Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Phase 2CompletedNCT06203457

argenx24 enrolled

Overview

Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate the long-term safety of efgartigimod in participants with pSS who have completed the treatment period of the qualifying efgartigimod studies (including ARGX-113-2106).

ARGX-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pSS-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients with pSS. Participants will be enrolled from both active and placebo arms of qualifying efgartigimod studies and receive efgartigimod 10 mg/kg over 48 weeks in the extension study without knowledge of their treatment assignment in the qualifying study. Eligible participants must have completed the treatment period of the qualifying study and must not have permanently discontinued the IMP in that study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Sjögren's Syndrome

Interventions

EfgartigimodBIOLOGICAL

Patients receiving efgartigimod infusions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is at least the legal age of consent for clinical trials when signing the ICF * Is capable of providing signed informed consent and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP * Has completed the qualifying efgartigimod pSS studies and agrees to continue study drug treatment without interruption in the extension study Exclusion Criteria: * Clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) 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 * Pregnant or intention to become pregnant during the study * Any severe systemic pSS manifestation that may put the participant at undue risk based on the investigator's opinion

Locations (11)

Universitair Ziekenhuis Gent

Ghent, Belgium

Debreceni Egyetem

Debrecen, Hungary

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, Hungary

Outcomes

Primary Outcomes

Number of participants with (serious) adverse events (of special interest)

Time frame: up to week 48

Number of participants with with abnormal laboratory test results or vital signs

Time frame: up to 48 weeks

Secondary Outcomes

: Proportion of CRESS (Composite of Relevant Endpoints for Sjögren's Syndrome) responders on ≥ 3 of 5 items at weeks 24 and 48

The efficacy of efgartigimod is being assessed based on how the CRESS values change compared to the baseline visits.

Time frame: up to 48 weeks

Proportion of participants with minimal clinically important improvement from baseline in ESSDAI: improvement of ≥ 3 points in ESSDAI score at weeks 24 and 48

ESSDAI is a scoring system/scale - EULAR Sjögren's Syndrome disease activity index (0 to 123). The ESSDAI was designed to measure disease activity in patients with pSS. The lower the scores are, the lower the disease activity is.

Time frame: up to 48 weeks

Proportion of participants with low disease activity: ESSDAI score of < 5 at weeks 24 and 48

Time frame: up to 48 weeks

Proportion of participants with minimal clinically important improvement from baseline in clinESSDAI: improvement of ≥ 3 points in clinESSDAI score at weeks 24 and 48

ClinESSDAI derives from the ESSDAI, and its score provides an accurate evaluation of disease activity independent of B-cell biomarkers. The lower the scores are, the lower the disease activity is.

Data from ClinicalTrials.gov

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