Sjögren's disease & overlap diseases
A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjögren’s syndrome
Authors' conclusion
There was no clinically relevant improvement in ESSDAI score (primary endpoint), and no apparent benefit in favour of RO5459072 in any of the secondary clinical endpoints.
Study context
- Population
- Patients with pSSrandomised 1:1
- Participants
- 75 patients
- Comparison
- Cathepsin S inhibitor RO5459072 100 mg twice daily vs placebo for 12 weeks
- Primary endpoint
- Proportion of patients with a ≥3 point reduction from baseline in ESSDAI score
Methodological detailsdouble-blind, placebo-controlled, parallel-group, Phase IIA
- Double-blind
- Placebo-controlled
- Parallel-group
- Phase IIA
Primary result
As reported in the abstract
≥3 point reduction in ESSDAI
- Proportion with ESSDAI improvement not significantly different between RO5459072 and placebo
Secondary outcomes
Secondary outcomes (quality of life, exocrine gland function)
- No clinically meaningful treatment effects in favour of RO5459072 for all secondary outcomes
Soluble biomarkers
- Target engagement between RO5459072 and cathepsin S indicated
Circulating B cells and T cells
- Modest decreases with RO5459072, not significant
Original publication
A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjögren’s syndrome. Rheumatology (Oxford). Published 2 March 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →