Clinical trials: sponsored by 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
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.
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.
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
Generalized Myasthenia Gravis
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG.
- Trial name
- ADAPT+ (NCT03770403)
- Testing
- ARGX-113
- Where
- 52 sites in United States, Belgium and 13 more
- Volunteers
- 151 people
- Sponsor
- argenx
Generalized Myasthenia Gravis
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20…
- Trial name
- ADAPTsc (NCT04735432)
- Testing
- efgartigimod PH20 SC, efgartigimod IV
- Where
- 47 sites in United States, Belgium and 9 more
- Volunteers
- 110 people
- Sponsor
- argenx
Healthy Volunteers
SAD and MAD Study With IV and SC Doses of ARGX-117
This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117…
- Trial name
- ARGX-117 (NCT04532125)
- Testing
- ARGX-117, ARGX-117 + rHuPH20, ARGX-117 PH20 SC
- Where
- Netherlands
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- argenx
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for…
- Trial name
- NCT04264806
- Testing
- Azacitidine, Cusatuzumab
- Where
- 73 sites in Australia, Brazil and 9 more
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
- Trial name
- NCT05163834
- Testing
- Efgartigimod, PNEUMOVAX 23
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- argenx
Generalized Myasthenia Gravis
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.
- Trial name
- ADAPT (NCT03669588)
- Testing
- ARGX-113
- Where
- 66 sites in United States, Belgium and 14 more
- Volunteers
- 167 people
- Sponsor
- argenx
Healthy Volunteers
A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers
This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
- Trial name
- NCT04564066
- Testing
- efgartigimod IV, efgartigimod PH20 SC
- Where
- Netherlands
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus
The proposed study is an open-label, non-controlled, adaptive-design Phase II study to evaluate the safety, pharmacodynamics, pharmacokinetics, efficacy, and conditions of use (dosage, frequency of administration at maintenance)…
- Trial name
- NCT03334058
- Testing
- ARGX-113
- Where
- 12 sites in Germany, Hungary and 3 more
- Volunteers
- 34 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia (ITP)
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 patients with primary ITP.
- Trial name
- ADVANCE2 (NCT04274452)
- Testing
- efgartigimod
- Sponsor
- argenx
Bioavailability Study
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male…
- Trial name
- NCT03334084
- Testing
- ARGX-113
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of…
- Trial name
- NCT04073589
- Testing
- ARGX-113 with rHuPH20
- Where
- Netherlands
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- argenx
Cancer
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).
- Trial name
- NCT02759250
- Testing
- ARGX-110
- Where
- Belgium
- Volunteers
- 11 people
- Sponsor
- argenx
Cancer
A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.
- Trial name
- NCT02055066
- Testing
- ARGX-111
- Where
- 2 sites in Belgium
- Volunteers
- 24 people
- Sponsor
- argenx