Systemic sclerosis & Raynaud's
A 24‐Week, Phase IIa, Randomized, Double‐Blind, Placebo‐Controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis
Authors' conclusion
Ziritaxestat resulted in significantly greater reduction in MRSS at week 24 than placebo; no new safety signals emerged.
Study context
- Population
- Adults with early diffuse cutaneous systemic sclerosis (dcSSc)
- Participants
- 21 vs 12
- Comparison
- Oral ziritaxestat 600 mg once daily vs matching placebo
- Ziritaxestatn = 21
- Placebon = 12reference
- Primary endpoint
- Change from baseline in mRSS
- Follow-up
- Week 24
Methodological detailsphase IIa, double-blind, placebo-controlled, multicentre, 24-week, 104-week open-label extension
- Phase IIa
- Double-blind
- Placebo-controlled
- Multicentre
- 24-week
- 104-week open-label extension
Primary result
As reported in the abstract
Ziritaxestat
−8.9
units
Placebo
−6.0
units
P = 0.0411
Secondary outcomes
mRSS in placebo patients switching to ziritaxestat in the open-label extension (OLE)
- Similar reductions in mRSS to those observed for ziritaxestat patients in the parent study
Circulating lysophosphatidic acid (LPA) C18:2
- Significantly reduced, demonstrating target engagement
Blood fibrosis biomarkers
- Levels reduced in the blood
Gene expression
- Significant changes in genes in blood samples
- 109
- No differentially expressed genes in skin biopsies
Safety
Tolerability and treatment-related TEAEs
- Ziritaxestat well tolerated; most frequent treatment-related TEAEs were headache and diarrhoea
Original publication
A 24‐Week, Phase IIa, Randomized, Double‐Blind, Placebo‐Controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. Published 15 May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →