Empasiprubart vs IVIg for CIDP

(emvigorate Trial)

Recruiting at 3 trial locations

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: argenx

Must be taking: IVIg

Must not be taking: Long-acting immunomodulatory

Disqualifiers: Autoimmune disease, Polyneuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, empasiprubart (a new potential drug) and IVIg (intravenous immunoglobulin), to determine which is more effective for people with CIDP, a condition causing muscle weakness and numbness. In Part A, participants will receive either empasiprubart or IVIg, each paired with a placebo resembling the other treatment, for 6 months. In Part B, all participants will receive empasiprubart for 24 months. The trial seeks participants who have struggled with CIDP, have previously tried IVIg, and continue to experience symptoms and disability. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be using other long-acting immunomodulatory treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that empasiprubart is generally safe for people. In previous studies, patients with various conditions used empasiprubart without major problems. This treatment blocks certain proteins in the body that cause inflammation and damage, reducing symptoms with few side effects.

IVIg is already FDA-approved for other uses and has been safely used by many patients. Some people might experience mild side effects like headaches or tiredness, but serious issues are rare.

Overall, both treatments have good safety records based on existing research and use. As with any treatment, monitoring for potential side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about empasiprubart for treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) because it offers a new approach compared to traditional treatments like IVIg and corticosteroids. Unlike these standard options, empasiprubart targets different pathways in the immune system, potentially leading to more effective management of CIDP symptoms. This novel mechanism of action could mean improved outcomes for patients who do not respond well to existing therapies. Additionally, empasiprubart might be associated with fewer side effects, making it a promising option for long-term management of the condition.

What evidence suggests that this trial's treatments could be effective for CIDP?

Research has shown that empasiprubart, one of the treatments in this trial, might help treat CIDP by reducing the need for repeated IVIg treatments and improving grip strength. Although still under study for CIDP, similar benefits appeared in people with another condition called MMN, suggesting potential effectiveness for CIDP as well. IVIg, the other treatment option in this trial, is already a proven treatment for CIDP, helping to lessen symptoms and slow the disease. By studying both treatments in separate arms, the researchers aim to determine if empasiprubart could be a better or additional option for people with CIDP. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have responded to IVIg treatment in the past 5 years. Participants should be on a stable IVIg dose and still show signs of active disease and disability. They must meet specific CIDP guidelines.

Inclusion Criteria

I have been diagnosed with CIDP according to specific guidelines.

I have CIDP or a specific type of CIDP.

I have had a positive response to IVIg treatment in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive either empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks

24 weeks

Treatment Part B

All participants receive empasiprubart for 96 weeks

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empasiprubart
• IVIg

Trial Overview The study compares empasiprubart against IVIg in treating CIDP over two parts: Part A has participants receiving either empasiprubart with an IVIg-placebo or actual IVIg with an empasiprubart-placebo for 6 months, followed by Part B where all get empasiprubart for 24 months.

How Is the Trial Designed?

Group I: Part B - empasiprubart Experimental Treatment 2 Interventions

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.

Group II: Part A - empasiprubart + IVIg-placebo Experimental Treatment 2 Interventions

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

Group III: Part A - IVIg + empasiprubart-placebo Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06920004

NCT06920004 | A Study to Assess Efficacy and Safety of ... 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 ...

2. clinicaltrials.argenx.com clinicaltrials.argenx.com/emvigorate

Emvigorate *The investigational study drug, empasiprubart, is not approved by any regulatory agency for the use in CIDP as efficacy and safety have not been established.

3. neurologylive.com neurologylive.com/view/phase-2-arda-findings-support-empasiprubart-multifocal-motor-neuropathy

Phase 2 ARDA Findings Support Development ... Phase 2 ARDA data showed empasiprubart reduced IVIg retreatment risk and improved grip strength in patients with MMN.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07091630

NCT07091630 | A Study to Assess the Efficacy and Safety ... The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where ...

5. rarediseaseadvisor.com rarediseaseadvisor.com/news/study-testing-experimental-cidp-drug-opens/

Trial Aims to Test Experimental CIDP Drug The primary outcome measure will be a reduction of at least 1 point from baseline in the Adjusted Inflammatory Neuropathy Cause and Treatment ...

6. argenx.com argenx.com/news/2025/press-release-3166778

argenx to Highlight Key Data and Breadth of Immunology ... By blocking complement activity upstream of C3 and C5, empasiprubart has the potential to reduce tissue inflammation and cellular damage, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725024550

POS1049 SAFETY, TOLERABILITY, AND EFFICACY OF ... This is a phase 2, randomized, double-blinded, placebo-controlled, multicenter study of IV administration of empasiprubart in adults with DM.