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ACTIVE NOT RECRUITING

NCT04280718

PHASE2

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Sponsor: argenx

View on ClinicalTrials.gov

Summary

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Official title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

229

Start Date

2020-09-18

Completion Date

2027-04-30

Last Updated

2025-06-29

Healthy Volunteers

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

Subcutaneous administration of efgartigimod

Inclusion Criteria: 1. Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial. 2. Male or female patient with one of the following options: * Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or * Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or * Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or * Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment. 3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration. 4. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP. Exclusion Criteria: 1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP. 2. Pregnant and lactating women and those intending to become pregnant during the trial. 3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.

Locations (147)

Investigator site 0010065

Birmingham, Alabama, United States

Investigator site 0010013

Phoenix, Arizona, United States

Investigator site 0010055

Scottsdale, Arizona, United States

Investigator site 0010032

Carlsbad, California, United States

Investigator site 10190

Pomona, California, United States

Investigator site 0010160

Rancho Mirage, California, United States

Investigator site 0010071

San Francisco, California, United States

Investigator site 0010057

Centennial, Colorado, United States

Investigator site 0010072

Boca Raton, Florida, United States

Investigator site 0010144

Coral Springs, Florida, United States

Investigator site 0010023

Jacksonville, Florida, United States

Investigator site 0010068

Maitland, Florida, United States

Investigator site 0010059

Miami, Florida, United States

Investigator site 0010006

Tampa, Florida, United States

Investigator site 0010011

Iowa City, Iowa, United States

Investigator site 0010015

Fairway, Kansas, United States

Investigator site 10147

Lexington, Kentucky, United States

Investigator site 10168

New York, New York, United States

Investigator site 0010003

Chapel Hill, North Carolina, United States

Investigator site 0010064

Columbus, Ohio, United States

Investigator site 0010007

Philadelphia, Pennsylvania, United States

Investigator site 0010047

Philadelphia, Pennsylvania, United States

Investigator Site 0010066

Austin, Texas, United States

Investigator site 0010009

San Antonio, Texas, United States

Investigator site 0010061

Richmond, Virginia, United States

Investigator site 0430007

Innsbruck, Austria

Investigator site 0430008

Linz, Austria

Investigator site 0430005

Vienna, Austria

Investigator site 0320016

Edegem, Belgium

Investigator site 0320009

Leuven, Belgium

Investigator site 320024

Liège, Belgium

Investigator site 320022

Woluwe-Saint-Lambert, Belgium

Investigator site 3590007

Pleven, Bulgaria

Investigator site 3590005

Sofia, Bulgaria

Investigator site 3590008

Sofia, Bulgaria

Investigator site 3590006

Sofia, Bulgaria

Investigator site 0860033

Beijing, China

Investigator site 860041

Changsha, China

Investigator site 0860036

Chengdu, China

Investigator site 860049

Chifeng, China

Investigator site 0860038

Fuzhou, China

Investigator site 0860050

Guangzhou, China

Investigator site 0860032

Guanzhou, China

Investigator site 0860045

Guiyang, China

Investigator site 0860035

Hangzhou, China

Investigator site 0860031

Jinan, China

Investigator site 0860040

Nanchang, China

Investigator site 0860043

Nanjing, China

Investigator site 0860028

Shanghai, China

Investigator site 860047

Shanghai, China

Investigator site 0860042

Tianjin, China

Investigator site 0860034

Wuhan, China

Investigator site 0860029

Wuhan, China

Investigator site 0860048

Xi'an, China

Investigator site 0860054

Xianyang, China

Investigator site 4200010

