Status:
TERMINATED
Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088
Lead Sponsor:
Bioverativ, a Sanofi company
Conditions:
Autoimmune Haemolytic Anaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objective: To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088 Secondary Objective: To assess, in patients with...
Detailed Description
The screening period for this study is up to 6 weeks. The treatment period for this study will continue for 2 years after last participant entered Part 2 (either having switched from Part 1 or as a SA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04802057
Start Date
March 22 2021
End Date
March 4 2025
Last Update
September 11 2025
Active Locations (5)
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1
Investigational Site Number : 2760001
Essen, Germany, 45147
2
Investigational Site Number : 3800001
Milan, Milano, Italy, 20122
3
Investigational Site Number : 5280001
Amsterdam, Netherlands, 1081 HV
4
Investigational Site Number : 5780001
Bergen, Norway, 5021