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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion 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)
Exclusion Criteria:
- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06684847
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	argenx
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Sjogrens Disease

Arms & Interventions

Arms

Experimental: Double-blinded treatment period: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC during the double-blinded treatment period

Placebo Comparator: Double-blinded treatment period: Placebo PH20 SC

Participants receiving placebo PH20 SC during the double-blinded treatment period

Experimental: Open-label treatment period

Participants receiving efgartigimod PH20 SC during the open-label treatment period

Interventions

Biological: - Efgartigimod PH20 SC

subcutaneous efgartigimod PH20 SC given by prefilled syringe

Other: - Placebo PH20 SC

subcutaneous placebo PH20 SC given by prefilled syringe

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research of West Florida, Inc., Clearwater, Florida

Status

Recruiting

Address

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765

Site Contact

Sydney Mullen

[email protected]

804-477-3045

Chicago Clinical Research Institute, Chicago, Illinois

Status