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

NCT06920004 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ARGX-117-24012024-520097-36-00
• Study Type: interventional
• Target: 218
• Locations: 23 countries
• Sites: 70

Brief Summary

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Reduction of ≥1 point compared with baseline in aINCAT score at week 24

  The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  up to 24 weeks

Secondary Outcomes (25)

• Change from baseline in I-RODS centile points score at week 24

  up to 24 weeks

• Change from baseline in MRC-SS at week 24

  up to 24 weeks

• Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24

  up to 24 weeks

• Time to reduction of ≥1 point from baseline in aINCAT score

  up to 24 weeks

• Change from baseline in TUG at week 24

  up to 24 weeks

Study Arms (3)

Part A - empasiprubart + IVIg-placebo

EXPERIMENTAL

During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.

Biological: empasiprubart; Other: IVIg-placebo

Part A - IVIg + empasiprubart-placebo

ACTIVE COMPARATOR

During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.

Biological: IVIg; Other: empasiprubart-placebo

Part B - empasiprubart

EXPERIMENTAL

After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.

Biological: empasiprubart; Other: empasiprubart-placebo

Interventions

IVIg BIOLOGICAL

Intravenous infusion of IVIg

Part A - IVIg + empasiprubart-placebo

empasiprubart-placebo OTHER

A placebo resembling the empasiprubart treatment

Part A - IVIg + empasiprubart-placebo; Part B - empasiprubart

IVIg-placebo OTHER

A placebo resembling the IVIg treatment

Part A - empasiprubart + IVIg-placebo

empasiprubart BIOLOGICAL

Intravenous infusion of empasiprubart

Part A - empasiprubart + IVIg-placebo; Part B - empasiprubart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (75)

Samir Macwan, M.D., Inc.

Rancho Mirage, California, 922701, United States

RECRUITING

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Homestead Associates in Research Inc

Homestead, Florida, 33033, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

University of South Florida

Tampa, Florida, 33616, United States

RECRUITING

Paradigm Health System

Slidell, Louisiana, 70458, United States

RECRUITING

Erlanger Health System

Columbia, Maryland, 21044, United States

RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

NeuroCarePlus

Houston, Texas, 77094, United States

RECRUITING

National Neuromuscular Research Institute

Irving, Texas, 75063, United States

RECRUITING

INECO Neurociencias Oroño

Rosario, S2000DTP, Argentina

RECRUITING

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

RECRUITING

Fakultni nemocnice Brno

Brno, Czechia

RECRUITING

Astra Kliinik

Tallinn, 11315, Estonia

RECRUITING

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

AP-HP - Hôpital de la Pitié Salpétrière

Paris, Paris, 75013, France

ACTIVE NOT RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

CHU de Nice-Hôpital Pasteur

Nice, 6001, France

RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200, France

RECRUITING

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, 31059, France

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

RECRUITING

University General Hospital of Alexandroupolis

Athens, 15562, Greece

RECRUITING

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

Chaïdári, 124 62, Greece

RECRUITING

The Barzilai University Medical Center

Ashkelon, 78278, Israel

RECRUITING

Hadassah Medical Center- Ein Kerem

Jerusalem, 9112001, Israel

RECRUITING

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

AUSL di Bologna - Ospedale Bellaria

Bologna, 40139, Italy

RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, 161, Italy

RECRUITING

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

RECRUITING

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

RECRUITING

Chiba University Hospital

Chūōku, 260-8677, Japan

RECRUITING

Juntendo Shizuoka University Hospital

Izunokuni, 410-2295, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

RECRUITING

Saga University Hospital

Saga, 849-8501, Japan

RECRUITING

General Hospital Tsuchiura Kyodo Hospital

Tsuchiura, 300-0028, Japan

RECRUITING

Yamaguchi University Hospital

Ube, 755-0067, Japan

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Oslo Universitetssykehus HF, Ullevål

Oslo, 450, Norway

RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065, Poland

RECRUITING

Neurocentrum Bydgoszcz

Bydgoszcz, 85-796, Poland

RECRUITING

Centrum Medyczne Neurologia Slaska

Katowice, 40-689, Poland

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

RECRUITING

Centrum Medyczne Linden

Krakow, 30-721, Poland

RECRUITING

Galen Clinic - Lublin

Lublin, 20-064, Poland

RECRUITING

Clinical Research Center Sp. z o.o. Medic-R sp.k.

Poznan, 61-731, Poland

RECRUITING

Centrum Medyczne Medyk

Rzeszów, 35-210, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie

Szczecin, 71-252, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 1

Szczecin, 71-252, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, 02-097, Poland

RECRUITING

ULS de Santo António, EPE - Hospital de Santo António

Porto, 4050-342, Portugal

RECRUITING

Institutul National de Neurologie si Boli Neurovasculare Bucuresti

Bucharest, 41914, Romania

RECRUITING

Brainaxy Clinic SRL

Constanța, 900348, Romania

RECRUITING

Targu-Mures Emergency Clinical County Hospital

Târgu Mureş, 540136, Romania

RECRUITING

University Clinical Center of Serbia - Dr Subotica 6

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center Nis

Niš, 18 000, Serbia

RECRUITING

National Neuroscience Institute

Singapore, 308433, Singapore

RECRUITING

Univerzitna nemocnica MARTIN

Martin, 036 59, Slovakia

RECRUITING

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

University Clinical Centre Maribor

Maribor, 2000, Slovenia

RECRUITING

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, 05030, South Korea

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Sant Andreu de la Barca, 08740, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41346, Sweden

RECRUITING

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205, Switzerland

RECRUITING

Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

Samsun, 55200, Turkey (Türkiye)

RECRUITING

Salford Royal Hospital - PPDS

Salford, Lancashire, M6 8HD, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); AU (1); IT (4); US (11); KR (4); CZ (1); PL (11); NO (1); RO (3); FR (6); ES (3); GR (2); NL (1); JP (8); DE (2); AR (1); SL (1); TU (1); PT (1); SG (1); IL (3); SE (2); GB (1)