Clinical trial NCT06555328: Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Urticaria, Idiopathic
Hidradenitis
Hidradenitis Suppurativa
Lead sponsor: InflaRx GmbH
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
timeFrame: Through study completion, an average of 10 weeks
Secondary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Through study completion, an average of 10 weeks
measure: Minimum Plasma Concentration [Cmin]
timeFrame: Through study completion, an average of 10 weeks
measure: Time of occurrence of maximum plasma concentration [tmax]
timeFrame: Through study completion, an average of 10 weeks
measure: Systemic exposure, defined as the Area Under the Curve [AUC0-24]
timeFrame: Through study completion, an average of 10 weeks
measure: Systemic exposure, defined as the Area Under the Curve [AUClast]
timeFrame: Through study completion, an average of 10 weeks
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc.
state: California
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Murray
country: United States
facility: Kentucky Advanced Medical Research LLC
state: Kentucky
city: Saint Joseph
country: United States
facility: MediSearch LLC
state: Missouri
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Lovech
country: Bulgaria
facility: Medical Center Medconsult, Pleven OOD
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult pleven OOD
city: Plovdiv
country: Bulgaria
facility: Medical Center Etika
city: Sofia
country: Bulgaria
facility: ASMC IPSMC Skin and Venereal Diseases,
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD,
city: Batumi
country: Georgia
facility: LTD "Health"
city: Tbilisi
country: Georgia
facility: LTD "Israel-Georgian Medical Research Clinic Healthycore"
city: Tbilisi
country: Georgia
facility: LLC "Center of Allergy and Immunology"
city: Tbilisi
country: Georgia
facility: LLC "Aversi Clinic"
city: Ossy
country: Poland
facility: Labderm Essence sp.
Study officials:
References: