Patient Participation in Research
NOTICE TO HEALTHCARE PROFESSIONALS
A clinical trial in scleroderma is currently recruiting at the CHUM. (VITALISScE™ Trial)
Please read the details of this clinical trial (VITALISScE™) being conducted in the province of Quebec by Dr Sabrina Hoa’s team at the CHUM.
Clinical trial summary
The VITALISScETM clinical trial
A phase 2, randomized, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis (diffuse cutaneous system sclerosis (dcSSc) and limited cutaneous systemic sclerosis (lcSSc).
Investigational Treatment
The investigational medication, BI 685509, is being developed as a possible treatment for systemic sclerosis by targeting the disease’s underlying vasculopathy and fibrosis.
Study Objectives
The primary objective of the VITALISScE™ study is to demonstrate superiority of BI 685509 taken 3 times per day over placebo based on the mean difference in annual rate of decline in forced vital capacity over 48 weeks.
The key secondary objectives of the study are to demonstrate superiority of BI 685509 over placebo for absolute change from baseline in Modified Rodnan Skin Score at Week 48 in patients with dcSSc, proportion of responders in patients with dcSSc based on revised Composite Response Index in Systemic Sclerosis at Week 48, and for absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 48
Additional objectives are to evaluate safety, pharmacokinetic, and exploratory biomarkers.
Main eligibility criteria
Patients in the VITALISScE™ study must be 18 years of age or older (legal age at time of Informed Consent) and:
• Are patients with Sc, irrespective of associated ILD
• Must have PROGRESSING disease with FIBROSIS and VASCULOPATHY
Other criteria may apply.
To learn more or refer a potential VITALISScE™ study participant, please contact: uit.eligibilite.chum@ssss.gouv.qc.ca or 514-890-8000 ext. 30737