Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06203457
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06203457
Study Brief:
Protocol Section:
NCT06203457