Empasiprubart for Dermatomyositis

(empacific Trial)

Not currently recruiting at 33 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Disqualifiers: Autoimmune disease, Malignancy, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 25 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of a new treatment, empasiprubart, for individuals with dermatomyositis, a condition that causes muscle weakness and skin rashes. Participants will receive either empasiprubart or a placebo (a harmless pill with no active drug) to compare results. Ideal candidates are adults with a confirmed diagnosis of dermatomyositis who have active muscle and mild skin issues. Participants must have tried standard treatments for dermatomyositis and meet certain health requirements. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must comply with the permitted background dermatomyositis treatment requirements at screening.

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

Research shows that empasiprubart is being tested for safety in treating dermatomyositis, a condition causing muscle weakness and skin rash. Earlier studies suggest that empasiprubart blocks certain actions in the body that lead to tissue inflammation, potentially reducing symptoms in patients.

Although specific side effects from these studies aren't detailed, empasiprubart's progression to a phase 2 trial indicates some level of safety in earlier research. Phase 2 trials typically involve more participants to further assess safety and tolerability. If empasiprubart wasn't considered safe enough, it wouldn't have advanced to this stage.

In summary, empasiprubart has shown promise in early studies for safety, but ongoing research is essential to fully understand its effects on people with dermatomyositis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Empasiprubart for dermatomyositis because it offers a fresh approach compared to current treatments like corticosteroids and immunosuppressants. Unlike these traditional therapies, which primarily dampen the immune system, Empasiprubart targets specific inflammatory pathways, potentially reducing muscle inflammation more effectively and with fewer side effects. This targeted action could lead to better patient outcomes and improved quality of life for those dealing with this challenging condition.

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

Research has shown that empasiprubart, which participants in this trial may receive, might help reduce inflammation in dermatomyositis (DM) by blocking certain immune system activities. Early results suggest that targeting this part of the immune system could decrease tissue inflammation. Although limited data exists on its effectiveness in people, the treatment's mechanism appears promising for improving DM symptoms. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults with dermatomyositis who can consent, are at least 18 years old, agree to use contraception, and have active muscle disease. They must meet specific lab test criteria or show signs of inflammation on an MRI or biopsy. Participants should be vaccinated against certain infections before starting the trial.

Inclusion Criteria

I can sign the consent form and follow the study rules.

I agree to use birth control and have negative pregnancy tests before starting the trial.

I follow the treatment plan for my skin and muscle inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either empasiprubart or placebo for 25 weeks

25 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

65 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empasiprubart

Trial Overview The study tests Empasiprubart IV against a placebo in adults with dermatomyositis over approximately 92 weeks. Participants will be randomly assigned in a 2:1 ratio to receive either the drug or placebo for 25 weeks followed by a safety follow-up period of 65 weeks.

How Is the Trial Designed?

Group I: Empasiprubart Experimental Treatment 1 Intervention

Patients receiving Empasiprubart IV

Group II: Placebo Placebo Group 1 Intervention

Patients receiving Placebo IV

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/NCT06284954

NCT06284954 | A Study to Evaluate Safety and Efficacy of ... This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-empasiprubarts-effect-on-the-body-levels-in-the-blood-effectiveness-and-safety-in-adu

A Study to Evaluate Safety and Efficacy of Empasiprubart in ... This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).

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

POS1049 SAFETY, TOLERABILITY, AND EFFICACY OF ... EMPACIFIC (NCT06284954) is a phase 2 trial that evaluates the safety, tolerability, and efficacy of empasiprubart compared with placebo in adults with DM.

4. argenxmedical.com argenxmedical.com/content/dam/medical-affairs/congress-posters/nuerology/eular-june-2025/Safety_%20Tolerability_%20and%20Efficacy%20of%20Empasiprubart%20in%20Adults%20With%20Dermatomyositis%20(EMPACIFIC)%20A%20Phase%202_%20Randomized_%20Double-Blinded_%20Placebo-Controlled_%20Multicenter%20Study.pdf

POS1049 *Measured at weeks 13 and 25. By blocking upstream complement activity, empasiprubart may reduce tissue inflammation in patients with DM.

5. argenx.com argenx.com/news/2024/argenx-presents-new-efgartigimod-data-at-eular-2025-highlighting

argenx Presents New Efgartigimod Data at EULAR 2025 ... In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60) ...

6. argenx.com argenx.com/news/2025/press-release-3097206

argenx Presents New Efgartigimod Data at EULAR 2025 ... In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60) ...