Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:25 PM
Study NCT ID:
NCT06555328
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Sponsor:
InflaRx GmbH
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: