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

Last updated: April 30, 2025
Sponsor: InflaRx GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Urticaria

Hives (Urticaria)

Hidradenitis Suppurativa

Treatment

HS 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: 75
Treatment Group(s): 6
Primary Treatment: HS high dose treatment
Phase: 2
Study Start date:
January 02, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Medical Center Medconsult, Pleven OOD

    Lovech, 5500
    Bulgaria

    Active - Recruiting

  • Medical Center Medconsult pleven OOD

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Medical Center Etika

    Plovdiv, 4200
    Bulgaria

    Active - Recruiting

  • ASMC IPSMC Skin and Venereal Diseases,

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Medical Center Excelsior OOD,

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • LTD "Health"

    Batumi, 6010
    Georgia

    Active - Recruiting

  • LLC "Aversi Clinic"

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • LLC "Center of Allergy and Immunology"

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Labderm Essence sp.

    Ossy, 42-624
    Poland

    Active - Recruiting

  • First OC Dermatology Research Inc.

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Ziaderm Research LLC

    North Miami Beach, Florida 33162
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky 42071
    United States

    Active - Recruiting

  • MediSearch LLC

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Active - Recruiting

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

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