Efgartigimod PH20 SC for CIDP

Recruiting at 2 trial locations

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: argenx

Must be taking: IVIg

Disqualifiers: Autoimmune disease, other polyneuropathy, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 17-19 weeks

25 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Efgartigimod PH20 SC Experimental Treatment 1 Intervention

Participants start efgartigimod PH20 SC treatment after discontinuing IVIg

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