Clinical Trials Logo
  1. Home
  2. Generalized Myasthenia Gravis
  3. NCT04735432

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis — ADAPTsc  

Generalized Myasthenia Gravis Clinical Trial

Official title:
A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis

Clinical Trial Summary

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 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

Clinical Trial Description

Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for subcutaneous administration), administered once weekly for 4 administrations, is NI (noninferior) to IV infusions of efgartigimod (efgartigimod formulation for intravenous infusion) at a dose of 10 mg/kg administered once weekly for 4 administrations. Secondary objectives: To compare the PD effect of efgartigimod PH20 SC and efgartigimod IV over time; To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC and efgartigimod IV; To evaluate the safety, tolerability, and immunogenicity of efgartigimod PH20 SC and efgartigimod IV; To evaluate the clinical efficacy of efgartigimod PH20 SC and efgartigimod IV. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04735432
Study type Interventional
Source argenx
Contact
Status Completed
Phase Phase 3
Start date February 5, 2021
Completion date December 13, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05514873 - An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors Phase 3
Completed NCT04124965 - A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3
Recruiting NCT04833894 - Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Phase 2/Phase 3
Active, not recruiting NCT04963270 - A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis Phase 3
Active, not recruiting NCT02950155 - A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis Phase 3
Completed NCT03315130 - Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis Phase 2
Recruiting NCT05556096 - Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Phase 3
Not yet recruiting NCT06392386 - A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Phase 3
Not yet recruiting NCT06149559 - A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis Phase 2/Phase 3
Not yet recruiting NCT06193889 - A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT03920293 - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Phase 3
Completed NCT03770403 - A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. Phase 3
Not yet recruiting NCT06447597 - A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers. Phase 2/Phase 3
Completed NCT03971422 - A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3
Recruiting NCT05403541 - Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis Phase 3
Recruiting NCT05644561 - Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG) Phase 3
Not yet recruiting NCT06456580 - A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) Phase 3
Not yet recruiting NCT06463587 - Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Phase 3
Recruiting NCT06055959 - A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Phase 2/Phase 3
Completed NCT00515450 - Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis Phase 3