Hradec Králové, Czechia

Investigator site 0450002

Aarhus, Denmark

Investigator site 0450001

Copenhagen, Denmark

Investigator site 0450003

Odense, Denmark

Investigator site 00330034

Angers, France

Investigator site 0330013

Bordeaux, France

Investigator site 330033

Clermont-Ferrand, France

Investigator site 0330023

Le Kremlin-Bicêtre, France

Investigator site 0330024

Limoges, France

Investigator site 330022

Nantes, France

Investigator site 0330021

Nice, France

Investigator site 0330035

Paris, France

Investigator site 0330020

Strasbourg, France

Investigator site 9950020

Kutaisi, Georgia

Investigator site 9950004

Tbilisi, Georgia

Investigator site 9950005

Tbilisi, Georgia

Investigator site 9950002

Tbilisi, Georgia

Investigator Site 9950003

Tbilisi, Georgia

Investigator site 490044

Bochum, Germany

Investigator site 0490013

Cologne, Germany

Investigator site 490045

Essen, Germany

Investigator site 490021

Göttingen, Germany

Investigator site 0490016

Kiel, Germany

Investigator site 0490019

Potsdam, Germany

Investigator site 9720004

Tel Aviv, Israel

Investigator site 0390022

Brescia, Italy

Investigator site 390029

Florence, Italy

Investigator site 0390024

Genova, Italy

Investigator site 390027

Messina, Italy

Investigator site 0390003

Milan, Italy

Investigator site 0390026

Milan, Italy

Investigator site 0390023

Pisa, Italy

Investigator site 0390008

Roma, Italy

Investigator site 0390042

Torino, Italy

Investigator site 0810035

Bunkyō City, Japan

Investigator site 0810002

Chiba, Japan

Investigator site 0810030

Fuchū, Japan

Investigator site 0810031

Fukuoka, Japan

Investigator site 0810065

Ginowan, Japan

Investigator site 0810066

Hakodate, Japan

Investigator site 0810058

Hiroshima, Japan

Investigator site 0810029

Kawagoe, Japan

Investigator site 0810026

Kodaira, Japan

Investigator site 810061

Kyoto, Japan

Investigator site 0810027

Mibu, Japan

Investigator site 0810032

Nagoya, Japan

Investigator site 0810003

Osaka, Japan

Investigator site 0810007

Osaka, Japan

Investigator site 0810063

Suita, Japan

Investigator site 0810036

tabashi City, Japan

Investigator site 0810064

Tokushima, Japan

Investigator site 0810060

Yokohama, Japan

Investigator site 31

Riga, Latvia

Investigator site 0310010

Amsterdam, Netherlands

Investigator site 0310011

Rotterdam, Netherlands

Investigator site 0480024

Krakow, Poland

Investigator site 0480018

Krakow, Poland

Investigator site 0480020

Lodz, Poland

Investigator Site 0480017

Lublin, Poland

Investigator site 0480022

Warsaw, Poland

Investigator site 040002

Brasov, Romania

Investigator site 040001

Bucharest, Romania

Investigator site 040004

Constanța, Romania

Investigator site 040003

Timișoara, Romania

Investigator site 070017

Kazan', Russia

Investigator site 0070023

Kazan', Russia

Investigator site 0070020

Moscow, Russia

Investigator site 70021

Moscow, Russia

Investigator site 0070019

Rostov-on-Don, Russia

Investigator site 0070014

Saint Petersburg, Russia

Investigator site 0070021

Saransk, Russia

Investigator site 3810001

Belgrade, Serbia

Investigator site 3810003

Belgrade, Serbia

Investigator site 3810004

Kragujevac, Serbia

Investigator site 0340021

Badalona, Spain

Investigator site 0340038

Barcelona, Spain

Investigator site 0340018

Madrid, Spain

Investigator site 8860013

Tainan, Taiwan

Investigator site 8860012

Taipei, Taiwan

Investigator site 8860016

Taipei, Taiwan

Investigator site 8860017

Taoyuan District, Taiwan

Investigator site 900025

Bursa, Turkey (Türkiye)

Investigator site 900021

Izmir, Turkey (Türkiye)

Investigator site 900022

Samsun, Turkey (Türkiye)

Investigator Site 3800012

Dnipro, Ukraine

Investigator Site 3800010

Ivano-Frankivsk, Ukraine

Investigator site 3100013

Kyiv, Ukraine

Investigator site 3800008

Lutsk, Ukraine

Investigator site 3800011

Zaporizhzhya, Ukraine

Investigator site 440026

London, United Kingdom

Investigator site 0440016

Oxford, United Kingdom

Investigator site 0440018

Sheffield, United Kingdom

Clinical Research Directory

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (147)