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NCT04812925

PHASE3

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Sponsor: argenx

View on ClinicalTrials.gov

Summary

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

Official title: A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

173

Start Date

2021-11-17

Completion Date

2026-10-01

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Primary Immune Thrombocytopenia

Interventions

BIOLOGICAL

efgartigimod PH20 SC

Subcutaneous injection with efgartigimod PH20 SC

Inclusion Criteria: 1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits). 2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case. 3a. Agree to use contraceptives consistent with local regulations and the following: • Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply: 4\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 5\. Participant has completed a 52-week treatment period. Exclusion criteria: 1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines) 2. Use of any other investigational drug or participation in any other investigational trial 3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients 4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

Locations (83)

Investigator Site 0010116

Bentonville, Arkansas, United States

Investigator site 0010045

Washington D.C., District of Columbia, United States

Investigator Site 0010062

Fort Wayne, Indiana, United States

Investigator site US0010042

Iowa City, Iowa, United States

Investigator Site 0010095

Oklahoma City, Oklahoma, United States

Investigator Site 0540001

Buenos Aires, Argentina

Investigator site 540004

Buenos Aires, Argentina

Investigator Site 0610012

Garran, Australia

Investigator Site 0610003

West Perth, Australia

Investigator site 610005

Westmead, Australia

Investigator Site 3590017

Plovdiv, Bulgaria

Investigator site 0560003

Reñaca, Chile

Investigator site 560002

Santiago, Chile

Investigator site 0560004

Temuco, Chile

Investigator site 860013

Beijing, China

Investigator Site 0860008

Bengbu, China

Investigator site 860055

Huizhou, China

Investigator Site 0860015

Shenzhen, China

Investigator Site 0860001

Tianjin, China

Investigator Site 0860010

Wuhan, China

Investigator Site 0860002

Wuxi, China

Investigator Site 0860011

Zhengzhou, China

Investigator site 860058

Zhenjiang, China

Investigator Site 9950007

Tbilisi, Georgia

Investigator site 9950009

Tbilisi, Georgia

Investigator site 9950011

Tbilisi, Georgia

Investigator site 300008

Athens, Greece

Investigator Site 0300009

Thessaloniki, Greece

Investigator site 3530003

Dublin, Ireland

Investigator site 390043

Ferrara, Italy

Investigator Site 0390032

Milan, Italy

Investigator Site 0390044

Naples, Italy

Investigator site 390041

Naples, Italy

Investigator site JP0810015

Hirakata, Japan

Investigator Site 0810017

Iruma, Japan

Investigator Site 0810053

Kanagawa, Japan

Investigator Site 0810051

Kitakyushu, Japan

Investigator site 0810016

Shibukawa, Japan

Investigator site 810023

Shimotsuke, Japan

Investigator Site 0810038

Tama, Japan

Investigator site 9620001

Irbid, Jordan

Investigator site 520002

Aguascalientes, Mexico

Investigator site 640005

Christchurch, New Zealand

Investigator site 0470003

Sarpsborg, Norway

Investigator site PL0480013

Katowice, Poland

Investigator Site 0480026

Nowy Sącz, Poland

Investigator Site 0480037

Skorzewo, Poland

Investigator Site 3510007

Lisbon, Portugal

Investigator site 3510004

Porto, Portugal

Investigator site 3510001

Vila Nova de Gaia, Portugal

Investigator Site 0400005

Bucharest, Romania

Investigator site 400012

Bucharest, Romania

Investigator Site 0400007

Craiova, Romania

Investigator site 0070040

Kirov, Russia

Investigator Site 0070026

Moscow, Russia

Investigator Site 0070038

Nizhny Novgorod, Russia

Investigator Site 0070037

Novosibirsk, Russia

Investigator site 270003

Johannesburg, South Africa

Investigator site 270004

Observatory, South Africa

Investigator site 270001

Pretoria, South Africa

Investigator site 270002

Randburg, South Africa

Investigator site 820004

Seoul, South Korea

Investigator site KO0820007

Seoul, South Korea

Investigator Site 0660002

Bangkok, Thailand

Investigator Site 0660003

Bangkok, Thailand

Investigator site 660005

Bangkok, Thailand

Investigator Site 0660001

Bangkok Noi, Thailand

Investigator site 0660004

Chiang Mai, Thailand

Investigator site TH0660009

Khon Kaen, Thailand

Investigator site 2610001

Sousse, Tunisia

Investigator site 2160002

Tunis, Tunisia

Investigator Site 0900007

Adapazarı, Turkey (Türkiye)

Investigator Site 0900003

Ankara, Turkey (Türkiye)

Investigator Site 0900008

Ankara, Turkey (Türkiye)

Investigator Site 0900015

Ankara, Turkey (Türkiye)

Investigator site 900004

Izmir, Turkey (Türkiye)

Investigator Site 0900014

Kocaeli, Turkey (Türkiye)

Investigator site 900010

Mersin, Turkey (Türkiye)

Investigator site 0900017

Tekirdağ, Turkey (Türkiye)

Investigator site 900019

Trabzon, Turkey (Türkiye)

Investigator site 440005

Coventry, United Kingdom

Investigator site UK044041

London, United Kingdom

Investigator site UK0440014

Penzance, United Kingdom

Clinical Research Directory

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (83)