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Recruiting NCT06920004

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

Phase III Interventional Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: empasiprubart, IVIg, empasiprubart-placebo, IVIg-placebo.
Who it may be relevant to
Registry conditions: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Austria, Colombia, Czechia +23
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Overview

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

Interventions

  • Biological empasiprubart
    Intravenous infusion of empasiprubart
  • Biological IVIg
    Intravenous infusion of IVIg
  • Other empasiprubart-placebo
    A placebo resembling the empasiprubart treatment
  • Other IVIg-placebo
    A placebo resembling the IVIg treatment

Primary outcome measures

  • Reduction of ≥1 point compared with baseline in aINCAT score at week 24 [Time frame: up to 24 weeks]
Secondary outcome measures (12)
  • Change from baseline in I-RODS centile points score at week 24 [Time frame: up to 24 weeks]
  • Change from baseline in MRC-SS at week 24 [Time frame: up to 24 weeks]
  • Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 [Time frame: up to 24 weeks]
  • Time to reduction of ≥1 point from baseline in aINCAT score [Time frame: up to 24 weeks]
  • Change from baseline in TUG at week 24 [Time frame: up to 24 weeks]
  • Time to increase of ≥1 point compared with baseline in aINCAT score [Time frame: Up to 24 weeks]
  • Change from baseline in grip strength (3-day moving average) of both hands over time [Time frame: up to 24 weeks + 96 weeks (Part B)]
  • Change from baseline in grip strength (daily average) for both hands [Time frame: up to 24 weeks + 96 weeks (Part B)]
  • Change from baseline in MRC-SS over time [Time frame: up to 96 weeks (Part B)]
  • Change from baseline in aINCAT over time [Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)]
  • Change from baseline in EQ-5D-5L over time [Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)]
  • Change from baseline in RT-FSS over time [Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • University of Alabama — Birmingham
  • Samir Macwan, M.D., Inc. — Rancho Mirage
  • Colorado Springs Neurological Associates — Colorado Springs
  • MedStar Washington Hospital Center — Washington D.C.
  • Homestead Associates in Research Inc — Homestead
  • Visionary Investigators Network — Miami
  • University of South Florida — Tampa
  • Paradigm Health System — Slidell
  • … and 4 more centers
Poland · 11 centers
  • MICS Centrum Medyczne Bydgoszcz — Bydgoszcz
  • Neurocentrum Bydgoszcz — Bydgoszcz
  • Centrum Medyczne Neurologia Slaska — Katowice
  • SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow
  • Centrum Medyczne Linden — Krakow
  • Galen Clinic - Lublin — Lublin
  • Clinical Research Center Sp. z o.o. Medic-R sp.k. — Poznan
  • Centrum Medyczne Medyk — Rzeszów
  • … and 3 more centers
Japan · 8 centers
  • Aomori Prefectural Central Hospital — Aomori
  • Juntendo University Hospital — Bunkyō City
  • Chiba University Hospital — Chūōku
  • Juntendo Shizuoka University Hospital — Izunokuni
  • Osaka Metropolitan University Hospital — Osaka
  • Saga University Hospital — Saga
  • General Hospital Tsuchiura Kyodo Hospital — Tsuchiura
  • Yamaguchi University Hospital — Ube
France · 6 centers
  • AP-HP - Hôpital de la Pitié Salpétrière — Paris
  • CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
  • AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre
  • CHU de Nice-Hôpital Pasteur — Nice
  • CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg
  • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan — Toulouse
Italy · 6 centers
  • AUSL di Bologna - Ospedale Bellaria — Bologna
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia
  • Azienda Ospedaliero-Universitaria Sant'Andrea — Roma
  • Fondazione PTV Policlinico Tor Vergata — Roma
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I — Roma
  • IRCCS Istituto Clinico Humanitas — Rozzano
South Korea · 4 centers
  • Inje University Haeundae Paik Hospital — Busan
  • Seoul National University Hospital — Seoul
  • Severance Hospital Yonsei University Health System — Seoul
  • Konkuk University Medical Center — Seoul
Israel · 3 centers
  • The Barzilai University Medical Center — Ashkelon
  • Hadassah Medical Center- Ein Kerem — Jerusalem
  • The Chaim Sheba Medical Center — Tel Litwinsky
Romania · 3 centers
  • Institutul National de Neurologie si Boli Neurovasculare Bucuresti — Bucharest
  • Brainaxy Clinic SRL — Constanța
  • Targu-Mures Emergency Clinical County Hospital — Târgu Mureş
Spain · 3 centers
  • Hospital General Universitario Gregorio Marañon — Madrid
  • Hospital Universitario Vall d'Hebron — Sant Andreu de la Barca
  • Hospital Universitario Virgen Macarena — Seville
Colombia · 2 centers
  • Hospital Universitario San Ignacio — Bogotá
  • Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico — Medellín
Estonia · 2 centers
  • Astra Kliinik — Tallinn
  • Tartu University Hospital — Tartu
Germany · 2 centers
  • Charité - Universitätsmedizin Berlin — Berlin
  • Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel
Greece · 2 centers
  • University General Hospital of Alexandroupolis — Athens
  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Chaïdári
Serbia · 2 centers
  • University Clinical Center of Serbia - Dr Subotica 6 — Belgrade
  • University Clinical Center Nis — Niš
Slovenia · 2 centers
  • University Medical Centre Ljubljana — Ljubljana
  • University Clinical Centre Maribor — Maribor
United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Argentina · 1 center
  • INECO Neurociencias Oroño — Rosario
Austria · 1 center
  • Universitätsklinikum AKH Wien — Vienna
Czechia · 1 center
  • Fakultni nemocnice Brno — Brno
Hungary · 1 center
  • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete — Budapest
Netherlands · 1 center
  • Universitair Medisch Centrum Utrecht — Utrecht
Norway · 1 center
  • Oslo Universitetssykehus HF, Ullevål — Oslo
Portugal · 1 center
  • ULS de Santo António, EPE - Hospital de Santo António — Porto
Singapore · 1 center
  • National Neuroscience Institute — Singapore
Slovakia · 1 center
  • Univerzitna nemocnica MARTIN — Martin
Sweden · 1 center
  • Sahlgrenska University Hospital — Gothenburg
Switzerland · 1 center
  • Hôpitaux Universitaires de Genève (HUG) — Geneva
Turkey (Türkiye) · 1 center
  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi — Samsun

Identifiers

NCT: NCT06920004 · ARGX-117-2401 · 2024-520097-36-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