Chronic Inflammatory Demyelinating PolyneuropathyPhase 4NCT06637072
A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC
A Phase 4 study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by argenx at 13 sites in United States.
Trial summary
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 13 sitesUnited States
- Study dates
- 10 Dec 2024to 19 Feb 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
National Neuromuscular Research Institute
Austin, Texas, 78759
Erlanger Neuroscience Institute
Chattanooga, Tennessee, 37403
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Horizon Clinical Research: Gill Neuroscience
Cypress, Texas, 21216
Northwest Houston Neurology - Cypress
Cypress, Texas, 77429
Cedar Health Research - Dallas
Dallas, Texas, 75251
Velocity Clinical Research
Lafayette, Louisiana, 70508
Neurology Associates PA
Maitland, Florida, 32751
Visionary Investigators Network
Miami, Florida, 33180
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
SRI International - ClinEdge
Plymouth, Michigan, 48170
Velocity Clinical Research
Raleigh, North Carolina, 27607
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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 will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
- 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 injection of efgartigimod PH20 SC
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants start efgartigimod PH20 SC treatment after discontinuing IVIg Receives: Biological: Efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period
Measured: Up to 12 weeks
Secondary outcomes (5)
Changes from baseline in EQ-5D-5L scores over time
Measured: Up to 12 weeks
Changes from baseline in TSQM-9 scores over time
Measured: Up to 12 weeks
Changes from baseline in PGI-C scores over time
Measured: Up to 12 weeks
Changes from baseline in PGI-S scores over time
Measured: Up to 12 weeks
Incidence of (S)AEs
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Dec 2024
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637072
- Sponsor's protocol ID
- ARGX-113-2406
- Status last verified
- Apr 2026
- First submitted
- 7 Oct 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06637072
- Acronym / sponsor ID
- ARGX-113-2406
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 15 Oct 2024 (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.
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Biological: Efgartigimod PH20 SCParticipants start efgartigimod PH20 SC treatment after discontinuing IVIg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 injection of efgartigimod PH20 SC | Biological | Efgartigimod PH20 SC |
Primary outcome
Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period
Time frame: Up to 12 weeks
5 secondary outcomes
Changes from baseline in EQ-5D-5L scores over time
Time frame: Up to 12 weeks
Changes from baseline in TSQM-9 scores over time
Time frame: Up to 12 weeks
Changes from baseline in PGI-C scores over time
Time frame: Up to 12 weeks
Changes from baseline in PGI-S scores over time
Time frame: Up to 12 weeks
Incidence of (S)AEs
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efgartigimod PH20 SC in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by argenx at 13 sites in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
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 6 Apr 2026.