A Study to Assess the 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 in stage B — BIOLOGICAL
  Stage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC
• placebo in stage B — OTHER
  Stage A: N/A, stage B: placebo

Study Details

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Key Dates

Start date

Apr 15, 2020

Status verified

Jul 2024

Primary completion

May 11, 2023

Completion

May 11, 2023

Study Design

Enrollment

322 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: efgartigimod PH20 SC
  patients receiving efgartigimod PH20 SC in both stage A as stage B
• Placebo Comparator: Placebo
  patients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B

Primary Outcome Measure

Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI) [ Time Frame: Up to 12 weeks during the open-label stage A ]

Locations (45)

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