NCT06555328

Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

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: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: InflaRx GmbH · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Conditions

• Chronic Urticaria, Idiopathic
• Hidradenitis
• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	CSU lower dose treatment	CSU lower dose treatment
DRUG	CSU high dose treatment	CSU high dose treatment
DRUG	CSU non responders IgE - high dose treatment	CSU non responders IgE - high dose treatment
DRUG	HS low dose treatment	HS low dose treatment
DRUG	HS medium dose treatment	HS medium dose treatment
DRUG	HS high dose treatment	HS high dose treatment

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-01-22
• Completion: 2026-01-22
• First posted: 2024-08-15
• Last updated: 2026-02-03

Locations

29 sites across 6 countries: United States, Bulgaria, Georgia, Germany, Greece, Poland

Regulatory

• FDA-regulated drug study