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Presentation
of the trial
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis

To learn more about this study, you may contact the study research staff:
Mari Carmen DELATTE
mari-carmen.delatte@inventivapharma.com

Outcomes

Primary and secondary endpoints:

  • Primary endpoint
    • The mean change of the mRSS from baseline to 48 weeks
  • Secondary endpoints
    • mRSS response rates; improvers are defined by a reduction ≥ 5 points and ≥ 25 % of mRSS
    • Overall progression of the disease: defined as absence of rescue therapy and absence of severe organ involvement
    • Change in pulmonary function tests (FVC% predicted and cDLCO% predicted)
    • Changes in patient reported outcomes (SHAQ, UCLA SCTC GIT, PROMIS29, SF36)
    • Digital ulcer net burden (defined as total number of ulcers at a certain time point minus number of ulcers at baseline) and proportion of patients who do not develop new ulcers
    • Cochin Hand Function Scale
    • Physician and patient global assessments of disease activity (VAS)
    • Change in the Combined Response Index for Systemic Sclerosis (CRISS), consisting of five variables: mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI score (from SHAQ patient reported outcome)
    • Need for escape therapy (% patients)
    • Severe organ involvement (% patients) defined by Prof Denton in the next presentation.
    • Frequency and type of AEs
    • Lab tests: mean change and frequency of values outside the normal range
    • Raynaud phenomenon (Raynaud’s condition score)
    • Mean changes in activity biomarkers
    • Follow-up visit to evaluate any changes that might occur within 12 weeks after completion of the treatment.

Schedule of procedures:

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