ACTIVE_NOT_RECRUITING

A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.

Official Title

A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy Who Transition From Treatment With Intravenous Immunoglobulin to Efgartigimod PH20 SC

Quick Facts

Study Start:2024-12-10
Study Completion:2026-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06637072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is at least 18 years of age and the local legal age of consent
  2. * Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society
  3. * Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses
  4. * If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month.
  5. * If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months
  1. * Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk
  2. * Types of other polyneuropathy other than CIDP

Contacts and Locations

Study Locations (Sites)

MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Neurology Associates PA
Maitland, Florida, 32751
United States
Visionary Investigators Network
Miami, Florida, 33180
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Velocity Clinical Research
Lafayette, Louisiana, 70508
United States
SRI International - ClinEdge
Plymouth, Michigan, 48170
United States
Velocity Clinical Research
Raleigh, North Carolina, 27607
United States
Erlanger Neuroscience Institute
Chattanooga, Tennessee, 37403
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
National Neuromuscular Research Institute
Austin, Texas, 78759
United States
Horizon Clinical Research: Gill Neuroscience
Cypress, Texas, 21216
United States
Northwest Houston Neurology - Cypress
Cypress, Texas, 77429
United States
Cedar Health Research - Dallas
Dallas, Texas, 75251
United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2026-02-23

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2026-02-23

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Inflammatory Demyelinating Polyneuropathy