Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

X
Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 05 Jun 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Risankizumab (Primary) ; Risankizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms INSPIRE
  • Sponsors AbbVie; AbbVie Germany
  • Most Recent Events

    • 31 May 2024 According to an AbbVie media release, the European Medicines Agencys (EMAs) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI) for the treatment of adults with moderately to severely active UC. The CHMP positive opinion is supported by data from two Phase 3 clinical trials: the INSPIRE induction trial and the COMMAND maintenance trial. The final European Commission decision is expected in the third quarter of 2024.
    • 22 Feb 2024 This trial has been completed in Portugal (Global end date: 11 May 2023) according to European Clinical Trials Database record.
    • 19 Feb 2024 According to AbbVie Media Release, data from the study will be presented at the 19th Congress of European Crohn's and Colitis Organisation (ECCO) taking place in Stockholm, Sweden from February 21-24.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top