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Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

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Trial Profile

Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2025

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At a glance

  • Drugs INF 904 (Primary)
  • Indications Chronic urticaria; Hidradenitis suppurativa
  • Focus Adverse reactions
  • Sponsors InflaRx

Most Recent Events

  • 07 Aug 2025 According to an InflaRx media release, data from this last cohort in CSU will be announced in due course and, given sufficient demonstrated potential in the all-comer arms, is not expected to impact the timing of CSU Phase 2b trial initiation.
  • 07 Aug 2025 According to an InflaRx media release, the data will include all three HS dosing cohorts (60 mg, 90 mg, and 120 mg BID), as well as the two main CSU dosing cohorts (patients dosed with either 60 mg or 120 mg BID), which include both anti-IgE naive and anti-IgE experienced patients. Enrollment is ongoing for a third CSU dosing cohort (120 mg) targeting the Type IIb phenotype, with patients stringently selected for being highly refractory to anti-IgE therapy.
  • 07 Aug 2025 According to InflaRx media release, phase 2a data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected by the end of September to early November 2025.

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