Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
NCT ID: NCT06555328
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
73 participants
INTERVENTIONAL
2025-01-02
2026-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 CSU
Lower dose of IFN904 BID
CSU lower dose treatment
CSU lower dose treatment
Arm 2 CSU
Higher dose of IFN904 BID
CSU high dose treatment
CSU high dose treatment
Arm 3 CSU
Non responders IgE, higher dose of IFN904 BID
CSU non responders IgE - high dose treatment
CSU non responders IgE - high dose treatment
Arm 4 HS
Lower dose of IFN904 BID
HS low dose treatment
HS low dose treatment
Arm 5 HD
Medium dose of IFN904 BID
HS medium dose treatment
HS medium dose treatment
Arm 6 HD
High dose of IFN904 BID
HS high dose treatment
HS high dose treatment
Interventions
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CSU lower dose treatment
CSU lower dose treatment
CSU high dose treatment
CSU high dose treatment
CSU non responders IgE - high dose treatment
CSU non responders IgE - high dose treatment
HS low dose treatment
HS low dose treatment
HS medium dose treatment
HS medium dose treatment
HS high dose treatment
HS high dose treatment
Eligibility Criteria
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Inclusion Criteria
* Subjects must be 18 years or older at the time of signing the informed consent.
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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InflaRx GmbH
INDUSTRY
Responsible Party
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Locations
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First OC Dermatology Research Inc.
Fountain Valley, California, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States
MediSearch LLC
Saint Joseph, Missouri, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Wright State Physicians
Fairborn, Ohio, United States
Progressive Clinical Research, PA
Texas City, Texas, United States
Medical Center Medconsult, Pleven OOD
Lovech, , Bulgaria
Medical Center Medconsult pleven OOD
Pleven, , Bulgaria
Medical Center Etika
Plovdiv, , Bulgaria
ASMC IPSMC Skin and Venereal Diseases,
Sofia, , Bulgaria
Medical Center Excelsior OOD,
Sofia, , Bulgaria
LTD "Health"
Batumi, , Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, , Georgia
LLC "Center of Allergy and Immunology"
Tbilisi, , Georgia
LLC "Aversi Clinic"
Tbilisi, , Georgia
"Institut Allergieforschung Charité - Universitatsmedizin Berlin"
Berlin, , Germany
Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie
Bochum, , Germany
Universitatsklinikum Dresden Carl Gustav Carus
Dresden, , Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, , Germany
"Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"
München, , Germany
General University Hospital "Attikon"
Athens, , Greece
General Hospital of Thessaloniki "Papageorgiou"
Thessaloniki, , Greece
Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.
Gdansk, , Poland
Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny
Lodz, , Poland
Labderm Essence sp.
Ossy, , Poland
"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"
Wroclaw, , Poland
Countries
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Other Identifiers
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INF904- P2.1
Identifier Type: -
Identifier Source: org_study_id
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