A phase III, double-blind, randomized, placebo-controlled study of JBT-101 in diffuse cutaneous systemic sclerosis

Trial Profile

A phase III, double-blind, randomized, placebo-controlled study of JBT-101 in diffuse cutaneous systemic sclerosis

Planning
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Ajulemic acid (Primary)
  • Indications Systemic scleroderma
  • Focus Registrational; Therapeutic Use
  • Sponsors Corbus Pharmaceuticals
  • Most Recent Events

    • 09 Aug 2017 Planned number of patients changed from 270 to 350 according to a Corbus Pharmaceuticals media release.
    • 09 May 2017 According to a Corbus Pharmaceuticals media release, protocol assistance from the European Medicines Agency (EMA) on the Phase 3 study design is expected in the second quarter of 2017.
    • 09 May 2017 According to a company media release, Corbus expects to complete enrollment of the 52-week study in 2018. The Company also expects results by the end of 2019 and an NDA to be filed in 2020.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top