A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease

Conditions

Sjögren’s Disease

Brief summary

Change from baseline in European League Against Rheumatism (EULAR) Sjögren’s Disease Activity Index (ESSDAI) at Week 24 (Change from baseline of individual ESSDAI domains will also be reported as supportive information.)

Detailed description

Proportion of Sjögren’s Tool for Assessing Response (STAR) responders (≥ 5 points) at Week 24 and evaluation of the individual STAR domains, Change from baseline in ESSDAI over time, Proportion of STAR responders (≥ 5 points) over time, Change from baseline in Stimulated Salivary Flow at Week 24 and over time, Change from baseline in Unstimulated Salivary Flow at Week 24 and over time, Change from baseline in ESSPRI at Week 24 and over time, Change from baseline in Schirmer’s test at Week 24 and over time, Change from baseline in clinESSDAI at Week 24 and over time, Change from baseline in FACIT-Fatigue at Week 24 and over time, Change from baseline in EQ-5D 5L at Week 24 and over time, Incidence of treatment-emergent adverse events (TEAEs), and serious AEs (SAEs), Clinically significant laboratory or electrocardiogram (ECG) changes, Abiprubart serum concentrations over time, and PK parameters, Antidrug antibodies, Receptor occupancy (RO, US clinical sites only)

Related papers

No related papers found yet.

Interventions

DRUGA sterile preservative-free solution with identical composition as the drug product

DRUGbut without the protein.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in European League Against Rheumatism (EULAR) Sjögren’s Disease Activity Index (ESSDAI) at Week 24 (Change from baseline of individual ESSDAI domains will also be reported as supportive information.)	—

Secondary

Measure	Time frame
Proportion of Sjögren’s Tool for Assessing Response (STAR) responders (≥ 5 points) at Week 24 and evaluation of the individual STAR domains, Change from baseline in ESSDAI over time, Proportion of STAR responders (≥ 5 points) over time, Change from baseline in Stimulated Salivary Flow at Week 24 and over time, Change from baseline in Unstimulated Salivary Flow at Week 24 and over time, Change from baseline in ESSPRI at Week 24 and over time, Change from baseline in Schirmer’s test at Week 24 and over time, Change from baseline in clinESSDAI at Week 24 and over time, Change from baseline in FACIT-Fatigue at Week 24 and over time, Change from baseline in EQ-5D 5L at Week 24 and over time, Incidence of treatment-emergent adverse events (TEAEs), and serious AEs (SAEs), Clinically significant laboratory or electrocardiogram (ECG) changes, Abiprubart serum concentrations over time, and PK parameters, Antidrug antibodies, Receptor occupancy (RO, US clinical sites only)	—

Measure

Time frame

Proportion of Sjögren’s Tool for Assessing Response (STAR) responders (≥ 5 points) at Week 24 and evaluation of the individual STAR domains, Change from baseline in ESSDAI over time, Proportion of STAR responders (≥ 5 points) over time, Change from baseline in Stimulated Salivary Flow at Week 24 and over time, Change from baseline in Unstimulated Salivary Flow at Week 24 and over time, Change from baseline in ESSPRI at Week 24 and over time, Change from baseline in Schirmer’s test at Week 24 and over time, Change from baseline in clinESSDAI at Week 24 and over time, Change from baseline in FACIT-Fatigue at Week 24 and over time, Change from baseline in EQ-5D 5L at Week 24 and over time, Incidence of treatment-emergent adverse events (TEAEs), and serious AEs (SAEs), Clinically significant laboratory or electrocardiogram (ECG) changes, Abiprubart serum concentrations over time, and PK parameters, Antidrug antibodies, Receptor occupancy (RO, US clinical sites only)

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Countries

Czechia, France, Germany, Hungary, Poland, Spain

Outcome results

None listed