Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency
Phase of Trial: Phase III
Latest Information Update: 05 Dec 2019
Price : $35 *
At a glance
- Drugs Tadekinig alfa (Primary)
- Indications Autoimmune disorders
- Focus Registrational; Therapeutic Use
- Sponsors AB2 Bio
- 21 Mar 2019 According to an AB2 Bio media release, the FDA has approved an IND under which this trial protocol has been amended in the U.S. to include a single-arm open label (SAOL) design with a randomized withdrawal phase for this trial. All the patients will be initially treated with Tadekinig alfa.
- 23 Jan 2019 Planned End Date changed from 1 Dec 2019 to 1 Jul 2020.
- 23 Jan 2019 Planned primary completion date changed from 1 May 2019 to 1 Nov 2019.