Status:
RECRUITING
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Lead Sponsor:
InflaRx GmbH
Conditions:
Chronic Urticaria, Idiopathic
Hidradenitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 wil...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Subjects must be 18 years or older at the time of signing the informed consent.
Exclusion
- Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
- Subjects who have any other skin disease that may interfere with assessment of CSU or HS.
- Subjects who have an active infection or history of infection(s) as follows:
- Any infection requiring systemic treatment within 14 days prior to baseline.
- A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
- Subjects with known progressed liver disease (Child-Pugh B or C)
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06555328
Start Date
January 2 2025
End Date
December 1 2025
Last Update
August 20 2025
Active Locations (29)
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1
First OC Dermatology Research Inc.
Fountain Valley, California, United States, 92708
2
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
3
ForCare Clinical Research
Tampa, Florida, United States, 33613
4
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250