RECRUITING

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

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.

Conditions

Primary Sjogrens Disease
Talk to us

Related Conditions:

Primary Sjogrens Disease

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Primary Sjogrens Disease
Intervention / Treatment

-

Contacts and Locations

Clearwater

Clinical Research of West Florida, Inc., Clearwater, Florida, United States, 33765

Chicago

Chicago Clinical Research Institute, Chicago, Illinois, United States, 60607

Lake Charles

Accurate Clinical Research Inc., Lake Charles, Louisiana, United States, 70605

Baytown

Accurate Clinical Management, Baytown, Texas, United States, 77521

Houston

Accurate Clinical Research, Inc., Houston, Texas, United States, 77089

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
  • * 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)
  • * 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.
  • * 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.
  • * 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.
  • * Use of cyclophosphamide ≤ 24 weeks prior to screening
  • * Anti-CD20 or anti-CD19 antibody received \< 6 months before screening

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2028-07