Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Change from baseline in mRSS at week 24	Up to 24 weeks	The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51.
Secondary	Change from baseline in mRSS at week 48	Up to 48 weeks	The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51.
Secondary	Incidence of treatment-emergent (serious) adverse events	Up to 55 weeks
Secondary	Proportion of participants who improve in at least 2 or at least 3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)	Up to 48 weeks	Revised Composite Response Index in Systemic Sclerosis (CRISS-25) is a global composite outcome assessment that provides a holistic perspective of the disease. It includes 5 core items: the Modified Rodnan Skin Score, the Clinician's global assessment, the Forced Vital Capacity, the Patient global assessment, and the Health Assessment Questionnaire-Disability Index.
Secondary	Change from baseline in HAQ-DI at weeks 24 and 48	Up to 48 weeks	Health Assessment Questionnaire-Disability Index is a tool to assess physical function and disability. It consists of 8 categories with each question scored from 0 (without any difficulty) to 3 (unable to do).
Secondary	Change from baseline in PGA at weeks 24 and 48	Up to 48 weeks	Patient's Global Assessment is a tool that measures a participant's global evaluation of their overall health during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
Secondary	Change from baseline in CGA at weeks 24 and 48	Up to 48 weeks	Clinician's Global Assessment is a tool that measures a clinician's assessment of the overall health of a participant during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
Secondary	Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease	Up to 48 weeks	Forced Vital Capacity is a tool to assess lung function
Secondary	Efgartigimod serum concentrations over time	Up to 48 weeks
Secondary	Percent change from baseline in total IgG levels in serum over time	Up to 55 weeks
Secondary	Incidence of anti-drug antibodies against efgartigimod in serum over time	Up to 55 weeks
Secondary	Incidence of antibodies against rHuPH20 in plasma over time	Up to 55 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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