New drug BIVV020 tested for rare blood disorder

NCT ID NCT04269551

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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