Skip to content

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520805-10-00
Enrollment
16
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Brief summary

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

Detailed description

Change from baseline in I-RODS centile points score - up to 24 weeks (part A), Change from baseline in MRC-SS at week 24, Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24, Time to reduction of ≥1 point from baseline in aINCAT score - up to 24 weeks, Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24, Change from baseline in grip strength (3-day moving average) of both hands over time and change from baseline in grip strength (daily average) for both hands, Change from baseline in MRC-SS over time. Up to 96 weeks (Part B), Change from baseline in aINCAT score over time, Change from baseline in EQ-5D-5L over time, Change from baseline in RT-FSS over time, Change from baseline in BPI-SF over time, PGI-S values over time, PGI-C values over time, Incidence and prevalence of ADA against empasiprubart in serum, Incidence and prevalence of NAb against empasiprubart in serum, Incidence and severity of AEs, Incidence of SAEs, Clinically meaningful changes in laboratory parameters, ECG results, and vital signs, Absolute values and percentage change from baseline in free C2 and total C2 over time, Serum concentrations of empasiprubart over time, Reduction of ≥1 point in aINCAT over time, Increase of ≥1 point from baseline in aINCAT over time, Change from baseline in TUG at week 24

Interventions

Sponsors

Argenx
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change from baseline in I-RODS centile points score - up to 24 weeks (part A), Change from baseline in MRC-SS at week 24, Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24, Time to reduction of ≥1 point from baseline in aINCAT score - up to 24 weeks, Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24, Change from baseline in grip strength (3-day moving average) of both hands over time and change from baseline in grip strength (daily average) for both hands, Change from baseline in MRC-SS over time. Up to 96 weeks (Part B), Change from baseline in aINCAT score over time, Change from baseline in EQ-5D-5L over time, Change from baseline in RT-FSS over time, Change from baseline in BPI-SF over time, PGI-S values over time, PGI-C values over time, Incidence and prevalence of ADA against empasiprubart in serum, Incidence and prevalence of NAb against empasiprubart in serum, Incidence and severity of AEs, Incidence of S

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 12, 2026