A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Last updated: June 25, 2024
Sponsor: argenx
Overall Status: Active - Not Recruiting

Phase

3

Condition

Platelet Disorders

Immune Thrombocytopenia (Itp)

Idiopathic Thrombocytopenic Purpura (Itp)

Treatment

efgartigimod

Clinical Study ID

NCT04225156
ARGX-113-1803
2019-002101-21
  • Ages > 18
  • All Genders

Study Summary

This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Ability to understand the requirements of the trial, to provide written informedconsent (including consent for the use and disclosure of research-related healthinformation), and to comply with the trial protocol procedures (including requiredtrial visits).

  2. Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trialperiod.

  3. Women of childbearing potential must have a negative urine pregnancy test atbaseline before trial medication (infusion) can be administered.

  4. Women of childbearing potential should use a highly effective or acceptable methodof contraception during the trial and for 90 days after the last administration ofthe IMP. They must be on a stable regimen, for at least 1 month (as listed in theprotocol)

  5. Ability to understand the requirements of the additional 52-week treatment period ofthe trial, to provide written informed consent (including consent for the use anddisclosure of research-related health information), and to comply with the trialprotocol procedures (including required trial visits).

  6. Patient has completed a 52-week treatment period.

Exclusion

Exclusion criteria:

  1. Introduction or continuation of non-permitted medications during the ARGX-113-1801trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusionproteins or live/live-attenuated vaccines).

  2. Pregnant or lactating women, and those intending to become pregnant during the trialor within 90 days after the last dosing.

  3. Patients with known medical history of hypersensitivity to any of the ingredients ofefgartigimod.

  4. Use of any other investigational drug or participation in any other investigationaltrial.

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: efgartigimod
Phase: 3
Study Start date:
June 02, 2020
Estimated Completion Date:
November 14, 2026

Connect with a study center

  • Investigator Site 0430002

    Vienna,
    Austria

    Site Not Available

  • Investigator Site 0430003

    Vienna,
    Austria

    Site Not Available

  • Investigator Site 0320012

    Brasschaat,
    Belgium

    Site Not Available

  • Investigator Site 0320011

    Brugge,
    Belgium

    Site Not Available

  • Investigator Site 0320014

    Turnhout,
    Belgium

    Site Not Available

  • Investigator Site 0320002

    Yvoir,
    Belgium

    Site Not Available

  • Investigator Site 3590001

    Pleven,
    Bulgaria

    Site Not Available

  • Investigator Site 3590002

    Sofia,
    Bulgaria

    Site Not Available

  • Investigator Site 4200001

    Brno,
    Czechia

    Site Not Available

  • Investigator Site 4200008

    Olomouc,
    Czechia

    Site Not Available

  • Investigator Site 4200006

    Ostrava,
    Czechia

    Site Not Available

  • Investigator Site 4200007

    Praha,
    Czechia

    Site Not Available

  • Investigator Site 0330009

    Créteil,
    France

    Site Not Available

  • Investigator Site 0330018

    Montpellier,
    France

    Site Not Available

  • Investigator Site 0330008

    Pessac,
    France

    Site Not Available

  • Investigator Site 0330016

    Périgueux,
    France

    Site Not Available

  • Investigator site 9950007

    Tbilisi,
    Georgia

    Site Not Available

  • Investigator site 9950008

    Tbilisi,
    Georgia

    Site Not Available

  • Investigator site 9950009

    Tbilisi,
    Georgia

    Site Not Available

  • Investigator site 9950011

    Tbilisi,
    Georgia

    Site Not Available

  • Investigator site 9950012

    Tbilisi,
    Georgia

    Site Not Available

  • Investigator Site 0490010

    Düsseldorf,
    Germany

    Site Not Available

  • Investigator Site 0490008

    Essen,
    Germany

    Site Not Available

  • Investigator Site 0360004

    Budapest,
    Hungary

    Site Not Available

  • Investigator Site 0360006

    Debrecen,
    Hungary

    Site Not Available

  • Investigator Site 0360015

    Győr,
    Hungary

    Site Not Available

  • Investigator Site 7

    Nyiregyhaza,
    Hungary

    Site Not Available

  • Investigator Site 0360010

    Nyíregyháza,
    Hungary

    Site Not Available

  • Investigator Site 0360014

    Szombathely,
    Hungary

    Site Not Available

  • Investigator Site 0390014

    Milano,
    Italy

    Site Not Available

  • Investigator Site 0390020

    Monza,
    Italy

    Site Not Available

  • Investigator Site 0390015

    Novara,
    Italy

    Site Not Available

  • Investigator Site 0390010

    Ravenna,
    Italy

    Site Not Available

  • Investigator Site 0390011

    Reggio Calabria,
    Italy

    Site Not Available

  • Investigator Site 0390018

    Reggio Emilia,
    Italy

    Site Not Available

  • Investigator Site 0390019

    Rimini,
    Italy

    Site Not Available

  • Investigator Site 0390009

    Siena,
    Italy

    Site Not Available

  • Investigator Site 0390016

    Trieste,
    Italy

    Site Not Available

  • Investigator Site 15

    Gunma,
    Japan

    Site Not Available

  • Investigator Site 0810015

    Hirakata,
    Japan

    Site Not Available

  • Investigator Site 0810010

    Hiroshima,
    Japan

    Site Not Available

  • Investigator Site 16

    Hokkaido,
    Japan

    Site Not Available

  • Investigator Site 0810017

    Iruma,
    Japan

    Site Not Available

  • Investigator Site 0810022

    Kashiwa,
    Japan

    Site Not Available

  • Investigator Site 0810018

    Maebashi,
    Japan

    Site Not Available

  • Investigator Site 0810021

    Niigata,
    Japan

    Site Not Available

  • Investigator Site 13

    Saitama,
    Japan

    Site Not Available

  • Investigator Site 0810014

    Sapporo,
    Japan

    Site Not Available

  • Investigator Site 0810016

    Shibukawa,
    Japan

    Site Not Available

  • Investigator Site 0810023

    Shimotsuke,
    Japan

    Site Not Available

  • Investigator Site 14

    Tochigi,
    Japan

    Site Not Available

  • Investigator Site 0310006

    Den Haag,
    Netherlands

    Site Not Available

  • Investigator Site 0310005

    Rotterdam,
    Netherlands

    Site Not Available

  • Investigator Site 0480012

    Gdańsk,
    Poland

    Site Not Available

  • Investigator Site 0480013

    Katowice,
    Poland

    Site Not Available

  • Investigator Site 0480014

    Lublin,
    Poland

    Site Not Available

  • Investigator Site 0480026

    Nowy Sącz,
    Poland

    Site Not Available

  • Investigator Site 0480011

    Łódź,
    Poland

    Site Not Available

  • Investigator Site 0070006

    Kaluga,
    Russian Federation

    Site Not Available

  • Investigator Site 0070008

    Moscow,
    Russian Federation

    Site Not Available

  • Investigator Site 0070007

    Petrozavodsk,
    Russian Federation

    Site Not Available

  • Investigator Site 0070013

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Investigator Site 0070009

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Investigator Site 0070015

    Syktyvkar,
    Russian Federation

    Site Not Available

  • Investigator Site 0070012

    Tula,
    Russian Federation

    Site Not Available

  • Investigator Site 0070010

    Ufa,
    Russian Federation

    Site Not Available

  • Investigator Site 0340006

    Barcelona,
    Spain

    Site Not Available

  • Investigator Site 0340007

    Barcelona,
    Spain

    Site Not Available

  • Investigator Site 0340009

    Madrid,
    Spain

    Site Not Available

  • Investigator Site 0340014

    Madrid,
    Spain

    Site Not Available

  • Investigator Site 0340012

    Palma De Mallorca,
    Spain

    Site Not Available

  • Investigator Site 0340015

    Pozuelo De Alarcón,
    Spain

    Site Not Available

  • Investigator Site 0340013

    Sevilla,
    Spain

    Site Not Available

  • Investigator Site 0340004

    Valencia,
    Spain

    Site Not Available

  • Investigator Site 0340011

    Valencia,
    Spain

    Site Not Available

  • Investigator Site 0900003

    Ankara,
    Turkey

    Site Not Available

  • Investigator Site 0900006

    Ankara,
    Turkey

    Site Not Available

  • Investigator Site 0900015

    Ankara,
    Turkey

    Site Not Available

  • Investigator Site 0900016

    Edirne,
    Turkey

    Site Not Available

  • Investigator Site 0900013

    Istanbul,
    Turkey

    Site Not Available

  • Investigator Site 0900010

    Mersin,
    Turkey

    Site Not Available

  • Investigator Site 0900007

    Sakarya,
    Turkey

    Site Not Available

  • Investigator Site 0900009

    Samsun,
    Turkey

    Site Not Available

  • Investigator Site 0900017

    Tekirdağ,
    Turkey

    Site Not Available

  • Investigator Site 0900019

    Trabzon,
    Turkey

    Site Not Available

  • Investigator Site 0900004

    İzmir,
    Turkey

    Site Not Available

  • Investigator Site 3800006

    Mykolaiv,
    Ukraine

    Site Not Available

  • Investigator Site 0440008

    London,
    United Kingdom

    Site Not Available

  • Investigator Site 0440012

    Southampton,
    United Kingdom

    Site Not Available

  • Investigator Site 0010045

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Investigator Site 0010037

    Ocala, Florida 34474
    United States

    Site Not Available

  • Investigator Site 0010042

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Investigator Site 0010040

    Columbus, Ohio 43210
    United States

    Site Not Available

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