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

January 30, 2026 updated by: InflaRx GmbH

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Lovech, Bulgaria, 5500
        • Medical Center Medconsult, Pleven OOD
      • Pleven, Bulgaria, 5800
        • Medical Center Medconsult Pleven Ood
      • Plovdiv, Bulgaria, 4200
        • Medical Center Etika
      • Sofia, Bulgaria, 1407
        • ASMC IPSMC Skin and Venereal Diseases,
      • Sofia, Bulgaria, 1407
        • Medical Center Excelsior OOD,
  • Georgia
      • Batumi, Georgia, 6010
        • Ltd "Health"
      • Tbilisi, Georgia, 0112
        • LTD "Israel-Georgian Medical Research Clinic Healthycore"
      • Tbilisi, Georgia, 0159
        • LLC "Center of Allergy and Immunology"
      • Tbilisi, Georgia, 0160
        • LLC "Aversi Clinic"
  • Germany
      • Berlin, Germany, 12203
        • "Institut Allergieforschung Charité - Universitatsmedizin Berlin"
      • Bochum, Germany, 44791
        • Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie
      • Dresden, Germany, 01307
        • Universitatsklinikum Dresden Carl Gustav Carus
      • Frankfurt, Germany, 60950
        • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
      • München, Germany, 80337
        • "Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"
  • Greece
      • Athens, Greece, 12462
        • General University Hospital "Attikon"
      • Thessaloniki, Greece, 56403
        • General Hospital of Thessaloniki "Papageorgiou"
  • Poland
      • Gdansk, Poland, 80-214
        • Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.
      • Lodz, Poland, 90-153
        • Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny
      • Ossy, Poland, 42-624
        • Labderm Essence sp.
      • Wroclaw, Poland, 50-566
        • "Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology Research Inc.
    • Florida
      • North Miami Beach, Florida, United States, 33162
        • Ziaderm Research LLC
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Kentucky Advanced Medical Research LLC
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch LLC
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hills Dermatology Group
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
    • Texas
      • Texas City, Texas, United States, 78213
        • Progressive Clinical Research, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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:

    1. Any infection requiring systemic treatment within 14 days prior to baseline.
    2. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 CSU
Lower dose of IFN904 BID
Drug: CSU lower dose treatment
CSU lower dose treatment
Experimental: Arm 2 CSU
Higher dose of IFN904 BID
Drug: CSU high dose treatment
CSU high dose treatment
Experimental: Arm 3 CSU
Non responders IgE, higher dose of IFN904 BID
Drug: CSU non responders IgE - high dose treatment
CSU non responders IgE - high dose treatment
Experimental: Arm 4 HS
Lower dose of IFN904 BID
Drug: HS low dose treatment
HS low dose treatment
Experimental: Arm 5 HD
Medium dose of IFN904 BID
Drug: HS medium dose treatment
HS medium dose treatment
Experimental: Arm 6 HD
High dose of IFN904 BID
Drug: HS high dose treatment
HS high dose treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time Frame: Through study completion, an average of 10 weeks
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.
Through study completion, an average of 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration [Cmax]
Time Frame: Through study completion, an average of 10 weeks
Plasma PK parameters of INF904
Through study completion, an average of 10 weeks
Minimum Plasma Concentration [Cmin]
Time Frame: Through study completion, an average of 10 weeks
Plasma PK parameters of INF904
Through study completion, an average of 10 weeks
Time of occurrence of maximum plasma concentration [tmax]
Time Frame: Through study completion, an average of 10 weeks
Plasma PK parameters of INF904
Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
Time Frame: Through study completion, an average of 10 weeks
Plasma PK parameters of INF904
Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUClast]
Time Frame: Through study completion, an average of 10 weeks
Plasma PK parameters of INF904
Through study completion, an average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InflaRx GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

January 22, 2026

Study Completion (Actual)

January 22, 2026

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF904- P2.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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