Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)NCT04777734
Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and CIDP, run by argenx.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CIDP
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Pre-Approval Access for Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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.
- Being tested
- Efgartigimod PH20 SC
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Subcutaneous administration of Efgartigimod PH20 (via vial or prefilled syringe)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777734
- Sponsor's protocol ID
- ARGX-113-PAA-2403
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Approval Access for Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT04777734
- Acronym / sponsor ID
- ARGX-113-PAA-2403
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod PH20 SCSubcutaneous administration of Efgartigimod PH20 (via vial or prefilled syringe) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and CIDP, run by argenx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.