A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

PHASE3CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 17, 2018

Primary Completion Date

December 3, 2021

Study Completion Date

December 3, 2021

Conditions
Cold Agglutinin Disease
Interventions
DRUG

sutimlimab (BIVV009)

Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)

DRUG

placebo

Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)

Trial Locations (53)

1090

Medical University of Vienna, Vienna

1105

Academisch Medisch Centrum, Amsterdam

1307

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

2060

ZNA Stuivenberg, Antwerp

2333

Leids Universitair Medisch Centrum, Leiden

3000

University Hospitals Leuven, Leuven

3168

Monash Medical Centre, Clayton

3350

Ballarat Oncology & Haematology, Ballarat

4556

USC Health Clinics, Buderim

5053

Haukeland University Hospital, Bergen

6005

Perth Blood Institute, West Perth

7030

St Olavs Hospital, Avdeling for blodsykdommer, Trondheim

10461

Montefiore Medical Center, New York

10595

New York Medical College at Westchester Medical Center, Valhalla

14033

Hôpital de Caen, Caen

15232

University of Pittsburgh Medical Center, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20007

Georgetown University Medical Center, Georgetown

20122

Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico, Milan

25123

A. O. Spedali Civili di Brescia, Brescia

27834

East Carolina University, Greenville

28222

Hospital Universitario Puerta de Hierro, Majadahonda

33331

Cleveland Clinic Florida, Weston

36100

U.O.C. Ematologia Ospedale San Bortolo, Vicenza

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic, Cleveland

45147

Universitätsklinikum Essen, Essen

46017

Hospital Universitario Dr. Peset, Valencia

49933

CHU d'Angers, Angers

53792

UW Hospitals and Clinics, Madison

63110

Washington University School of Medicine, St Louis

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

85711

Arizona Oncology Associates PC, Tucson

89081

Univ Ulm, Inst Klin. Transfusions. Immungen, Ulm

90033

USC/Keck School of Medicine, Los Angeles

91120

Hadassah Medical Center, Jerusalem

94000

Centre Hospitalier Henri Mondor, Créteil

4244916

Laniado Hospital, Netanya

9208530

Ishikawa Prefectural Central Hospital, Kanazawa

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

M5B1W8

St. Michael's Hospital, Toronto

H4A3J1

McGill University Health Center, Montreal

00168

"U.O.C. Ematologia- Policlinico A. Gemelli", Rome

670-8540

Japanese Red Cross Society Himeji Hospital, Himeji

259-1193

Tokai University Hospital, Isehara

565-0871

Osaka University Hospital, Suita

350-0495

Saitama Medical University Hospital, Iruma-gun

480-1195

Aichi Medical University Hospital, Nagakute

08036

Hospital Clinci i Provincial de Barcelona, Barcelona

LS9 7TF

St James Hospital, Leeds, Leeds

W12 0HS

Imperial College Healthcare NHS Trust, Hammersmith Hospital, London

WC1E 6AG

University College London, London

All Listed Sponsors
lead

Bioverativ, a Sanofi company

INDUSTRY

NCT03347422 - A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion | Biotech Hunter | Biotech Hunter