Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Megadott ok: Sponsor Decision
A legfontosabb adatok
- Hol
- Fairborn, Fountain Valley, Indianapolis, Kew Gardens, Murray, North Miami Beach, Saint Joseph, Tampa és Texas City (Egyesült Államok)Mind a 9 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Wright State PhysiciansFairborn, Egyesült ÁllamokNo longer taking part
- First Oc Dermatology Research IncFountain Valley, Egyesült ÁllamokNo longer taking part
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, Egyesült ÁllamokNo longer taking part
- Forest Hills Dermatology GroupKew Gardens, Egyesült ÁllamokNo longer taking part
- Kentucky Advanced Medical Research LLCMurray, Egyesült ÁllamokNo longer taking part
- Ziaderm Research LLCNorth Miami Beach, Egyesült ÁllamokNo longer taking part
- Medisearch, LLCSaint Joseph, Egyesült ÁllamokNo longer taking part
- ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Progressive Clinical Research, PATexas City, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- InflaRx GmbH
- Azonosító
- NCT06555328EU 2024-515615-22-00
- A regiszteradat frissítve
- 2026. február 3.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: Signed informed consent; Subjects must be 18 years or older at the time of signing the informed consent.
Kizáró feltételek: 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 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 with known progressed liver disease (Child-Pugh B or C).