RECRUITING

A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults with Systemic Sclerosis

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

The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.

Official Title

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants with Systemic Sclerosis

Quick Facts

Study Start:2024-11-11
Study Completion:2027-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06655155

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 aged ≥18 years and the local legal age of consent for clinical studies
  2. * Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
  3. * Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
  4. * Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
  5. * Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
  6. * The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
  7. * Has uninvolved or mildly thickened skin area in at least 1 injection site
  1. * Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
  2. * Significant Pulmonary Arterial Hypertension
  3. * Severe digital vasculopathy within the past 3 months
  4. * Skin thickening due to scleroderma mimics or localized scleroderma
  5. * Scleroderma renal crisis within the past 6 months of participating to the study
  6. * Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia

Contacts and Locations

Study Contact

Sabine Coppieters, MD
CONTACT
857-350-4834
clinicaltrials@argenx.com

Study Locations (Sites)

Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona, 85032-9306
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 Date2024-11-11
Study Completion Date2027-06-14

Study Record Updates

Study Start Date2024-11-11
Study Completion Date2027-06-14

Terms related to this study

Additional Relevant MeSH Terms

  • Systemic Sclerosis (SSc)