Experimental drug for rare blood disorder tested for long-term safety

NCT ID NCT04802057

Terminated Disease control Sponsor: Bioverativ, a Sanofi company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the long-term safety of a drug called SAR445088 in people with cold agglutinin disease, a rare condition where the immune system attacks red blood cells. Only 9 participants were enrolled, and the study was terminated early. The goal was to see if the drug is safe to use over time and how it affects markers of red blood cell destruction.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: SAR445088 (a drug given by injection or IV)
What this could lead to: If successful, this could point toward a treatment that controls red blood cell destruction in cold agglutinin disease.
What could go wrong: This was a very small, early-phase study that was terminated early, so results are limited. The drug may not prove safe or effective in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia cold agglutinin disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AUTOIMMUNE HAEMOLYTIC ANAEMIA

Contacts and locations

Locations

Investigational Site Number : 2760001

Essen, 45147, Germany
Investigational Site Number : 3800001

Milan, Milano, 20122, Italy
Investigational Site Number : 5280001

Amsterdam, 1081 HV, Netherlands
Investigational Site Number : 5780001

Bergen, 5021, Norway
Investigational Site Number : 8260001

London, London, City of, NW1 2PG, United Kingdom

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