25 Participants Needed

Efgartigimod PH20 SC for CIDP

Recruiting at 2 trial locations
SC
Overseen BySabine Coppieters, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: argenx
Must be taking: IVIg
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, if you are on IVIg, oral corticosteroids, or nonsteroidal immunosuppressive medication, you need to be on a stable dose for a certain period before joining the trial.

Are You a Good Fit for This Trial?

Adults with CIDP who are currently on a stable IVIg treatment every 3-6 weeks can join this study. They must be at least 18 years old and meet specific diagnostic criteria for CIDP. Stable doses of immunosuppressives or low-dose oral corticosteroids are allowed, but there may be other factors that could exclude them.

Inclusion Criteria

I am at least 18 years old or the age of consent in my area.
I have been diagnosed with CIDP according to specific medical criteria.
I have been on a stable dose of nonsteroidal immunosuppressive medication for at least 3 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants transition from IVIg to efgartigimod PH20 SC treatment

17-19 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Efgartigimod PH20 SC
Trial Overview The trial is testing how well adults with CIDP adjust when switching from their regular IVIg treatments to a new medication called Efgartigimod PH20 SC. The study will last about 17 to 19 weeks per participant.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Efgartigimod PH20 SCExperimental Treatment1 Intervention

Find a Clinic Near You

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

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