Chronic Urticaria, IdiopathicPhase 2NCT06555328
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
A Phase 2 study testing CSU lower dose treatment, CSU high dose treatment and CSU non responders IgE - high dose treatment in people with Chronic Urticaria, Idiopathic and Hidradenitis, run by InflaRx GmbH at 29 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa
- What is being tested?
- CSU lower dose treatment, CSU high dose treatment and CSU non responders IgE - high dose treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 2 Jan 2025to 22 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Subjects must be 18 years or older at the time of signing the informed consent.
Who cannot join
- 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)
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States9 sites
Wright State Physicians
Fairborn, Ohio, 45324
First OC Dermatology Research Inc.
Fountain Valley, California, 92708
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Kentucky Advanced Medical Research LLC
Murray, Kentucky, 42071
Ziaderm Research LLC
North Miami Beach, Florida, 33162
MediSearch LLC
Saint Joseph, Missouri, 64506
ForCare Clinical Research
Tampa, Florida, 33613
Progressive Clinical Research, PA
Texas City, Texas, 78213
Bulgaria5 sites
Medical Center Medconsult, Pleven OOD
Lovech, 5500
Medical Center Medconsult pleven OOD
Pleven, 5800
Medical Center Etika
Plovdiv, 4200
ASMC IPSMC Skin and Venereal Diseases,
Sofia, 1407
Medical Center Excelsior OOD,
Sofia, 1407
Germany5 sites
"Institut Allergieforschung Charité - Universitatsmedizin Berlin"
Berlin, 12203
Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie
Bochum, 44791
Universitatsklinikum Dresden Carl Gustav Carus
Dresden, 01307
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, 60950
"Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"
München, 80337
Georgia4 sites
LTD "Health"
Batumi, 6010
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
LLC "Center of Allergy and Immunology"
Tbilisi, 0159
LLC "Aversi Clinic"
Tbilisi, 0160
Poland4 sites
Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.
Gdansk, 80-214
Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny
Lodz, 90-153
Labderm Essence sp.
Ossy, 42-624
"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"
Wroclaw, 50-566
Greece2 sites
General University Hospital "Attikon"
Athens, 12462
General Hospital of Thessaloniki "Papageorgiou"
Thessaloniki, 56403
About this study
Official title: 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.
- Being tested
- CSU lower dose treatment, CSU high dose treatment, CSU non responders IgE - high dose treatment, HS low dose treatment, HS medium dose treatment
- Medical subject headings
- Chronic Urticaria, Hidradenitis, Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSU lower dose treatmentDrug
CSU lower dose treatment
CSU high dose treatmentDrug
CSU high dose treatment
CSU non responders IgE - high dose treatmentDrug
CSU non responders IgE - high dose treatment
HS low dose treatmentDrug
HS low dose treatment
HS medium dose treatmentDrug
HS medium dose treatment
HS high dose treatmentDrug
HS high dose treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 CSU | Experimental | Lower dose of IFN904 BID Receives: Drug: CSU lower dose treatment |
| Arm 2 CSU | Experimental | Higher dose of IFN904 BID Receives: Drug: CSU high dose treatment |
| Arm 3 CSU | Experimental | Non responders IgE, higher dose of IFN904 BID Receives: Drug: CSU non responders IgE - high dose treatment |
| Arm 4 HS | Experimental | Lower dose of IFN904 BID Receives: Drug: HS low dose treatment |
| Arm 5 HD | Experimental | Medium dose of IFN904 BID Receives: Drug: HS medium dose treatment |
| Arm 6 HD | Experimental | High dose of IFN904 BID Receives: Drug: HS high dose treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.
Measured: Through study completion, an average of 10 weeks
Secondary outcomes (5)
Maximum Plasma Concentration [Cmax]
Plasma PK parameters of INF904
Measured: Through study completion, an average of 10 weeks
Minimum Plasma Concentration [Cmin]
Plasma PK parameters of INF904
Measured: Through study completion, an average of 10 weeks
Time of occurrence of maximum plasma concentration [tmax]
Plasma PK parameters of INF904
Measured: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
Plasma PK parameters of INF904
Measured: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUClast]
Plasma PK parameters of INF904
Measured: Through study completion, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jan 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Urticaria, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- InflaRx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555328
- Sponsor's protocol ID
- INF904- P2.1
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06555328
- Acronym / sponsor ID
- INF904- P2.1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 73 participants (actual)
- Lead sponsor
- InflaRx GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 CSU | Experimental | Drug: CSU lower dose treatmentLower dose of IFN904 BID |
| Arm 2 CSU | Experimental | Drug: CSU high dose treatmentHigher dose of IFN904 BID |
| Arm 3 CSU | Experimental | Drug: CSU non responders IgE - high dose treatmentNon responders IgE, higher dose of IFN904 BID |
| Arm 4 HS | Experimental | Drug: HS low dose treatmentLower dose of IFN904 BID |
| Arm 5 HD | Experimental | Drug: HS medium dose treatmentMedium dose of IFN904 BID |
| Arm 6 HD | Experimental | Drug: HS high dose treatmentHigh dose of IFN904 BID |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent.
- Subjects must be 18 years or older at the time of signing the informed consent.
Key exclusion criteria (6 listed)
- 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:
- Subjects with known progressed liver disease (Child-Pugh B or C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSU lower dose treatmentCSU lower dose treatment | Drug | Arm 1 CSU |
| CSU high dose treatmentCSU high dose treatment | Drug | Arm 2 CSU |
| CSU non responders IgE - high dose treatmentCSU non responders IgE - high dose treatment | Drug | Arm 3 CSU |
| HS low dose treatmentHS low dose treatment | Drug | Arm 4 HS |
| HS medium dose treatmentHS medium dose treatment | Drug | Arm 5 HD |
| HS high dose treatmentHS high dose treatment | Drug | Arm 6 HD |
Primary outcome
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.
5 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Through study completion, an average of 10 weeks
Minimum Plasma Concentration [Cmin]
Time frame: 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
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
Time frame: 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
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSU lower dose treatment, CSU high dose treatment and CSU non responders IgE - high dose treatment in people with Chronic Urticaria, Idiopathic and Hidradenitis, run by InflaRx GmbH at 29 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Bulgaria, Germany, Georgia, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.