A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Efgartigimod PH20 SC — BIOLOGICAL
  Subcutaneous administration of efgartigimod

Study Details

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Key Dates

Start date

Sep 18, 2020

Status verified

Jun 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

229 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: efgartigimod PH20 SC
  Patients treated with efgartigimod PH20 SC

Primary Outcome Measure

Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]

Locations (25)

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