A Phase 2 interventional study of CSU lower dose treatment and CSU high dose treatment in Chronic Urticaria, Idiopathic, Hidradenitis and Hidradenitis Suppurativa, sponsored by InflaRx GmbH. Terminated at 29 sites in 6 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment
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.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 73 is close to the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who have an active infection or history of infection(s) as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lower dose of IFN904 BID
Drug: CSU lower dose treatment
Higher dose of IFN904 BID
Drug: CSU high dose treatment
Non responders IgE, higher dose of IFN904 BID
Drug: CSU non responders IgE - high dose treatment
Lower dose of IFN904 BID
Drug: HS low dose treatment
Medium dose of IFN904 BID
Drug: HS medium dose treatment
High dose of IFN904 BID
Drug: HS high dose treatment
CSU lower dose treatment
CSU high dose treatment
CSU non responders IgE - high dose treatment
HS low dose treatment
HS medium dose treatment
HS high dose treatment
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.
Time frame: Through study completion, an average of 10 weeks
Maximum Plasma Concentration [Cmax]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Minimum Plasma Concentration [Cmin]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Time of occurrence of maximum plasma concentration [tmax]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUClast]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Jan 2026, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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InflaRx GmbH