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

Primary Sjögren's Syndrome Clinical Trial

— Rho plus  

Official title:

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06203457
• Other study ID #: ARGX-113-2211
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 15, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: argenx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: August 15, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Biological:
• Efgartigimod
Patients receiving efgartigimod infusions

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent
Hungary	Vita Verum Medical Egeszsegugyi Szolgaltato Bt.	Szekesfehervar
Poland	Clinical Research Center Spólka z ograniczona odpowiedzialnoscia Medic-R Sp.k.	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
argenx	Iqvia Pty Ltd

Countries where clinical trial is conducted

Belgium,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with (serious) adverse events (of special interest)		up to week 48
Primary	Number of participants with with abnormal laboratory test results or vital signs		up to 48 weeks
Secondary	: 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.	up to 48 weeks
Secondary	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.	up to 48 weeks
Secondary	Proportion of participants with low disease activity: ESSDAI score of < 5 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.	up to 48 weeks
Secondary	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.	up to 48 weeks
Secondary	Proportion of participants with low disease activity: clinESSDAI score of < 5 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.	up to 48 weeks
Secondary	Proportion of participants with minimal clinically important improvement from baseline in ESSPRI: decrease of = 1 point or = 15% at weeks 24 and 48	ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSS. The total global score ranges from 0 to 10, with higher scores indicating more symptoms.	up to 48 weeks
Secondary	Change from baseline 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.	up to 48 weeks
Secondary	Change from baseline 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.	up to 48 weeks
Secondary	Change from baseline in ESSPRI score at weeks 24 and 48	ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSS. The total global score ranges from 0 to 10, with higher scores indicating more symptoms.	up to 48 weeks
Secondary	Proportion of STAR responders (score of = 5) at weeks 24 and 48 when compared to baseline	STAR (Sjögren's Tool for Assessing Response) has been developed to assess the efficacy of treatments for pSS.	up to 48 weeks
Secondary	Percent reduction from baseline in total IgG levels in serum over the 48-week treatment period		up to 48 weeks
Secondary	Percent reduction from baseline in autoantibodies (Anti-Ro/SS A and Anti-La/SS B) in serum over the 48-week treatment period		up to 48 weeks
Secondary	Efgartigimod serum concentrations over the 48-week treatment period		up to 48 weeks
Secondary	Incidence of ADA against efgartigimod over the 48-week treatment period		up to 48 weeks