Registered outcomes20

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

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List	Outcome	Time frame
Primary	Frequency and severity of Adverse Events	Up to 60 weeks
Primary	Frequency and severity of vital signs	Up to 60 weeks
Primary	Frequency and severity of laboratory assessments	Up to 60 weeks
Secondary	Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10E9/L.	Over the 52 weeks of treatment
Secondary	Percentage of patients with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time during the 52-week treatment period.	Over the 52 weeks of treatment
Secondary	Mean change from baseline in platelet count at each visit.	Up to 60 weeks, at each visit
Secondary	For patients rolling-over from the ARGX-113-1801 trial with a platelet count of <30×10^9/L: time to response is defined as the time to achieve 2 consecutive platelet counts of ≥50×10^9/L	Up to 60 weeks, at each visit
Secondary	The percentage of weeks in the trial with platelet counts of ≥30×109/L and at least 20×10E9/L above baseline.	Over the 52 weeks of treatment
Secondary	In patients with baseline platelet count of <15×10E9/L in the current trial (ARGX-113-1803), the percentage of weeks in the trial with platelet counts of ≥30×10E9/L and at least 20×10E9/L above baseline.	Over the 52 weeks of treatment
Secondary	In patients with first exposure to efgartigimod: proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of at least 50×10^9/L for at least 4 of the 6 visits between week 19 and 24 of the trial.	Up to 5 weeks, between visit 19 and 24 of the trial
Secondary	In patients with first exposure to efgartigimod: proportion of patients in the overall population achieving platelet counts of at least 50x10^9/L for at least 6 of the 8 visits between week 17 and 24 of the trial.	Up to 7 weeks, between visit 17 and 24 of the trial
Secondary	Rate of receipt of rescue therapy (rescue per patient per month).	Up to 60 weeks, at each visit
Secondary	Reduction in concurrent ITP therapy.	Up to 60 weeks, at each visit
Secondary	Incidence and severity of the WHO-classified bleeding events.	Up to 60 weeks, at each visit
Secondary	Change from baseline in Patient reported Outcomes (FACIT-Fatigue) at planned visits.	Up to 52 weeks
Secondary	Change from baseline in Patient reported Outcomes (Fact-Th6) at planned visits.	Up to 52 weeks
Secondary	Change from baseline in Quality of Life (SF-36) at planned visits.	Up to 52 weeks
Secondary	Incidence of anti-drug antibodies (ADA) to efgartigimod.	Up to 216 weeks
Secondary	Pharmacokinetic parameter of efgartigimod: serum concentration observed predose (Ctrough).	Up to 60 weeks
Secondary	Pharmacodynamics markers: total IgG.	Up to 60 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.govNo license 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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