Vyvgart 1 000 mg solution for injection in pre-filled syringe
Sponsors
Argenx
Conditions
AChR-Ab Seropositive Generalized Myasthenia GravisGraves' Disease (GD)MGMyasthenia GravisOcular Myasthenia GravisPrimary Sjögren’s DiseaseSjogren’s Disease-Associated Sensorimotor Polyneuropathy (SMPN) or Sensory Polyneuropathy (SPN)Systemic Sclerosis
Phase 2
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
RecruitingCTIS2024-514539-67-00
Start: 2025-06-27Target: 119Updated: 2025-12-17
Master Protocol Full Title- 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.
ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
Not yet recruitingCTIS2025-522939-33-00
Target: 10Updated: 2026-07-10
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy
Not yet recruitingCTIS2026-526218-10-00
Target: 18Updated: 2026-09-09
Phase 3
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease
CompletedCTIS2023-509198-22-00
Start: 2024-10-21End: 2025-12-15Target: 48Updated: 2025-12-11
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis
Active, not recruitingCTIS2024-514133-38-00
Start: 2025-03-19Target: 169Updated: 2025-12-05
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
RecruitingCTIS2024-516609-22-00
Start: 2025-04-15Target: 248Updated: 2025-12-10
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
Not yet recruitingCTIS2025-523333-26-00
Target: 119Updated: 2026-08-11