Bullous Pemphigoid • Dermatology • Dermatomyositis • Dermatopathology • Genetic Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Myositis • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura

RAY121, a Novel Recycling Monoclonal Antibody Against Complement C1s: Safety, Pharmacokinetic and Pharmacodynamic Data from a Phase 1a First in Human Clinical Trial in Healthy Adults (ACR Convergence 2024) - "In summary, the FIH study of RAY121 demonstrated that the application of Recycling Antibody engineering has been indeed translated into the substantial extension of the half-life of serum drug concentrations and the prolonged efficient suppression of CP with the favorable safety and PK profile. As a result, it has been hypothesized that infrequent SC dose of RAY121 enables maintaining complete suppression of classical complement pathway. The characteristic of monthly SC injection of RAY121 has a significant clinical value and is expected to be a new therapy, in reducing clinical burden on patients with autoimmune diseases."

Clinical • P1 data • PK/PD data • Immunology • C1S

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Chugai Pharmaceutical | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Bullous Pemphigoid • Dermatology • Dermatomyositis • Dermatopathology • Genetic Disorders • Hematological Disorders • Immunology • Myositis • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Chugai Pharmaceutical

New P1 trial • Pan tumor • Bullous Pemphigoid • Dermatology • Dermatomyositis • Dermatopathology • Genetic Disorders • Hematological Disorders • Immunology • Myositis • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura