A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ADHERE)
Sponsor: |
Argenx BVBA |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS9502 |
U.S. Govt. ID: |
NCT04281472 |
Contact: |
Jorge Cabrera, CRC: 212-305-6035 / jec2273@cumc.columbia.edu |
The main goal of this study is to look at the effect and safety of efgartigimod PH20 SC in people with chronic inflammatory demyelinating polyneuropathy (CIDP). Another goal of the study is to collect information on how well efgartigimod works, how the body processes efgartigimod, what efgartigimod does to the body, and how your immune system reacts to efgartigimod. This trial will be conducted in 2 stages: An open-label Stage A and a randomized-withdrawal, double-blind, placebo-controlled Stage B. Approximately 360 patients aged 18 years and older male and non-pregnant female are planned to be enrolled in Stage A with a maximum of 180 randomized patients in Stage B.
This study is closed
Investigator
Thomas Brannagan, MD
Are you a male or female patient aged 18 years or older? |
Yes |
No |
Are you able to discontinue treatment with corticosteroids and/or IVIg or SCIg at least 6 months prior to screening? |
Yes |
No |
Are you currently pregnant or breastfeeding? |
Yes |
No |
Are you willing and able to comply with the trial protocol procedures? |
Yes |
No |
Have you been diagnosed with CIDP? |
Yes |
No |