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New drug BIVV020 tested for rare blood disorder

NCT ID NCT04269551

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Jun 2020

Finished

Jan 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by: 1. Chronic hemolysis per Investigator's judgement, 2. Polyspecific direct antiglobulin test (DAT) positive, 3. Monospecific DAT strongly positive for C3d, 4. Cold agglutinin (CAg) titer ≥ 64 at 4 C; and, 5. IgG DAT ≤1+. * A hemoglobin level ≤11 mg/dL. * A total bilirubin level above the normal reference range that is thought to be due to hemolysis. * Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B meningococcus and Streptococcus pneumoniae) within five years of screening or willing to complete protocol specified vaccinations. * Having given written informed consent prior to undertaking any study-related procedure. Exclusion criteria: * Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high grade hematologic malignancy, or known solid organ tumor. * Clinically relevant infection of any kind within one month preceding screening. * Treatment with anti-CD20 monotherapy within three months or anti CD20 combination therapies within six months prior to screening. * Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening. * Any specific complement system inhibitor within three months prior to screening. * Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within three months prior to screening. * If female, pregnant or lactating. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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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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