A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period

Conditions

Systemic sclerosis

Brief summary

Change from baseline (BL) in modified Rodnan Skin Score at week 52

Detailed description

Change from BL in forced vital capacity at week 52, Proportion of responders to the treatment based on the revised Composite Response Index in Systemic Sclerosis at week 52, Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs (SAEs), treatment-emergent AEs of special interest (AESIs), significant SSc-related TEAEs, TEAEs leading to IP discontinuation, and TEAEs leading to study discontinuation., Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal ECG findings; Incidence of abnormal weight change throughout the 52-week main treatment period, Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal weight change the throughout 156-week extension treatment period, Nemolizumab serum concentrations. Detection and characterization of anti-drug antibodies

Related papers

No related papers found yet.

Interventions

DRUGNemluvio 30 mg powder and solvent for solution for injection in pre-filled pen

DRUGPlacebo Lyophilized Powder for Solution for Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline (BL) in modified Rodnan Skin Score at week 52	—

Secondary

Measure	Time frame
Change from BL in forced vital capacity at week 52, Proportion of responders to the treatment based on the revised Composite Response Index in Systemic Sclerosis at week 52, Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs (SAEs), treatment-emergent AEs of special interest (AESIs), significant SSc-related TEAEs, TEAEs leading to IP discontinuation, and TEAEs leading to study discontinuation., Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal ECG findings; Incidence of abnormal weight change throughout the 52-week main treatment period, Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal weight change the throughout 156-week extension treatment period, Nemolizumab serum concentrations. Detection and characterization of anti-drug antibodies	—

Measure

Time frame

Change from BL in forced vital capacity at week 52, Proportion of responders to the treatment based on the revised Composite Response Index in Systemic Sclerosis at week 52, Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs (SAEs), treatment-emergent AEs of special interest (AESIs), significant SSc-related TEAEs, TEAEs leading to IP discontinuation, and TEAEs leading to study discontinuation., Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal ECG findings; Incidence of abnormal weight change throughout the 52-week main treatment period, Incidence of abnormal vital signs; Incidence of abnormal laboratory parameters; Incidence of abnormal weight change the throughout 156-week extension treatment period, Nemolizumab serum concentrations. Detection and characterization of anti-drug antibodies

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Outcome results

None listed