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Looking for participantsPhase3

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

Sponsor: argenx

NCT ID: NCT06920004

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
empasiprubart (biological), IVIg (biological), empasiprubart-placebo (other), IVIg-placebo (other)
How long the study runs
Study runs about 61 months (dates as stated)
About the drug or intervention
empasiprubart — biological: Intravenous infusion of empasiprubart · IVIg — biological: Intravenous infusion of IVIg · empasiprubart-placebo — other: A placebo resembling the empasiprubart treatment · IVIg-placebo — other: A placebo resembling the IVIg treatment
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
218
Started
2025-08-22
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic inflammatory demyelinating polyneuropathy
  • • Phase3 - 218 participants
  • • The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic inflammatory demyelinating polyneuropathy

Where?

  • • Salford - Salford Royal Hospital - PPDS
  • • Leeds - Leeds General Infirmary
  • • London - The National Hospital for Neurology and Neurosurgery - PPDS

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emvigorate

Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • ✓Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner...
  • ✓Has responded to IVIg in the past 5 years
  • ✓Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose...
  • ✓Has residual disability and active disease

Who cannot take part

  • ✗Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • ✗Use of other long-acting immunomodulatory treatment
See the full criteria
Inclusion Criteria: * Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP * Has responded to IVIg in the past 5 years * Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg * Has residual disability and active disease 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, including polyneuropathy of other causes * Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Use of other long-acting immunomodulatory treatment

Where Is This Study? (3 UK sites)

Salford Royal Hospital - PPDS

Salford M6 8HD, United Kingdom

Recruiting
Site contact (verified)

Leeds General Infirmary

Leeds LS1 3EX, United Kingdom

Recruiting
Site contact (verified)
Priya Shanmugarajah, MDpriya.shanmugarajah@nhs.net

The National Hospital for Neurology and Neurosurgery - PPDS

London WC1N 3BG, United Kingdom

Recruiting
Site contact (verified)
Junie (Shiwen) Koay, MDshiwen.koay@nhs.net

How to Get in Touch

Sabine Coppieters, MD

Sponsor contact

CONTACT

857-350-4834 clinicaltrials@argenx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09