Empasiprubart for CIDP

(emnergize Trial)

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: argenx

Must not be taking: Long-acting immunomodulators

Disqualifiers: Possible CIDP, Sensory CIDP, Polyneuropathy, SLE, others

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

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of empasiprubart for adults with CIDP, a condition causing weakness and numbness in the arms and legs. In the first part, participants will receive either the new treatment (empasiprubart IV, an intravenous infusion) or a placebo for six months. Afterward, all participants will receive the actual treatment for two years. This trial suits individuals diagnosed with CIDP who experience ongoing symptoms and are willing to stop current CIDP treatments to try something new. As a Phase 3 trial, it 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?

Yes, if you are currently receiving treatment for CIDP, you will need to stop your current CIDP medications before starting the study medication.

Is there any evidence suggesting that empasiprubart is likely to be safe for humans?

Research has shown that empasiprubart has been tested in people with various health conditions. In one study, researchers compared it to another treatment for CIDP, a nerve disorder that causes weakness and numbness, to determine if empasiprubart could be an effective treatment option.

In another study involving patients with a different condition, empasiprubart was generally well-tolerated, with most participants not experiencing serious side effects. Some experienced mild to moderate side effects, but these were not severe enough to discontinue treatment.

The testing of empasiprubart in a late-stage trial indicates that earlier studies have deemed it safe enough for further evaluation. This usually suggests that the treatment is reasonably safe. However, participants should discuss potential risks and benefits with their healthcare providers before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for CIDP?

Researchers are excited about empasiprubart for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) because it offers a novel approach compared to current treatments like corticosteroids, immunoglobulins, and plasma exchange. Most existing treatments aim to suppress the immune system broadly or remove harmful antibodies, but empasiprubart targets specific immune pathways more precisely, potentially reducing side effects and improving outcomes. Additionally, empasiprubart is administered intravenously, which may ensure more consistent delivery and absorption in the body. This targeted and precise mechanism could lead to improved management of CIDP symptoms with fewer complications.

What evidence suggests that empasiprubart might be an effective treatment for CIDP?

Research has shown that empasiprubart blocks certain proteins, C3 and C5, which cause inflammation and tissue damage. This action may help reduce inflammation and damage in individuals with CIDP, a condition that leads to nerve damage. Although empasiprubart is not yet approved for treating CIDP, this trial will compare it to a placebo to evaluate its effectiveness in managing CIDP symptoms. Further research is needed to confirm its efficacy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who meet specific diagnostic criteria and have active disease with residual disability. Participants can be treatment-naive or may have stopped or are currently receiving certain treatments for CIDP.

Inclusion Criteria

I have been diagnosed with CIDP according to the latest guidelines.

I have CIDP or a type of CIDP like motor, multifocal, focal, or distal CIDP.

I have ongoing symptoms and my condition is currently active.

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 or placebo 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 IV
• Placebo IV

Trial Overview The trial is testing the effectiveness and safety of a drug called Empasiprubart in adults with CIDP. It's divided into two parts: Part A where participants get either Empasiprubart or a placebo for 6 months, followed by Part B where all participants receive Empasiprubart for an additional 24 months.

How Is the Trial Designed?

Group I: Part B - Empasiprubart Experimental Treatment 1 Intervention

Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.

Group II: Part A - Empasiprubart Experimental Treatment 1 Intervention

Participants receive empasiprubart during part A

Group III: Part A - Placebo Placebo Group 1 Intervention

Participants receive placebo during part A

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. 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 ...

4. trialstoday.org trialstoday.org/trial/NCT06920004

A Study to Assess Efficacy and Safety of Empasiprubart ... 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 ...

5. 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, ...

6. 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.

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

Trial Aims to Test Experimental CIDP Drug A new study testing the safety and efficacy of the experimental therapy empasiprubart in adults patients with CIDP is now open.