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)

Running, not enrolling · Phase 2

Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

In brief

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.

Key facts

Study ID: NCT04280718
Run by: argenx
People needed: 229
Starts: 2020-09-18
Expected to finish: 2027-04-30
Last updated by the study team: 2025-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.
Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.

You may not qualify if…

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.
Pregnant and lactating women and those intending to become pregnant during the trial.
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.

Where it is running

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 0010065 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.