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A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy

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Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder in which there is inflammation of nerve roots and peripheral nerves and destruction of the fatty protective covering (myelin sheath) over the nerves. There is an unmet medical need for an efficacious treatment with a favorable safety and tolerability profile and more convenient administration than that provided by current treatments. A weekly subcutaneous (SC) treatment option consisting of efgartigimod PH20 SC administered within a few minutes could offer clinically significant benefits to CIDP patients. Stage A (open-label, efgartigimod PH20 SC; 4-12 weeks) Primary objective: to assess the activity of efgartigimod PH20 SC based on the percentage of patients classified as treatment responders. Stage B (double-blind, randomized-withdrawal, efgartigimod PH20 SC or placebo; up to 48 weeks) Primary objective: to determine the efficacy of efgartigimod PH20 SC compared to placebo based on the time needed for the occurrence of the first evidence of clinical deterioration.

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This study is NOT accepting healthy volunteers

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Rare Diseases

Clinics and Surgery Center (CSC)

Cathy Koukol - catk@umn.edu
Jeff Allen
Phase II
STUDY00008212
NCT04281472
See this study on ClinicalTrials.gov

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