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Clinical Trials in the UK / NCT04280718
Active, not recruiting Phase 2

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)

NCT04280718 · tracked via the Priya Life Science UK tracker
Sponsor
argenx
Phase
Phase 2
Started
2020-09-18
Last updated
2025-06-29

Condition(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC

Efgartigimod PH20 SC: Subcutaneous administration of efgartigimod

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
Investigator site 0010065 Birmingham Alabama
Investigator site 0010013 Phoenix Arizona
Investigator site 0010055 Scottsdale Arizona
Investigator site 0010032 Carlsbad California
Investigator site 10190 Pomona California
Investigator site 0010160 Rancho Mirage California
Investigator site 0010071 San Francisco California
Investigator site 0010057 Centennial Colorado
Investigator site 0010072 Boca Raton Florida
Investigator site 0010144 Coral Springs Florida
Investigator site 0010023 Jacksonville Florida
Investigator site 0010068 Maitland Florida
Investigator site 0010059 Miami Florida
Investigator site 0010006 Tampa Florida
Investigator site 0010011 Iowa City Iowa
Investigator site 0010015 Fairway Kansas
Investigator site 10147 Lexington Kentucky
Investigator site 10168 New York New York
Investigator site 0010003 Chapel Hill North Carolina
Investigator site 0010064 Columbus Ohio
Investigator site 0010007 Philadelphia Pennsylvania
Investigator site 0010047 Philadelphia Pennsylvania
Investigator Site 0010066 Austin Texas
Investigator site 0010009 San Antonio Texas
Investigator site 0010061 Richmond Virginia
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

+ 107 more sites — see the full list on the official registry below.

More argenx trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04280718 on ClinicalTrials.gov ↗ ← All trials in the UK