160 Participants NeededMy employer runs this trial

Empasiprubart for CIDP

(emnergize Trial)

Recruiting at 42 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12367

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.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial.

Up to 8 weeks

Treatment Part A

Participants receive either empasiprubart or a 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.

15 months

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials
76
Recruited
11,500+