A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients with Generalized Myasthenia Gravis (EMERGE)

Conditions

generalized Myasthenia gravis

Brief summary

Change from Baseline to Week 17 in MG-ADL scale score

Detailed description

• Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) scale score • Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) scale score • Proportion of participants with a ≥ 5-point reduction in MG-ADL scale score at Week 17 compared to Baseline, • Proportion of participants who reach minimal symptom expression (MSE), defined as MG-ADL 0 or 1 at Week 17, without use of rescue therapy • Proportion of participants with a ≥ 5-point reduction in QMG scale score at Week 17 compared to Baseline, Incidence of TEAEs and treatment-emergent SAEs in the RCT period, BEP, OLE, and Safety Follow-Up, Serum concentrations of claseprubart, PD parameters in serum ex vivo, Incidence and titer of ADA against claseprubart in the RCT period, BEP, OLE, and the Safety Follow-up

Related papers

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Interventions

DRUGDNTH103

DRUGPlacebo for DNTH103 solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 17 in MG-ADL scale score	—

Secondary

Measure	Time frame
• Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) scale score • Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) scale score • Proportion of participants with a ≥ 5-point reduction in MG-ADL scale score at Week 17 compared to Baseline, • Proportion of participants who reach minimal symptom expression (MSE), defined as MG-ADL 0 or 1 at Week 17, without use of rescue therapy • Proportion of participants with a ≥ 5-point reduction in QMG scale score at Week 17 compared to Baseline, Incidence of TEAEs and treatment-emergent SAEs in the RCT period, BEP, OLE, and Safety Follow-Up, Serum concentrations of claseprubart, PD parameters in serum ex vivo, Incidence and titer of ADA against claseprubart in the RCT period, BEP, OLE, and the Safety Follow-up	—

Measure

Time frame

• Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) scale score • Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) scale score • Proportion of participants with a ≥ 5-point reduction in MG-ADL scale score at Week 17 compared to Baseline, • Proportion of participants who reach minimal symptom expression (MSE), defined as MG-ADL 0 or 1 at Week 17, without use of rescue therapy • Proportion of participants with a ≥ 5-point reduction in QMG scale score at Week 17 compared to Baseline, Incidence of TEAEs and treatment-emergent SAEs in the RCT period, BEP, OLE, and Safety Follow-Up, Serum concentrations of claseprubart, PD parameters in serum ex vivo, Incidence and titer of ADA against claseprubart in the RCT period, BEP, OLE, and the Safety Follow-up

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Outcome results

None listed