Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
Sponsorargenx
About this trial
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options. The program will continue until the patient discontinues treatment or until the reimbursement process for CIDP concludes, whichever comes first.
Eligibility criteria
Qualifiers
Cannot be included in an ongoing clinical study and cannot be satisfactorily treated with a product that has regulatory approval
Is ≥18 years of age at the time of signing the informed consent form
Patient has a diagnosis of CIDP according to the 2021 EAN/PNS CIDP guidelines
Patient has progressive or relapsing active disease after prior treatment with corticosteroids or immunoglobulins
Disqualifiers
Known autoimmune disease or any medical condition that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of CIDP or that puts the patient at undue risk
Is currently being treated or plans to start treatment with monoclonal antibodies or treatments that contain the human Fc domain of the IgG subclass
Pregnant or lactating state or intention to become pregnant during the program
Trial design
Treatments tested in this trial
- Efgartigimod PH20 SC
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov