Clinical trials: sponsored by argenx
Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.
- Trial name
- POTS (NCT05918978)
- Testing
- Efgartigimod
- Where
- 9 sites in United States
- Volunteers
- 33 people
- Sponsor
- argenx
Bullous Pemphigoid
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity…
- Trial name
- BALLAD (NCT05267600)
- Testing
- efgartigimod PH20 SC, Prednisone
- Where
- 129 sites in United States, Australia and 19 more
- Volunteers
- 98 people
- Sponsor
- argenx
Healthy Volunteer
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers
This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06799416
- Testing
- ARGX-109
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- argenx
Primary Sjögren's Syndrome
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
- Trial name
- rho (NCT05817669)
- Testing
- Efgartigimod
- Where
- 17 sites in Belgium, Hungary and 2 more
- Volunteers
- 34 people
- Sponsor
- argenx
Postural Orthostatic Tachycardia Syndrome
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic…
- Trial name
- POTS (NCT05633407)
- Testing
- Efgartigimod
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who…
- Trial name
- ADDRESS+ (NCT04598477)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 127 sites in United States, Australia and 19 more
- Volunteers
- 183 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
- Trial name
- ADVANCE (NCT04188379)
- Testing
- efgartigimod
- Where
- 121 sites in United States, Austria and 16 more
- Volunteers
- 131 people
- Sponsor
- argenx
Membranous Nephropathy
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).
- Trial name
- NCT05810961
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 8 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
- Trial name
- ADVANCE SC (NCT04687072)
- Testing
- Efgartigimod PH20 SC
- Where
- 200 sites in United States, Argentina and 30 more
- Volunteers
- 207 people
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult…
- Trial name
- ADDRESS (NCT04598451)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 134 sites in United States, Australia and 19 more
- Volunteers
- 222 people
- Sponsor
- argenx
Myasthenia Gravis
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle…
- Trial name
- NCT02965573
- Testing
- ARGX-113
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 24 people
- Sponsor
- argenx
Healthy Volunteers
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy…
- Trial name
- NCT05670704
- Testing
- ARGX-119
- Where
- Netherlands
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
- Trial name
- ADHERE (NCT04281472)
- Testing
- efgartigimod PH20 SC in stage B
- Where
- 216 sites in United States, Austria and 23 more
- Volunteers
- 322 people
- Sponsor
- argenx
Renal Impairment
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
A study to test how kidney problems influence the blood concentrations of efgartigimod
- Trial name
- NCT05927415
- Testing
- Efgartigimod IV
- Where
- 2 sites in Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.
- Trial name
- NCT03457649
- Testing
- ARGX-113
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- argenx
Bioequivalence
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe…
- Trial name
- NCT05817435
- Testing
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- argenx
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, Inc.
Leukemia, Myeloid, Acute
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are…
- Trial name
- NCT04241549
- Testing
- Cusatuzumab, Azacitidine
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- OncoVerity, Inc.
Neoplasms
A Study of ARGX-110 in Participants With Advanced Malignancies
The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).
- Trial name
- NCT01813539
- Testing
- ARGX-110
- Where
- 8 sites in Belgium, France
- Volunteers
- 99 people
- Sponsor
- OncoVerity, Inc.
Primary Immune Thrombocytopenia
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.
- Trial name
- NCT03102593
- Testing
- ARGX-113
- Where
- 30 sites in Austria, Belgium and 8 more
- Volunteers
- 38 people
- Sponsor
- argenx