NCT04802057 is a Phase 1 clinical trial of SAR445088 in Autoimmune Haemolytic Anaemia, sponsored by Bioverativ, a Sanofi company.

Who is sponsoring NCT04802057?

NCT04802057 is sponsored by Bioverativ, a Sanofi company.

What drugs are being tested in NCT04802057?

Interventions in NCT04802057: SAR445088.

What condition does NCT04802057 study?

NCT04802057 studies Autoimmune Haemolytic Anaemia.

Is NCT04802057 still recruiting?

NCT04802057 is currently terminated. Last updated 11 September 2025.

Last reviewed 2025-09-11 · How we verify

NCT04802057

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

Terminated Phase 1 Last updated 11 September 2025

What this trial tests

Phase 1 trial testing SAR445088 in Autoimmune Haemolytic Anaemia in 9 participants. Terminated before completion.

Timeline

22 March 2021

Primary endpoint
4 March 2025

4 March 2025

Quick facts

Lead sponsor	Bioverativ, a Sanofi company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	22 March 2021
Primary completion	4 March 2025
Estimated completion	4 March 2025
Sites	5 locations across Italy, Netherlands, United Kingdom, Germany, Norway

Drugs / interventions tested

SAR445088 — full drug profile →

Conditions studied

Autoimmune Haemolytic Anaemia — all drugs for Autoimmune Haemolytic Anaemia →

Sponsor

Bioverativ, a Sanofi company — full company profile →

Who can join

18 and older, any sex, with Autoimmune Haemolytic Anaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088 Secondary Objective: To assess, in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088: * The long-term effect of SAR445088 on complement mediated hemolysis * The long-term pharmacodynamics (PD) effect of SAR445088 relating to complement inhibition * The long-term pharmacokinetic (PK) profile of SAR445088 * The long-term immunogenicity of SAR445088

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Complement C1s as a diagnostic marker and therapeutic target: Progress and propective.
Ye J, Yang P, Yang Y, Xia S. · · 2022 · cited 25× · PMID 36275687 · DOI 10.3389/fimmu.2022.1015128
CD38 as theranostic target in oncology.
Bocuzzi V, Bridoux J, Pirotte M, Withofs N, et al · · 2024 · cited 17× · PMID 39501292 · DOI 10.1186/s12967-024-05768-6
Safety, tolerability, and activity of the active C1s antibody riliprubart in cold agglutinin disease: a phase 1b study.
D'Sa S, Vos JMI, Barcellini W, Wardęcki M, et al · · 2024 · cited 13× · PMID 38085846 · DOI 10.1182/blood.2023022153
Sutimlimab for the Treatment of Cold Agglutinin Disease.
Berentsen S. · · 2023 · cited 7× · PMID 37153870 · DOI 10.1097/hs9.0000000000000879
Beneath the surface in autoimmune hemolytic anemia: pathogenetic networks, therapeutic advancements and open questions.
Costa A, Mulas O, Mereu AM, Schintu M, et al · · 2025 · cited 2× · PMID 40821796 · DOI 10.3389/fimmu.2025.1624667
[The treatment strategies of autoimmune hemolytic anemia].
Yue WR, Wu T, Wang XQ. · · 2024 · cited 1× · PMID 39134500 · DOI 10.3760/cma.j.cn121090-20231027-00236
Confirmation of Fixed Quarterly Riliprubart Regimen in Patients with Cold Agglutinin Disease Using Population PK/PD and Exposure-Response Analyses.
Chow T, Wardecki M, Storek M, Wong N. · · 2025 · PMID 40308078 · DOI 10.1002/cpt.3692
EHA2024 Hybrid Congress
· 2024

Verify or expand the search:

Other recruiting trials for Autoimmune Haemolytic Anaemia

Currently open trials in the same condition.

NCT07086976 — A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Partici · Phase 3 · recruiting

Other Bioverativ, a Sanofi company trials

Trials by the same sponsor.

NCT04770935 — To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 V · Phase 1 · completed
NCT04658472 — Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) · Phase 2 · completed
NCT04644575 — Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A · Phase 3 · active not recruiting
NCT04759131 — Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A · Phase 3 · completed
NCT04669600 — A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04802057 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bioverativ, a Sanofi company
Last refreshed: 11 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04802057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing