Efgartigimod PH20 SC for Chronic Inflammatory Demyelinating Polyneuropathy - Clinical Trial
What is the Purpose of this Study?
We are doing this study to see if an experimental drug called Efgartigimod PH20 SC is a safe and effective treatment for people with chronic inflammatory demyelinating polyneuropathy (CIDP).
The study drug is given as shots under your skin.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who Can Participate in the Study?
Adults 18 or older who:
- Are diagnosed with probable or definite CIDP (progressing or relapsing forms)
- Have not used any drugs to treat CIDP; OR
- Stopped taking IVIg, SCIg, or corticosteroids for 6 months before joining the study; OR
- Are willing to stop treatment with IVIg, SCIg, or corticosteroids to join the study
- Have not used immunosuppressant medication (e.g., Imuran or Cellcept) for 6 months before joining the study
What is Involved?
If you choose to join this study, you will:
- Participate in Stage A and Stage B (Stage A is first)
-- In Stage A, you will get the study drug for up to 13 weeks
-- In Stage B, you will get the study drug or a placebo (harmless, inactive shots) for up to 48 weeks
- Come to our clinic for shots and physical exams
- Give blood and urine samples
- Answer questionnaires
- Have the option to extend your time in the study when Stage B is finished