Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
argenx
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2027
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT04280718
Start Date
September 18 2020
End Date
April 30 2027
Last Update
June 29 2025
Active Locations (147)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigator site 0010065
Birmingham, Alabama, United States, 35233-2110
2
Investigator site 0010013
Phoenix, Arizona, United States, 85018
3
Investigator site 0010055
Scottsdale, Arizona, United States, 85028
4
Investigator site 0010032
Carlsbad, California, United States, 92011