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A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's Syndrome

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Jan 2022

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At a glance

  • Drugs Leniolisib (Primary)
  • Indications Sjogren's syndrome
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 09 Nov 2021 Results assessing possible options for alternative responder definitions that indicate the optimal balance of sensitivity and specificity from dour trials ((NCT02962895, NCT02775916; NCT02291029; NCT02149420) presented at the ACR Convergence 2021
    • 16 Jun 2018 Primary endpoint (EULAR Sjgrens Syndrome Patient Reported Intensity (ESSPRI) change from baseline) has not been met, according to results presented at the 19th Annual Congress of the European League Against Rheumatism.
    • 16 Jun 2018 Results presented at the 19th Annual Congress of the European League Against Rheumatism.
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