MedTrace Logo

Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

NCT04802057 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-11

No results posted yet for this study

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 cold agglutinin disease (CAD), after multiple doses of SAR445088:

* The long-term effect of SAR445088 on complement mediated hemolysis
* The long-term pharmacodynamics (PD) effect of SAR445088 relating to complement inhibition
* The long-term pharmacokinetic (PK) profile of SAR445088
* The long-term immunogenicity of SAR445088

Conditions

  • Autoimmune Haemolytic Anaemia

Interventions

DRUG

SAR445088

Pharmaceutical form: solution for injection Route of administration: IV and SC (Part 1) IV (Part 2)

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2025-03-04
Completion
2025-03-04
FDA Drug
Yes

Countries

  • Germany
  • Italy
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802057 on ClinicalTrials.gov