Recruiting

Efgartigimod

Sponsor:

argenx

Code:

NCT07264426

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

CIDP

CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod PH20 SC

Study Details

Brief summary:

The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.

As this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.

Each participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

CIDP

CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Study ID

NCT07264426

Start date

Aug 11, 2025

Status verified date

Apr, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged ≥18 years at time of providing informed consent
  • Diagnosed with CIDP
  • Planned to be receiving efgartigimod treatment within the CIDP treatment label of efgartigimod in the participant's respective country
  • Efgartigimod treatment-naïve at time of screening

Exclusion Criteria:

  • Polyradiculoneuropathy due to any other cause(s)
  • Current participation in any interventional clinical study at time of screening, or planned participation before initiation of efgartigimod

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Efgartigimod PH20 SC

Efgartigimod treatment per country-specific label for the treatment of CIDP

Primary outcome measure

  • Change in aINCAT score over time [ Time Frame: Up to 2 years and 3 months ]
  • Change in I-RODS score over time [ Time Frame: Up to 2 years and 3 months ]
  • Change in grip strength over time [ Time Frame: Up to 2 years and 3 months ]
  • Change in EQ-5D value from index date over time [ Time Frame: Up to 2 years and 3 months ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

PPD Virtual

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

Neil Brett, MD

857-350-4834clinicaltrials@argenx.com

More Information

Sponsor

argenx

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-04-23.