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Trial record 1 of 1 for:    NCT05817669
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A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS) (rho)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05817669
Recruitment Status : Active, not recruiting
First Posted : April 18, 2023
Last Update Posted : February 8, 2024
Iqvia Pty Ltd
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Biological: Efgartigimod Biological: Placebo Phase 2

Detailed Description:
Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants will be randomized to receive efgartigimod 10 mg/kg or placebo in a 2:1 ratio, respectively. All participants will receive efgartigimod IV 10 mg/kg or placebo once weekly for 24 weeks during the treatment period
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
Actual Study Start Date : April 4, 2023
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Efgartigimod IV arm
patients receiving infusions of Efgartigimod IV
Biological: Efgartigimod
Patients receiving efgartigimod infusions

Placebo Comparator: Placebo arm
patients receiving infusions of placebo IV
Biological: Placebo
Patients receiving placebo infusions

Primary Outcome Measures :
  1. Proportion of CRESS responders on ≥3 of 5 items at week 24 [ Time Frame: up to week 24 ]
    The 5 items are Systemic disease activity: clinESSDAI; Patient-reported symptoms: ESSPRI; Tear gland function: Schirmer's test and OSS; Salivary gland function: UWSF rate and SGUS; Serology (serum IgG and/or RF)

Secondary Outcome Measures :
  1. Change in the relative counts of lymphocytic infiltrate (stained for CD45) at week24 [ Time Frame: up to 24 weeks ]
  2. Change in B/B+T cell ratio at week 24 [ Time Frame: up to 24 weeks ]
  3. Incidence and severity of TEAEs, AESIs, and SAEs by SOC and PT [ Time Frame: up to 35 weeks ]
    To evaluate the safety of efgartigimod IV compared to placebo in participants with pSS

  4. Clinically significant changes in vital sign measurements [ Time Frame: Up to 35 weeks ]
    weight in kg, Systolic Blood Pressure in mmHg, Diastolic Blood Pressure in mmHg, pulse in bpm

  5. Clinically significant changes in ECG results [ Time Frame: Up to 35 weeks ]
    Heart Rate in bpm, QRS in ms, PR in ms, QTc in ms

  6. Clinically significant changes in clinical laboratory safety evaluations [ Time Frame: Up to 35 weeks ]
    Chemistry, Haematology, HbA1C in %, Urinalysis, beta-hCG mUI/mL

  7. Proportion of participants with minimal clinically important improvement in ESSDAI: improvement of ≥3 points in ESSDAI score at week 24 [ Time Frame: up to 24 weeks ]
  8. Proportion of participants with low disease activity: ESSDAI score of <5 at week 24 [ Time Frame: up to 24 weeks ]
  9. Proportion of participants with minimal clinically important improvement in clinESSDAI: improvement of ≥3 points in clinESSDAI score at week 24 [ Time Frame: up to 24 weeks ]
  10. Proportion of participants with low disease activity: clinESSDAI score of <5 at week 24 [ Time Frame: up to 24 weeks ]
  11. Proportion of participants with minimal clinically important improvement in ESSPRI: decrease of 1 point or ≥15% at week 24 [ Time Frame: up to 24 weeks ]
  12. Change in ESSDAI score at week 24 [ Time Frame: up to 24 weeks ]
  13. Change in clinESSDAI score at week 24 [ Time Frame: up to 24 weeks ]
  14. Change in ESSPRI score at week 24 [ Time Frame: up to 24 weeks ]
  15. Proportion of participants with STAR score of ≥5 at week 24 [ Time Frame: up to 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is at least the legal age of consent for clinical trials when signing the informed consent form
  • Is capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
  • Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)

Exclusion Criteria:

  • Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
  • History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.
  • Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
  • Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of <200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of >200 cells/mm3 not adequately treated with antiviral therapy
  • Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
  • Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
  • Positive covid test at study start
  • Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study
  • Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP
  • Known hypersensitivity to IMP or 1 of its excipients
  • History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
  • Pregnant or lactating state or intention to become pregnant during the study
  • Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
  • Chinese traditional medicine with known immunomodulatory action

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05817669

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Sponsors and Collaborators
Iqvia Pty Ltd
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Responsible Party: argenx Identifier: NCT05817669    
Other Study ID Numbers: ARGX-113-2106
2021-005911-30 ( EudraCT Number )
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases