Innovation

Clinical Trials

Advancing Autoimmune Research Through Clinical Trials

We are pioneering innovation in autoimmune disease research through advanced immunology science and partnerships with patients, caregivers, and advocacy partners.   

Explore the studies below to learn more about each clinical trial, including eligibility criteria, study details, and participation opportunities. 

Shamrock

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Program: Efgartigimod

A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study, to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection

Polaris

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Program: Efgartigimod

A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult and Adolescent Participants With Autoimmune Encephalitis.

Emvigorate

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Program: Empasiprubart

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart  Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy.

Emnergize

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Program: Empasiprubart

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy.

CoMetS

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Program: Adimanebart

Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous Adimanebart in Adult and Pediatric Participants With DOK7-,MUSK-, AGRN-, or LRP4-CMS.

CMS Natural History Study

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Program: Adimanebart

Multicenter, Multinational, Natural History Study in Participants With Congenital Myasthenic Syndromes Due to Mutations in DOK7, MUSK, AGRN, or LRP4.

CMS Phase 1b – ARGX-119-2302

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Program: Adimanebart

A Phase 1b, Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Adult Participants with DOK7-Congenital Myasthenic Syndromes.

Varvara

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Program: Empasiprubart

Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function.

VitaliThy

vitalithy

Program: Efgartigimod

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs

Embridge

Guillain-Barré Syndrome (GBS)

Program: Empasiprubart

The embridge study aims to learn more about the safety of the investigational study drug and how it works with placebo when given together with intravenous immunoglobulin (IVIg) in adults with Guillain-Barré syndrome (GBS). IVIg is a standard care for GBS, and all participants will receive this treatment.

Advance Next

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Program: Efgartigimod

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants with Primary Immune Thrombocytopenia.

Advance Jr.

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Program: Efgartigimod

A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP

Verdant

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Program: ARGX-121

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy.

Empassion

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Program: Empasiprubart

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults with Multifocal Motor Neuropathy.

ARDA

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Program: Empasiprubart

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy.

iMMersioN

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Program: Empasiprubart

A Multicenter Prospective Longitudinal Study of Clinical Outcomes, Disease Course, Health-Related Quality of Life, and Health Care Resource Utilization in Adult Patients With Multifocal Motor Neuropathy.

EmpaSound

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Program: Empasiprubart

An Open-Label, Single-Arm, Phase 1b Study to Evaluate the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy.

Adapt Seron

 

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Program: Efgartigimod

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis.

Adapt Oculus

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Program: Efgartigimod

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants with Ocular Myasthenia Gravis.

Adapt Jr.

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Program: Efgartigimod

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis.

Adapt Jr. Sc

 

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Program: Efgartigimod

Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis.

Adapt Forward

 

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Program: Combination

A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis.

Navyvgate

 

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Program: Efgartigimod

Post-approval Non-Interventional Safety Study Observational, non-interventional, post-approval safety study (Ph4) in adult patients who have been diagnosed with generalized myasthenia gravis (gMG).

Post-approval Non-interventional Safety Study

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Program: Efgartigimod

A Worldwide Pregnancy Safety Study (Ph4) to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy And/Or Breastfeeding.

Alkivia

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Program: Efgartigimod

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy.

Unity

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Program: Efgartigimod

A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren's Disease.

Sparkle

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Program: Adimanebart

A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy (Sparkle).

eSScape

esscape

Program: Efgartigimod

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis.

Access to Investigational Medicines

Our approach is guided by patient need, physician recommendation, and responsible access to investigational therapies where no suitable treatment alternatives are available.

Pre-Approval Access

argenx supports Pre-Approval Access (PAA)  as a way to help eligible patients gain access to investigational medicines before regulatory approval, when appropriate and permitted by local regulations.

 

A licensed treating Physician may submit an unsolicited request for Pre-Approval Access  to an argenx medicine for a patient with a life-threatening or seriously debilitating illness, which cannot be treated satisfactorily with any currently authorized medicine.  argenx is committed to evaluating all requests in a fair and equitable manner and in accordance with all local laws and regulations.

Post-Trial Access

Post-Trial Access (PTA) refers to continued access to an investigational medicine for eligible participants after they complete a clinical trial, when continued treatment may be considered appropriate.

Explore More

At argenx, every piece of the innovation story connects. See where it leads next. 

Guide to Clinical 
Research

Information to understand clinical research and clinical trial participation.

Our Pipeline

Explore promising antibody research and treatments. 

Publications

Peer-reviewed publications that reflect our range of immunology innovation.

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