A Phase 1 interventional study of SAR445088 in Autoimmune Haemolytic Anaemia, sponsored by Bioverativ, a Sanofi company. Terminated at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Bioverativ, a Sanofi company (part of Sanofi) · Phase 1, Interventional, and Treatment
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 cold agglutinin disease (CAD), after multiple doses of SAR445088:
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 SAR445088-naïve participant), or until SAR445088 development is discontinued, whichever comes first.
97 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 42 are open to participants now.
This study's enrollment of 9 is below the median of 24 across 73 interventional studies indexed under Anemia, Hemolytic, Autoimmune.
Browse Anemia, Hemolytic, Autoimmune studies →Bioverativ, a Sanofi company is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
First submitted after Bioverativ became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
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:
OR were never treated with SAR445088 before entering Part 2, and met the below criteria to establish CAD diagnosis:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Repeat dose of SAR445088
Drug: SAR445088
Pharmaceutical form: solution for injection Route of administration: IV and SC (Part 1) IV (Part 2)
Number of participants with treatment-emergent adverse events (TEAE)
The number of participants experiencing TEAEs will be reported for the overall safety population.
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Mean change from baseline in total bilirubin over time
Assessment of total bilirubin
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Mean change from baseline in hemoglobin over time
Assessment of hemoglobin
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Mean change from baseline in lactate dehydrogenase over time
Assessment of lactate dehydrogenase
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Mean change from baseline in reticulocyte count over time
Assessment of reticulocyte count
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Complement System Classical Pathway Levels as Measured by WIESLAB Assay
Inhibition by SAR445088 of the complement system classical pathway measured by the WIESLAB assay.
Time frame: Day 1 or Day 1-IV to Week 48-IV
Complement System Alternative Pathway Levels as Measured by WIESLAB Assay
Part 1: Effect of SAR445088 on the complement system alternative pathway measured by the WIESLAB assay.
Time frame: Day 1 to Week 24
Mean change in CH50 over time
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays.
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Total Complement Factor C4 Levels
Total C4 Levels will be assessed in plasma using complement assays
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
PK parameter: Cmax
Maximum observed concentration (Cmax) of SAR445088 in plasma will be assessed
Time frame: Day 1 or Day 1-IV to Week 48-IV
PK Parameter: AUC
Area under the plasma concentration versus time curve calculated using the trapezoidal method at steady state
Time frame: Day 1 or Day 1-IV to Week 48-IV
Number of participants with anti-SAR445088 antibodies
The immunogenicity for SAR445088 will be assessed by summarizing the number of participants with anti-SAR445088 antibodies (ADA)
Time frame: Day 1 or Day 1-IV to end of study, approximately 6 years
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Anemia, Hemolytic, Autoimmune→