A study to assess efficacy and safety of empasiprubart versus IVIg in adults with CIDP ("emvigorate")

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Argenx

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

7 Jan 2026 → ongoing

Decision date (initial)

2025-12-01

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

argenx BV, Belgium

External identifiers

EU CT number

2024-520097-36-00

ClinicalTrials.gov

NCT06920004

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Others, Safety, Pharmacodynamic, Efficacy

To demonstrate the efficacy of empasiprubart IV compared with IVIg in improving functional ability

Secondary objectives 15

1. 1. To demonstrate the efficacy of empasiprubart IV compared with IVIg on the participant’s activity and social limitations
2. 2. To demonstrate the efficacy of empasiprubart IV compared with IVIg on muscle strength and function
3. 3. To demonstrate the effect of empasiprubart IV compared with IVIg on the time to improvement
4. 4. To demonstrate the efficacy of empasiprubart IV compared with IVIg on gait impairment
5. 5. To assess the long-term efficacy of empasiprubart IV on gait impairment
6. 6. To assess the efficacy of empasiprubart IV compared with IVIg on the time to clinical deterioration
7. 7. To assess the efficacy of empasiprubart IV compared with IVIg and long-term efficacy of empasiprubart on muscle strength and function
8. 8. To assess the efficacy of empasiprubart IV compared with IVIg and long-term efficacy of empasiprubart Iv on functional ability
9. 9. To assess the long-term efficacy of empasiprubart IV on the participant’s activity and social limitations
10. 10. To assess the effect of empasiprubart IV compared with IVIg and long-term effect of empasiprubart IV on health-related quality of life and patient-reported outcome measures
11. 11. To assess the effect of empasiprubart IV on health-related productivity and work productivity
12. 12. To assess the immunogenicity of empasiprubart IV in participants with CIDP
13. 13. To assess the safety and tolerability of empasiprubart IV compared with IVIg and long-term safety and tolerability of empasiprubart IV in participants with CIDP
14. 14. To assess the PD effect of empasiprubart IV in participants with CIDP
15. 15. To assess the PK of empasiprubart IV in participants with CIDP

Conditions and MedDRA coding

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
2. 2. 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.
3. 3. Has responded to IVIg in the past 5 years.
4. 4. Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
5. 5. Has residual disability and active disease

Exclusion criteria 3

1. 1. Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
2. 2. 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
3. 3. Use of other long-acting immunomodulatory treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 19

1. 1. Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) centile points score at week 24
2. 2. Change from baseline in Medical Research Council Sum Score (MRC-SS) at week 24
3. 3. Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
4. 4. Time to reduction of ≥1 point from baseline in aINCAT score
5. 5. Change from baseline in Timed Up and Go (TUG) at week 24
6. 6. Time to increase of ≥1 point compared with baseline in aINCAT score by week 24
7. 7. 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
8. 8. Change from baseline in aINCAT over time
9. 9. Change from baseline in I-RODS centile points score over time
10. 10. Change from baseline in MRC-SS over time
11. 11. Change from baseline in TUG over time
12. 12. Change from baseline in EQ-5D-5L, RT-FSS, SF-12 and BPI-SF over time
13. 13. PGI-S and PGI-C values over time
14. 14. Values for work-related and household chore activities of the HRPQ
15. 15. Percentage of scheduled hours lost in total (absenteeism + presenteeism)
16. 16. Incidence and prevalence of antidrug antibodies and neutralizing antibodies against empasiprubart in serum
17. 17. Incidence and severity of adverse events, incidence of serious adverse events and clinically meaningful changes in laboratory parameters, ECG results, and vital signs
18. 18. Absolute values and percentage change from baseline in free C2 and total C2 over time
19. 19. Serum concentrations of empasiprubart over time

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Argenx

Sponsor organisation

Argenx

Address

Industriepark-Zwijnaarde 7

City

Gent

Postcode

9052

Country

Belgium

Scientific contact point

Organisation

Argenx

Contact name

Chief Scientific Officer

Public contact point

Organisation

Argenx

Contact name

Vice President Clinical Development

Third parties 14

Locations

19 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 213 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications