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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)

NCT04281472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2024-08-20

Study results available
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Summary

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

Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

BIOLOGICAL

efgartigimod PH20 SC in stage B

Stage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC

OTHER

placebo in stage B

Stage A: N/A, stage B: placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2023-05-11
Completion
2023-05-11
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • China
  • Czechia
  • Denmark
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281472 on ClinicalTrials.gov