New drug BIVV020 tested for rare blood disorder

NCT ID NCT04269551

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

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

Summary

This early-stage trial tested a single dose of the drug BIVV020 in 12 adults with cold agglutinin disease, a rare condition where the immune system mistakenly attacks red blood cells. The main goal was to see if the drug is safe and tolerable. Researchers also looked at how it affects red blood cell breakdown and the immune system's complement pathway.

What this could mean

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

Active substance: BIVV020 (a drug given as a single intravenous injection)
What this could lead to: If successful, this could point toward a new treatment option for cold agglutinin disease, a rare autoimmune condition that destroys red blood cells.
What could go wrong: This is a very early, small Phase 1b trial with only 12 participants. It primarily tests safety, not effectiveness, so the drug may not work or could have side effects.

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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, 1105AZ, Netherlands
Investigational Site Number :5780001

Bergen, 5021, Norway
Investigational Site Number :8260001

London, London, City of, NW1 2PJ, United Kingdom
Investigational Site Number :8400002

Fayetteville, Georgia, 30214, United States
Investigational Site Number :8400004

Seattle, Washington, 98108, United States
Investigational Site Number :8400006

The Bronx, New York, 10467, United States
Investigational Site Number :8400008

Pittsburgh, Pennsylvania, 15232, United States
Investigational Site Number :8400009

St Louis, Missouri, 63110, United States

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