DDrare: Database of Drug Development for Rare Diseases

Searched query = "Autoimmune hemolytic anemia", "AIHA", "WAIHA", "Cold agglutinin disease", "CAD", "Paroxysmal cold hemoglobinuria", "MAIHA", "Evans syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ALXN1830; ANX005; APL-2; Acalabrutinib; BENDAMUSTINE HYDROCHLORIDE; BIV009; BIVV009; BIVV020; Bendamustine; Bendamustine, Rituximab; Blood sample; Blood samples; Bortezomib; CINRYZE® (C1 esterase inhibitor [human]); COMPLEMENT C1 ESTERASE INHIBITOR; Ciclosporin; Cinryze; Combination of a single dose anti-CD20 antibody and bortezomib; Complement C1 esterase inhibitor; EFALIZUMAB; Eculizumab; Efalizumab; Fludarabine; Fostamatinib; Fostamatinib 150 mg bid; Fostamatinib Disodium; Fostamatinib disodium; INCB050465; INCB050465 1 mg; INCB050465 2.5 mg; INCB050465 HYDROCHLORIDE; Ibrutinib; Interleukine-2; Isatuximab; Isatuximab SAR650984; KZR-616; Levact; Levamisole; M281; MabThera; Ninlaro; ORILANOLIMAB; Orilanolimab; Parsaclisib; Prednisolone; Prednisolone + mabthera; Prednisone; Prednisone, low dose rituximab; Procedure: spleen sample; R788, fostamatinib disodium hexahydrate (in USPI/FPI); R935788; RITUXIMAB; RVT-1401; RVT-1401 340 mg/weekly; RVT-1401 680 mg/weekly; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Rituximab; Rituximab (MABTHERA® or RITUXAN®).; Rituximab (Mabthera®); SYNT001; Sirolimus; Soliris; Soliris (R); Sutimlimab; Sutimlimab (BIVV009); TNT009; Tacrolimus; Urine sample; VELCADE*EV 1FL 3,5MG 1MG/ML; Velcade

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03347422 (ClinicalTrials.gov)	March 17, 2018	16/11/2017	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	A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion	Cold Agglutinin Disease	Drug: sutimlimab (BIVV009);Drug: placebo	Bioverativ, a Sanofi company	NULL	Active, not recruiting	18 Years	N/A	All	40	Phase 3	United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03347422
(ClinicalTrials.gov)

March 17, 2018

16/11/2017

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

Cold Agglutinin Disease

Drug: sutimlimab (BIVV009);Drug: placebo

Bioverativ, a Sanofi company

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom