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
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Signed informed consent.
• Subjects must be 18 years or older at the time of signing the informed consent.
Locations
United States
California
First OC Dermatology Research Inc.
RECRUITING
Fountain Valley
Florida
Ziaderm Research LLC
RECRUITING
North Miami Beach
ForCare Clinical Research
RECRUITING
Tampa
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Kentucky
Kentucky Advanced Medical Research LLC
RECRUITING
Murray
Missouri
MediSearch LLC
RECRUITING
Saint Joseph
New York
Forest Hills Dermatology Group
RECRUITING
Kew Gardens
Ohio
Wright State Physicians
RECRUITING
Fairborn
Texas
Progressive Clinical Research, PA
RECRUITING
Texas City
Other Locations
Bulgaria
Medical Center Medconsult, Pleven OOD
RECRUITING
Lovech
Medical Center Medconsult pleven OOD
RECRUITING
Pleven
Medical Center Etika
RECRUITING
Plovdiv
ASMC IPSMC Skin and Venereal Diseases,
RECRUITING
Sofia
Medical Center Excelsior OOD,
RECRUITING
Sofia
Georgia
LTD Health
RECRUITING
Batumi
LLC Aversi Clinic
RECRUITING
Tbilisi
LLC Center of Allergy and Immunology
RECRUITING
Tbilisi
LTD Israel-Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
Germany
Institut Allergieforschung Charité - Universitatsmedizin Berlin
RECRUITING
Berlin
Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie
RECRUITING
Bochum
Universitatsklinikum Dresden Carl Gustav Carus
RECRUITING
Dresden
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
RECRUITING
Frankfurt
Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie
RECRUITING
München
Greece
General University Hospital Attikon
RECRUITING
Athens
General Hospital of Thessaloniki Papageorgiou
RECRUITING
Thessaloniki
Poland
Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.
RECRUITING
Gdansk
Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny
RECRUITING
Lodz
Labderm Essence sp.
RECRUITING
Ossy
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
RECRUITING
Wroclaw
Contact Information
Primary
Eva Wagner, PhD
clinicaltrials@inflarx.de; clinicaltrials@inflarx.com
+49 (0) 3641 508 180
Time Frame
Start Date: 2025-01-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 75
Treatments
Experimental: Arm 1 CSU
Lower dose of IFN904 BID
Experimental: Arm 2 CSU
Higher dose of IFN904 BID
Experimental: Arm 3 CSU
Non responders IgE, higher dose of IFN904 BID
Experimental: Arm 4 HS
Lower dose of IFN904 BID
Experimental: Arm 5 HD
Medium dose of IFN904 BID
Experimental: Arm 6 HD
High dose of IFN904 BID
Related Therapeutic Areas
Sponsors
Leads: InflaRx GmbH