A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis
Phase of Trial: Phase II
Latest Information Update: 12 Feb 2019
At a glance
- Drugs Mavrilimumab (Primary) ; Prednisone
- Indications Giant cell arteritis
- Focus Proof of concept; Therapeutic Use
- Sponsors Kiniksa Pharmaceuticals
- 31 Jan 2019 Status changed from suspended to recruiting.
- 06 Dec 2018 According to a Kiniksa Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) requested additional information regarding the delivery device to be used in this study. In light of its device-related information request, the FDA has placed the company's recently-submitted IND on clinical hold.
- 06 Dec 2018 Status changed from recruiting to suspended, according to a Kiniksa Pharmaceuticals media release.