InflaRx initiates phase III clinical program with vilobelimab in hidradenitis suppurativa.
The new primary endpoint, called modified HiSCR (Hidradenitis Suppurativa Clinical Response), as suggested by the FDA, will include measuring the reduction of all three types of lesions – inflammatory nodules, abscesses and draining tunnels. InflaRx completed a Type A meeting with the FDA in September 2021 to align on the Phase III HS study design. The FDA response was supportive of a pivotal study program that focuses on patients with active draining tunnels and a new primary efficacy endpoint that includes measuring the reduction of all three lesions – inflammatory nodules, abscesses and draining tunnels.
InflaRx incorporated the FDA’s input and submitted the Phase III protocol to the Agency in late November 2021. The FDA had no comments during the 30-day review period; so, InflaRx will now begin the study, including bringing on clinical sites. Enrollment is slated to start in Q2 2022.
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