Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT04802057
Eligibility Criteria:
Inclusion Criteria:
* Male and female adult patients ≥18 years of age with CAD who were previously treated with SAR445088 and met criteria the below criteria for entry into Part 1:
* met the eligibility criteria of a previous study evaluating SAR445088;
* successfully enrolled and completed dosing in a previous study evaluating SAR445088;
* successfully completed end of study procedures in a previous study evaluating SAR445088; and
* per Investigator judgement, had a favorable benefit-to-risk profile after receiving SAR445088.
* OR were never treated with SAR445088 before entering Part 2, and met the below criteria to establish CAD diagnosis:
* chronic hemolysis;
* polyspecific direct antiglobulin test (DAT) positive status;
* monospecific DAT strongly positive for C3d;
* cold agglutinin \[CAg\] titer ≥64 at 4°C;
* IgG DAT ≤1+;
* hemoglobin level ≤10 g/dL;
* elevated bilirubin not attributable to liver disease;
* Documented vaccinations against encapsulated bacterial pathogens given within five years of enrollment and at least 14 days prior to dosing (vaccinations have to be initiated at least 14 days prior to dosing and completed before Week 5 of Part 2).
* Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
* Having given written informed consent prior to undertaking any study-related procedure.
Exclusion Criteria:
* Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high-grade hematologic malignancy, or known solid organ tumor.
* Clinically relevant infection within 1 month of enrollment.
* Clinical diagnosis of systemic lupus erythematosus (SLE).
* Treatment with anti-CD20 monotherapy within 3 months or anti-CD20 combination therapies within 6 months prior to screening.
* Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening.
* Any specific complement system inhibitor other than SAR445088 (eg, eculizumab) within 3 months prior to screening.
* Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within 3 months prior to screening.
* History of hypersensitivity to SAR445088 or any of its components.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04802057
Study Brief:
Protocol Section:
NCT04802057