Selection of currently ongoing clinical pharmaceutical trials at the NCRC

Multiple Sclerosis studies / MOGAD:

Title

 Link to the public  register

 Recruitment
status
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES)

 NCT04411641 active
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive  multiple sclerosis (PERSEUS)

 NCT04458051 active
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab as monotherapy or in addition to baseline therapy in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

 NCT05271409 active

A Randomized, double-blind, Placebo-controlled, multicenter Phase 3 pivotal study to evaluate the efficacy and safety of rozanolixizumab to treat adult patients with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

 NCT05063162 active

 

Myasthenia gravis studies:

Titel

 Link to the public register

 Recruitment
status
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized
Myasthenia Gravis 

 NCT03920293 active
Evaluating the Long-Term Safety and Tolerability of Efgartigimod
PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis (ADAPTSC+)

 NCT04818671 active
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis 

 NCT04951622 in preparation
A Phase 3B, Randomized, Open-label, Parallel-Group Trial to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (ADAPT NXT)

 NCT04980495 in preparation
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis

 NCT05218096 in preparation

 

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) studies:

Title

 Link to the public register 

 Recruitment
status
A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ADHERE)

 NCT04281472 active
Gamunex® 10% Use in Patients with Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP) or Multifocal Motor Neuropathy (MMN) in clinical Routine:
 Observational study to assess Individualized Treatment
Decisions (I-GUIDE)		 Sponsor-Reg.
GPN-001		 active

 

Autoimmune encephalitis studies:

Title

 Link to the public register

 Rekruitment
status
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis (AIE001)

NCT04875975 active