Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT04280718 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod PH20 SC
Study Locations (20)
Florida
- Investigator site 0010072 — Boca Raton
- Investigator site 0010144 — Coral Springs
- Investigator site 0010023 — Jacksonville
- Investigator site 0010068 — Maitland
- Investigator site 0010059 — Miami
- Investigator site 0010006 — Tampa
California
- Investigator site 0010032 — Carlsbad
- Investigator site 10190 — Pomona
- Investigator site 0010160 — Rancho Mirage
- Investigator site 0010071 — San Francisco
Arizona
- Investigator site 0010013 — Phoenix
- Investigator site 0010055 — Scottsdale
Alabama
- Investigator site 0010065 — Birmingham
Colorado
- Investigator site 0010057 — Centennial
Iowa
- Investigator site 0010011 — Iowa City
Kansas
- Investigator site 0010015 — Fairway
Kentucky
- Investigator site 10147 — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2020-09-18 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04280718
The ClinicalTrials.gov registry entry for NCT04280718 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) appearing as the primary indexed condition, and to 1 intervention — of which Efgartigimod PH20 SC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04280718 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04280718 about?
NCT04280718 is a clinical study titled "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)". 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 exp...
What is the current status of trial NCT04280718?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2020-09-18. Estimated completion is 2027-04-30.
What conditions does trial NCT04280718 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04280718?
The interventions under investigation include: Efgartigimod PH20 SC (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04280718?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04280718 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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