Clinical trial NCT06920004: A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Reduction of ≥1 point compared with baseline in aINCAT score at week 24
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Change from baseline in I-RODS centile points score at week 24
timeFrame: up to 24 weeks
measure: Change from baseline in MRC-SS at week 24
timeFrame: up to 24 weeks
measure: Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
timeFrame: up to 24 weeks
measure: Time to reduction of ≥1 point from baseline in aINCAT score
timeFrame: up to 24 weeks
measure: Change from baseline in TUG at week 24
timeFrame: up to 24 weeks
measure: Time to increase of ≥1 point compared with baseline in aINCAT score
timeFrame: Up to 24 weeks
measure: Change from baseline in grip strength (3-day moving average) of both hands over time
timeFrame: up to 24 weeks + 96 weeks (Part B)
measure: Change from baseline in grip strength (daily average) for both hands
timeFrame: up to 24 weeks + 96 weeks (Part B)
measure: Change from baseline in MRC-SS over time
timeFrame: up to 96 weeks (Part B)
measure: Change from baseline in aINCAT over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Change from baseline in EQ-5D-5L over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Change from baseline in RT-FSS over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Change from baseline in SF-12 over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Change from baseline in BPI-SF over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: PGI-S values over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: PGI-C values over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Values for work-related and household chore activities of the HRPQ
timeFrame: up to 24 weeks
measure: Percentage of scheduled hours lost in total (absenteeism+ presenteeism)
timeFrame: up to 24 weeks
measure: Change from baseline in I-RODS centile points score over time
timeFrame: Up to 96 weeks (Part B)
measure: Change from baseline in TUG over time
timeFrame: Up to 96 weeks (Part B)
measure: Incidence of antidrug antibodies against empasiprubart in serum
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Incidence of neutralizing antibodies against empasiprubart in serum
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Incidence of (serious) adverse events
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Percentage change from baseline in free C2 and total C2 over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
measure: Serum concentrations of empasiprubart over time
timeFrame: up to 24 weeks (Part A) + 96 weeks (Part B)
Other outcomes:
Locations:
Study officials:
References: