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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002101-21 | EudraCT Number |
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This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efgartigimod | Experimental | patients receiving efgartigimod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod | Biological | Intravenous infusion of efgartigimod |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of Adverse Events | Up to 60 weeks | |
| Frequency and severity of vital signs | Up to 60 weeks | |
| Frequency and severity of laboratory assessments | Up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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. |
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Inclusion criteria:
6. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
7. Patient has completed a 52-week treatment period.
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 0010045 | Washington D.C. | District of Columbia | 20007 | United States | ||
| Investigator Site 0010037 |
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| Over the 52 weeks of treatment |
| Mean change from baseline in platelet count at each visit. | Up to 60 weeks, at each visit |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Rate of receipt of rescue therapy (rescue per patient per month). | Up to 60 weeks, at each visit |
| Reduction in concurrent ITP therapy. | Up to 60 weeks, at each visit |
| Incidence and severity of the WHO-classified bleeding events. | Up to 60 weeks, at each visit |
| Change from baseline in Patient reported Outcomes (FACIT-Fatigue) at planned visits. | Up to 52 weeks |
| Change from baseline in Patient reported Outcomes (Fact-Th6) at planned visits. | Up to 52 weeks |
| Change from baseline in Quality of Life (SF-36) at planned visits. | Up to 52 weeks |
| Incidence of anti-drug antibodies (ADA) to efgartigimod. | Up to 216 weeks |
| Pharmacokinetic parameter of efgartigimod: serum concentration observed predose (Ctrough). | Up to 60 weeks |
| Pharmacodynamics markers: total IgG. | Up to 60 weeks |
| Ocala |
| Florida |
| 34474 |
| United States |
| Investigator Site 0010042 | Iowa City | Iowa | 52242 | United States |
| Investigator Site 0010040 | Columbus | Ohio | 43210 | United States |
| Investigator Site 0430002 | Vienna | Austria |
| Investigator Site 0430003 | Vienna | Austria |
| Investigator Site 0320012 | Brasschaat | Belgium |
| Investigator Site 0320011 | Bruges | Belgium |
| Investigator Site 0320014 | Turnhout | Belgium |
| Investigator Site 0320002 | Yvoir | Belgium |
| Investigator Site 3590001 | Pleven | Bulgaria |
| Investigator Site 3590002 | Sofia | Bulgaria |
| Investigator Site 4200001 | Brno | Czechia |
| Investigator Site 4200008 | Olomouc | Czechia |
| Investigator Site 4200006 | Ostrava | Czechia |
| Investigator Site 4200007 | Prague | Czechia |
| Investigator Site 0330009 | Créteil | France |
| Investigator Site 0330018 | Montpellier | France |
| Investigator Site 0330008 | Pessac | France |
| Investigator Site 0330016 | Périgueux | France |
| Investigator site 9950007 | Tbilisi | Georgia |
| Investigator site 9950008 | Tbilisi | Georgia |
| Investigator site 9950009 | Tbilisi | Georgia |
| Investigator site 9950011 | Tbilisi | Georgia |
| Investigator site 9950012 | Tbilisi | Georgia |
| Investigator Site 0490010 | Düsseldorf | Germany |
| Investigator Site 0490008 | Essen | Germany |
| Investigator Site 0360004 | Budapest | Hungary |
| Investigator Site 0360006 | Debrecen | Hungary |
| Investigator Site 0360015 | Győr | Hungary |
| Investigator Site 0360010 | Nyíregyháza | Hungary |
| Investigator Site 0360014 | Szombathely | Hungary |
| Investigator Site 0390014 | Milan | Italy |
| Investigator Site 0390020 | Monza | Italy |
| Investigator Site 0390015 | Novara | Italy |
| Investigator Site 0390010 | Ravenna | Italy |
| Investigator Site 0390011 | Reggio Calabria | Italy |
| Investigator Site 0390018 | Reggio Emilia | Italy |
| Investigator Site 0390019 | Rimini | Italy |
| Investigator Site 0390009 | Siena | Italy |
| Investigator Site 0390016 | Trieste | Italy |
| Investigator Site 0810015 | Hirakata | Japan |
| Investigator Site 0810010 | Hiroshima | Japan |
| Investigator Site 0810017 | Iruma | Japan |
| Investigator Site 0810022 | Kashiwa | Japan |
| Investigator Site 0810018 | Maebashi | Japan |
| Investigator Site 0810021 | Niigata | Japan |
| Investigator Site 0810014 | Sapporo | Japan |
| Investigator Site 0810016 | Shibukawa | Japan |
| Investigator Site 0810023 | Shimotsuke | Japan |
| Investigator Site 0310005 | Rotterdam | Netherlands |
| Investigator Site 0310006 | The Hague | Netherlands |
| Investigator Site 0480012 | Gdansk | Poland |
| Investigator Site 0480013 | Katowice | Poland |
| Investigator Site 0480011 | Lodz | Poland |
| Investigator Site 0480014 | Lublin | Poland |
| Investigator Site 0480026 | Nowy Sącz | Poland |
| Investigator Site 0070006 | Kaluga | Russia |
| Investigator Site 0070008 | Moscow | Russia |
| Investigator Site 0070007 | Petrozavodsk | Russia |
| Investigator Site 0070013 | Rostov-on-Don | Russia |
| Investigator Site 0070015 | Syktyvkar | Russia |
| Investigator Site 0070012 | Tula | Russia |
| Investigator Site 0070010 | Ufa | Russia |
| Investigator Site 0340006 | Barcelona | Spain |
| Investigator Site 0340007 | Barcelona | Spain |
| Investigator Site 0340009 | Madrid | Spain |
| Investigator Site 0340014 | Madrid | Spain |
| Investigator Site 0340012 | Palma de Mallorca | Spain |
| Investigator Site 0340015 | Pozuelo de Alarcón | Spain |
| Investigator Site 0340013 | Seville | Spain |
| Investigator Site 0340004 | Valencia | Spain |
| Investigator Site 0340011 | Valencia | Spain |
| Investigator Site 0900003 | Ankara | Turkey (Türkiye) |
| Investigator Site 0900006 | Ankara | Turkey (Türkiye) |
| Investigator Site 0900015 | Ankara | Turkey (Türkiye) |
| Investigator Site 0900016 | Edirne | Turkey (Türkiye) |
| Investigator Site 0900013 | Istanbul | Turkey (Türkiye) |
| Investigator Site 0900004 | Izmir | Turkey (Türkiye) |
| Investigator Site 0900010 | Mersin | Turkey (Türkiye) |
| Investigator Site 0900007 | Sakarya | Turkey (Türkiye) |
| Investigator Site 0900009 | Samsun | Turkey (Türkiye) |
| Investigator Site 0900017 | Tekirdağ | Turkey (Türkiye) |
| Investigator Site 0900019 | Trabzon | Turkey (Türkiye) |
| Investigator Site 3800006 | Mykolaiv | Ukraine |
| Investigator Site 0440008 | London | United Kingdom |
| Investigator Site 0440012 | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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