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

Last updated: January 30, 2026
Sponsor: InflaRx GmbH
Overall Status: Terminated

Phase

2

Condition

Urticaria

Hives (Urticaria)

Scalp Disorders

Treatment

CSU high dose treatment

CSU lower dose treatment

HS low dose treatment

Clinical Study ID

NCT06555328
INF904- P2.1
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent.

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

Exclusion

Exclusion Criteria:

  • Subjects with known severe or life-threatening hypersensitivity reaction to anyother CSU/HS treatment according to National Cancer Institute-Common TerminologyCriteria for Adverse Events (NCI-CTCAE).

  • Subjects who have any other skin disease that may interfere with assessment of CSUor HS.

  • Subjects who have an active infection or history of infection(s) as follows:

  1. Any infection requiring systemic treatment within 14 days prior to baseline.

  2. A history of opportunistic, recurrent, or chronic infections that, in theopinion of the Investigator, might cause this study to be detrimental to thesubject.

  • Subjects with known progressed liver disease (Child-Pugh B or C)

Study Design

Total Participants: 73
Treatment Group(s): 6
Primary Treatment: CSU high dose treatment
Phase: 2
Study Start date:
January 02, 2025
Estimated Completion Date:
January 22, 2026

Connect with a study center

  • Medical Center Medconsult, Pleven OOD

    Lovech, 5500
    Bulgaria

    Site Not Available

  • Medical Center Medconsult, Pleven OOD

    Lovech 729559, 5500
    Bulgaria

    Site Not Available

  • Medical Center Medconsult pleven OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Medical Center Medconsult pleven OOD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • Medical Center Etika

    Plovdiv, 4200
    Bulgaria

    Site Not Available

  • Medical Center Etika

    Plovdiv 728193, 4200
    Bulgaria

    Site Not Available

  • ASMC IPSMC Skin and Venereal Diseases,

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD,

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • ASMC IPSMC Skin and Venereal Diseases,

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD,

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • LTD "Health"

    Batumi, 6010
    Georgia

    Site Not Available

  • LTD "Health"

    Batumi 615532, 6010
    Georgia

    Site Not Available

  • LLC "Aversi Clinic"

    Tbilisi, 0160
    Georgia

    Site Not Available

  • LLC "Center of Allergy and Immunology"

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • LLC "Aversi Clinic"

    Tbilisi 611717, 0160
    Georgia

    Site Not Available

  • LLC "Center of Allergy and Immunology"

    Tbilisi 611717, 0159
    Georgia

    Site Not Available

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi 611717, 0112
    Georgia

    Site Not Available

  • "Institut Allergieforschung Charité - Universitatsmedizin Berlin"

    Berlin, 12203
    Germany

    Site Not Available

  • "Institut Allergieforschung Charité - Universitatsmedizin Berlin"

    Berlin 2950159, 12203
    Germany

    Site Not Available

  • Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie

    Bochum, 44791
    Germany

    Site Not Available

  • Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Universitatsklinikum Dresden Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Dresden Carl Gustav Carus

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt, 60950
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt 2925536, 60950
    Germany

    Site Not Available

  • "Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"

    München, 80337
    Germany

    Site Not Available

  • "Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"

    München 2867711, 80337
    Germany

    Site Not Available

  • General University Hospital "Attikon"

    Athens, 12462
    Greece

    Site Not Available

  • General University Hospital "Attikon"

    Athens 264371, 12462
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "Papageorgiou"

    Thessaloniki 734077, 56403
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "Papageorgiou"

    Thessaloníki, 56403
    Greece

    Site Not Available

  • Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny

    Lodz, 90-153
    Poland

    Site Not Available

  • Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny

    Lodz 3093133, 90-153
    Poland

    Site Not Available

  • Labderm Essence sp.

    Ossy, 42-624
    Poland

    Site Not Available

  • Labderm Essence sp.

    Ossy 3089794, 42-624
    Poland

    Site Not Available

  • "Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"

    Wroclaw 3081368, 50-566
    Poland

    Site Not Available

  • "Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"

    Wrocław, 50-566
    Poland

    Site Not Available

  • First OC Dermatology Research Inc.

    Fountain Valley, California 92708
    United States

    Site Not Available

  • First OC Dermatology Research Inc.

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Ziaderm Research LLC

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Ziaderm Research LLC

    North Miami Beach 4166233, Florida 4155751 33162
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Site Not Available

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky 42071
    United States

    Site Not Available

  • Kentucky Advanced Medical Research LLC

    Murray 4302035, Kentucky 6254925 42071
    United States

    Site Not Available

  • MediSearch LLC

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • MediSearch LLC

    Saint Joseph 4407010, Missouri 4398678 64506
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens 5123344, New York 5128638 11415
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn 4511263, Ohio 5165418 45324
    United States

    Site Not Available

  • Progressive Clinical Research, PA

    Texas City, Texas 78213
    United States

    Site Not Available

  • Progressive Clinical Research, PA

    Texas City 4736134, Texas 4736286 78213
    United States

    Site Not Available

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