Efgartigimod PH20 SC for CIDP

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: argenx

Must be taking: IVIg

Disqualifiers: Autoimmune disease, other polyneuropathy, others

No Placebo Group

Prior Safety Data

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.

+2 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Efgartigimod PH20 SCExperimental Treatment1 Intervention

Participants start efgartigimod PH20 SC treatment after discontinuing IVIg