A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.
More information can be found here: https://clinicaltrials.argenx.com/advancenext
Inclusion Criteria:
Exclusion Criteria:
Clinicaltrials@argenx.com857-350-4834
Phoenix, Arizona 85054, United States
ramirez.alexandria@mayo.edu480-574-1853
Los Angeles, California 90033, United States
Greenville, North Carolina 27834, United States
Sofia, 1431, Bulgaria
Sofia, 1797, Bulgaria
Beijing, 100050, China
Huai'an, 223300, China
Tianjin, 300020, China
Wuhan, China
Dijon, 21079, France
Florence, 50134, Italy
Reggio Emilia, 42123, Italy
Lodz, 93-513, Poland
Lublin, 20-090, Poland
Sibiu, 550245, Romania
L'Hospitalet de Llobregat, 08908, Spain
Birmingham, B15 2GW, United Kingdom
Bradford, BD9 6RJ, United Kingdom
Glasgow, G4 0ET, United Kingdom
Leicester, LE1 5WW, United Kingdom
London, E1 2ES, United Kingdom
London, W12 0HS, United Kingdom
duran_c@med.usc.edu323-865-0371
Christina.Spencer@profoundresearch.com760-272-4749
gianni.solis@cuanschutz.edu303-724-1513
loren.rodriguez@yale.edu203-623-5753
js4936@georgetown.edu202-687-0116
antojean.xavior@bsd.uchicago.edu773-834-9316
darby-donovan@uiowa.edu319-384-9643
cscott@tulane.edu504-988-5433
agopala7@hfhs.org313-556-8729
wrig1316@umn.edu6126269520
melanie.gonzalez@regionalcancercare.org732-530-8666 X 1430
kristin.byrne@duke.edu919-681-2668
wootenk16@ecu.edu252-744-3617
donna.kane1@uhhospitals.org216-844-8123
Nives.Quaye@osumc.edu614-293-5176
kellie.larsen@integrishealth.org405-636-7951
clemens.schmitt@keplerklinkum.at+4357680831610
robert.milanov@ordensklinikum.at+4373276764457
sonja.heibl@klinikum-wegr.at+43724241592201
dramine66@gmail.com+359884993594
e_hadji58@yahoo.com+359898901090
aradinoff@hotmail.com+359884933151
t.yankova@hematology.bg+359898719792
dr.alaikov@gmail.com+359888627955
dr.maria.dtodorova@gmail.com+359896414650
wangzhao@ccmu.edu.cn13910623679
iqihui450052@sina.com18311319952
13855291898@163.com13855291898
zzhangzhihua@163.com857-350-4834
173064266@qq.com18547144520
21347725@qq.com13770498080
547081777@qq.com18719190842
chenyunfei@ihcams.ac.cn18502220788
xu_min1015@163.com13212794115
rmleiyang2023@163.com15261533080
luomingmm@126.com13952846267
dpulanic@yahoo.com+38512388277
ivo.demel@fno.cz+420597374576
olga.cerna@fnkv.cz+420267162887
gourguechon.clement@chu-amiens.fr+33322455914
Marc.michel2@aphp.fr+33149812076
bernard.bonnotte@chu-dijon.fr+33380293432
Karolin.Trautmann@ukdd.de+493514582311
clinicaltrials@argenx.com
studienzentrum-haemaSZT@uk-essen.de+4920172384763
nagy.zsolt@med.semmelweis-univ.hu+36208258660
lazarzsolt1982@gmail.com+3696418244
CTRU@mater.ie+35318034831
clinicaltrials@argenx.com
cancerclinicaltrials@stjames.ie+35314103756
eros.dibona@aulss7.veneto.it+390424889434
carraiv@aou-careggi.toscana.it+390557949183
Andrea.artoni@policlinico.mi.it+390255035280
clinicaltrials@argenx.com
bruno.fattizzo@policlinico.mi.it+390255033477
clinicaltrials@argenx.com
Monica.carpenedo@ospedaleniguarda.it+390264442668
andrea.patriarca@uniupo.it+3903213733092
claudia.cellini@auslromagna.it+390544285752
Barbara.Gamberi@ausl.re.it+390522296626
clinicaltrials@argenx.com
aborchiellini@cittadellasalute.to.it+390116335329
psivera@mauriziano.it+390115082224
francesco.zaja@asugi.sanita.fvg.it+390403992015
domenica.caramazza@asst-settelaghi.it+39332278115
clinicaltrials@argenx.com
marta.sobas@cm.umk.pl+48795149026
kontakt.onkologia.katowice@pratia.com+48501714019
Sekretariat.hemat@kopernik.lodz.pl+48426895191
clinicaltrials@argenx.com
gromek.neuromed@gmail.com+48791430975
clinicaltrials@argenx.com
mmorawska79@gmail.com+48814485180
szf@wp.pl+48501079942
clinicaltrials@argenx.com
hematologia@wszz.torun.pl+48566793745
Carloscapela@med.uminho.pt+351253027100
teresa.lencastre@ulsge.min-saude.pt+351227865100
secretariat@coltea.ro+0213874100
clinicaltrials@argenx.com
secretariat@spitalulcolentina.ro+0213173245
clinicaltrials@argenx.com
secretariat@scjus.ro+0269215050
clinicaltrials@argenx.com
secretariat@spitalmures.ro+0372653100
clinicaltrials@argenx.com
mirjanamitrovic777@gmail.com+381 63 314 278
daziv81@yahoo.com381641437733
tijanic.ivan@yahoo.com381641198028
zcvetkovic06@gmail.com381641302624
nebojsavrajic@gmail.com381638342859
clinicaltrials@argenx.com
Michael.Calvino.Suarez@sergas.es+34981178000
snovelli@iconcologia.net+34932607733
clinicaltrials@argenx.com
jljimenez@salud.madrid.org+34913368367
mllozano@um.es+34968360900
aranzazu.alonso@quironsalud.es+34914521900
marisacalabuig@yahoo.es+34961973500
hayley.ellis@uhb.nhs.uk44 121 371 4351
Stephen.Cox@bthft.nhs.uk441274383383
clinicaltrials@argenx.com
benjamin.bailiff@uhcw.nhs.uk+44 2476 967151
Jane.Ireland@nhs.scot441412013770
vernadine.roque@mhs.net+44 1162584739
s.mamsa@nhs.net+44 2032460261
tung.le1@nhs.net+44 20 331 35711
rch-tr.HaematologyTrials@nhs.net+44 1872 253075