Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa
Conditions
Brief 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.
Interventions
DRUGCSU lower dose treatment
CSU lower dose treatment
DRUGCSU high dose treatment
CSU high dose treatment
DRUGCSU non responders IgE - high dose treatment
CSU non responders IgE - high dose treatment
DRUGHS low dose treatment
HS low dose treatment
DRUGHS medium dose treatment
HS medium dose treatment
DRUGHS high dose treatment
HS high dose treatment
Sponsors
InflaRx GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Through study completion, an average of 10 weeks | Plasma PK parameters of INF904 |
| Minimum Plasma Concentration [Cmin] | Through study completion, an average of 10 weeks | Plasma PK parameters of INF904 |
| Time of occurrence of maximum plasma concentration [tmax] | Through study completion, an average of 10 weeks | Plasma PK parameters of INF904 |
| Systemic exposure, defined as the Area Under the Curve [AUC0-24] | Through study completion, an average of 10 weeks | Plasma PK parameters of INF904 |
| Systemic exposure, defined as the Area Under the Curve [AUClast] | Through study completion, an average of 10 weeks | Plasma PK parameters of INF904 |
Countries
Bulgaria, Georgia, Germany, Greece, Poland, United States
Outcome results
None listed