A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Efficacy Of Pomalidomide (CC-4047) In Subjects With Systemic Sclerosis with Interstitial Lung Disease

Trial Profile

A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Efficacy Of Pomalidomide (CC-4047) In Subjects With Systemic Sclerosis with Interstitial Lung Disease

Discontinued
Phase of Trial: Phase II

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Pomalidomide (Primary)
  • Indications Interstitial lung diseases; Systemic scleroderma
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 01 Nov 2017 Owing to enrollment difficulty, the protocol was amended to increase the length of allowable disease duration (changed from 'onset of the first non-Raynaud SSc symptoms within 5 years prior to screening date' to 'onset of the first non-Raynaud symptoms to be within 7 years prior to screening'.)
    • 01 Nov 2017 Results published in The Journal of Rheumatology
    • 04 Mar 2017 This trial has been completed in Poland (end date: 3 Nov 2016).
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