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.

For more information, please contact the study team at 919-681-3012 or vera.george@duke.edu. You can also get more information on the study's website: https://adherecidpstudy.com/

What is the Condition Being Studied?

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

Age Group
Adults

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

Study Details

Full Title
A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Principal Investigator
Protocol Number
IRB: PRO00105419
NCT: NCT04281472
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698