Trial Profile
Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 18 Sep 2023
Price :
$35
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At a glance
- Drugs Vilobelimab (Primary)
- Indications Pyoderma gangrenosum
- Focus Adverse reactions; Proof of concept
- Acronyms OPTIMA
- Sponsors InflaRx
- 22 Mar 2023 According to an InflaRx media release, Based on compelling results and a productive End-of-Phase II meeting with the FDA in Q3 2022, company is moving forward with a pivotal Phase III clinical development program in this indication.
- 06 Jul 2022 According to an InflaRx media release, the US Food and Drug Administration (FDA) granted a Fast Track designation for for the treatment of ulcerative pyoderma gangrenosum (PG). The Company had submitted a request for Fast Track designation to the FDA based on data from this study.
- 12 May 2022 According to an InflaRx media release, end-of-Phase II meeting has been scheduled with the FDA for mid-2022 to discuss the pivotal program in this indication.