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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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