Assessing adults with CIDP switching from IVIg to efgartigimod PH20 SC
A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy Who Transition from Treatment with Intravenous Immunoglobulin to Efgartigimod PH20 SC
This study is testing how well adults with CIDP do when they switch from their current IVIg treatment to a new medication called efgartigimod PH20 SC.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Locations | 3 sites (Maitland, Florida and 2 other locations) |
| Trial ID | NCT06637072 on ClinicalTrials.gov |
What this trial studies
This study evaluates how adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) transition from intravenous immunoglobulin (IVIg) treatment to efgartigimod PH20 SC. Participants will be monitored over a period of approximately 17 to 19 weeks to assess their adjustment to the new treatment. The study aims to provide insights into the efficacy and safety of efgartigimod PH20 SC in this patient population. Inclusion criteria require participants to be stable on their current IVIg regimen and meet specific health conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with CIDP who are currently receiving stable IVIg treatment.
Not a fit: Patients with other types of polyneuropathy or those with additional autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with CIDP, potentially improving their quality of life.
How similar studies have performed: While this approach is relatively novel, previous studies on similar treatments have shown promise in managing CIDP.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent * Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society * Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses * If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month. * If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months Exclusion Criteria: * Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk * Types of other polyneuropathy other than CIDP
Where this trial is running
Maitland, Florida and 2 other locations
- Neurology Associates PA — Maitland, Florida, United States (Recruiting)
- Visionary Investigators Network — Miami, Florida, United States (Recruiting)
- National Neuromuscular Research Institute — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.