A Phase 1 interventional study of BIVV020 in Autoimmune Haemolytic Anaemia, sponsored by Bioverativ, a Sanofi company. Completed at 10 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Bioverativ, a Sanofi company (part of Sanofi) · Phase 1, Interventional, and Treatment
Among 31 studies in Anemia, Hemolytic, Autoimmune with a site in United States — 4 open to participants now, 9 under way, 4 of them phase 3. Anemia, Hemolytic, Autoimmune · United States.
Among the 31 studies in Anemia, Hemolytic, Autoimmune with a site in United States, this one is the 21st largest by enrollment of the 30 interventional ones that give a count, is one of 3 that started in 2020, is one of 3 in phase 1, and was the 17th registered.
103 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 39 are open to participants now.
Browse Anemia, Hemolytic, Autoimmune studies →4 of the 31 studies in Anemia, Hemolytic, Autoimmune with a site in United States are open now. Recruiting first, the newest first:
Sanofi · Sites in United States, Argentina, Austria and 15 more countries
Ages 18+
Lakefront Biotherapeutics West LLC · Sites in United States, Australia
Ages 18–75
Rigel Pharmaceuticals · Sites in United States, Australia, Austria and 15 more countries
Ages 18–100
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Sites in United States, Denmark, Germany and 1 more country
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 24 Anemia, Hemolytic, Autoimmune studies recruiting now, 12 (50%) set no upper age limit and 10 (42%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 18 · Phase 3 9
First in 1997; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 23 across 78 interventional studies indexed under Anemia, Hemolytic, Autoimmune.
Median enrollment 24 across the 30 interventional studies, 429 across the 1 observational. Of the 18 that completed or were terminated, 13 (72%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 31 have an industry lead sponsor. The 10 most frequent:
This study is registered under Bioverativ, a Sanofi company, one of the names counted as Sanofi. Under that name alone:
Bioverativ, a Sanofi company is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Sanofi has 9 studies filed under Anemia, Hemolytic, Autoimmune — fewer than ten, so there is no comparison to draw.
1 of the studies in Anemia, Hemolytic, Autoimmune with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07083960Lakefront Biotherapeutics West LLCOM336 in Autoimmune Cytopenias | 2026-12 |
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Among the 31 studies in Anemia, Hemolytic, Autoimmune with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Primary Objective:
To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020
Secondary Objectives:
To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020:
Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single administration dose 1, plus two optional doses of BIVV020 administered intravenously.
Drug: BIVV020
Pharmaceutical form:solution for injection Route of administration: intravenous
Assessment of adverse events (AEs)
Number of participants with adverse events (AEs)
Time frame: Screening to Day 106
Mean change from baseline in bilirubin over time
Assessment of total bilirubin
Time frame: Day 1 to Day 106
Mean change from baseline in hemoglobin over time
Assessment of hemoglobin
Time frame: Day 1 to Day 106
Complement System Classical Pathway Levels as Measured by WIESLAB Assay
Inhibition by BIVV020 of the complement system classical pathway measured by the WIESLAB assay
Time frame: Day 1 to Day 106
Complement System Alternative Pathway Levels as Measured by WIESLAB Assay
Effect of BIVV0020 on the complement system alternative pathway measured by the WIESLAB assay
Time frame: Day 1 to Day 106
Total Complement (CH50) Levels
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays.
Time frame: Day 1 to Day 106
Total Complement Factor C4 Levels
Total C4 Levels will be assessed in plasma using complement assays
Time frame: Day 1 to Day 106
PK parameter: Cmax
Observed maximum plasma concentration
Time frame: Day 1 to Day 106
PK parameter: tmax
Observed first time to reach Cmax
Time frame: Day 1 to Day 106
PK parameter: AUClast
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Time frame: Day 1 to Day 106
PK parameter: AUC0-∞
Calculated area under the plasma concentration versus time curve extrapolated to infinity
Time frame: Day 1 to Day 106
Number of participants with anti-BIVV antibodies
Observed number of participants with BIVV020 antibodies
Time frame: Day 1 to Day 106
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Jun 2020 to primary completion in Jan 2022, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Riliprubart
Anemia, Hemolytic, Autoimmune →
Bioverativ, a Sanofi company →