A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors (COMMODORE 1)
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-506526-37-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 157
General Inclusion Criteria (All Patients) Body weight >= 40 kg at screening, General Inclusion Criteria (All Patients) Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry evaluation of WBCs, General Inclusion Criteria (All Patients) Platelet count >= 30,000/mm3 at screening without transfusion support within 7 days of lab testing, For Patients in Randomized Arms (Arm A and B) Age >= 18 years Documented treatment with eculizumab according to the approved dosing recommended for PNH and completion of a minimum of 24 weeks of treatment prior to Day 1, For Patients in Randomized Arms (Arm A and B) Lactate dehydrogenase (LDH) <= 1.5 × ULN at screening, For Patients in Non-Randomized Arm (Arm C) - Age <18 years, currently treated with eculizumab OR - Currently treated with ravulizumab OR - Currently treated with eculizumab at higher-than-approved doses OR - Patients with known C5 polymorphism and poorly controlled hemolysis by eculizumab or ravulizumab - For adult patients currently treated with approved doses of eculizumab Note: In France and Czech Republic patients under 18 years of age are not eligible to participate in the study.
Major Adverse Vascular Event within 6 months prior to first drug administration (Day 1), History of allogeneic bone marrow transplantation, Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration, History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high, Pregnant or breastfeeding, or intending to become pregnant during the study or within 46 weeks (approximately 10.5 months) after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label) Note: In France and Czech republic female patients of childbearing potential are not eligible to participate in the study., Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the patient, or would, in the opinion of the Investigator, preclude the patient’s safe participation in and completion of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method