RECRUITING

A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome

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 the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.

Official Title

A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren's Disease

Quick Facts

Study Start:2024-12-04
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06684847

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 for clinical studies when signing the ICF.
  2. * Meets the following criteria at screening: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)
  1. * Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis.
  2. * Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
  3. * Any severe systemic PSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion.
  4. * Use of cyclophosphamide ≤ 24 weeks prior to screening
  5. * Anti-CD20 or anti-CD19 antibody received \< 6 months before screening

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
United States
Chicago Clinical Research Institute
Chicago, Illinois, 60607
United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605
United States
Accurate Clinical Management
Baytown, Texas, 77521
United States
Accurate Clinical Research, Inc.
Houston, Texas, 77089
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 Date2024-12-04
Study Completion Date2028-07

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Sjogrens Disease