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

Phase 3RecruitingNCT06920004

argenx218 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

218

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (101)

University of Alabama

Birmingham, Alabama, United States

RECRUITING

Samir Macwan, M.D., Inc.

Rancho Mirage, California, United States

RECRUITING

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

RECRUITING

MedStar Washington Hospital Center

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

Outcomes

Primary Outcomes

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).

Time frame: up to 24 weeks

Secondary Outcomes

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

Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).

Time frame: up to 24 weeks

Change from baseline in MRC-SS at week 24

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

Time frame: up to 24 weeks

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

The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.

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

The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.

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

The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand.

Time frame: up to 24 weeks + 96 weeks (Part B)

Change from baseline in MRC-SS over time

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

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

EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Change from baseline in RT-FSS over time

Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Change from baseline in SF-12 over time

12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Change from baseline in BPI-SF over time

The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

PGI-S values over time

The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

PGI-C values over time

The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment.

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Values for work-related and household chore activities of the HRPQ

The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.

Time frame: up to 24 weeks

Percentage of scheduled hours lost in total (absenteeism+ presenteeism)

Time frame: up to 24 weeks

Change from baseline in I-RODS centile points score over time

Time frame: Up to 96 weeks (Part B)

Change from baseline in TUG over time

Time frame: Up to 96 weeks (Part B)

Incidence of antidrug antibodies against empasiprubart in serum

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Incidence of neutralizing antibodies against empasiprubart in serum

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Incidence of (serious) adverse events

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Percentage change from baseline in free C2 and total C2 over time

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Serum concentrations of empasiprubart over time

Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

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

Overview

Conditions

Interventions

Eligibility

Locations (101)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts