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)
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)
Incidence of treatment-emergent adverse events and serious adverse events — Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Trial sites (147)
Facility
City
Region
Status
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.
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.
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