Clinical trials: sponsored by 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
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Study to Assess the Long-term 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 the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
- Trial name
- ADHERE+ (NCT04280718)
- Testing
- Efgartigimod PH20 SC
- Where
- 147 sites in United States, Austria and 22 more
- Volunteers
- 229 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
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
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