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

Stopped early · Phase 2

Conditions studied: Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT06555328

Run by

InflaRx GmbH

People needed

73

Starts

2025-01-02

Expected to finish

2026-01-22

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Subjects must be 18 years or older at the time of signing the informed consent.

You may not qualify if…

• 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)

Where it is running

• First OC Dermatology Research Inc. — Fountain Valley, California, United States
• Ziaderm Research LLC — North Miami Beach, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Kentucky Advanced Medical Research LLC — Murray, Kentucky, United States
• MediSearch LLC — Saint Joseph, Missouri, United States
• Forest Hills Dermatology Group — Kew Gardens, New York, United States
• Wright State Physicians — Fairborn, Ohio, United States
• Progressive Clinical Research, PA — Texas City, Texas, United States
• Medical Center Medconsult, Pleven OOD — Lovech, Bulgaria
• Medical Center Medconsult pleven OOD — Pleven, Bulgaria
• Medical Center Etika — Plovdiv, Bulgaria
• ASMC IPSMC Skin and Venereal Diseases, — Sofia, Bulgaria
• Medical Center Excelsior OOD, — Sofia, Bulgaria
• LTD "Health" — Batumi, Georgia
• LTD "Israel-Georgian Medical Research Clinic Healthycore" — Tbilisi, Georgia
• LLC "Center of Allergy and Immunology" — Tbilisi, Georgia
• LLC "Aversi Clinic" — Tbilisi, Georgia
• "Institut Allergieforschung Charité - Universitatsmedizin Berlin" — Berlin, Germany
• Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie — Bochum, Germany
• Universitatsklinikum Dresden Carl Gustav Carus — Dresden, Germany
• Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie — Frankfurt, Germany
• "Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie" — München, Germany
• General University Hospital "Attikon" — Athens, Greece
• General Hospital of Thessaloniki "Papageorgiou" — Thessaloniki, Greece

Full record on ClinicalTrials.gov

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