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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2026-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Urticaria, Idiopathic Hidradenitis Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 CSU

Lower dose of IFN904 BID

Group Type EXPERIMENTAL

CSU lower dose treatment

Intervention Type DRUG

CSU lower dose treatment

Arm 2 CSU

Higher dose of IFN904 BID

Group Type EXPERIMENTAL

CSU high dose treatment

Intervention Type DRUG

CSU high dose treatment

Arm 3 CSU

Non responders IgE, higher dose of IFN904 BID

Group Type EXPERIMENTAL

CSU non responders IgE - high dose treatment

Intervention Type DRUG

CSU non responders IgE - high dose treatment

Arm 4 HS

Lower dose of IFN904 BID

Group Type EXPERIMENTAL

HS low dose treatment

Intervention Type DRUG

HS low dose treatment

Arm 5 HD

Medium dose of IFN904 BID

Group Type EXPERIMENTAL

HS medium dose treatment

Intervention Type DRUG

HS medium dose treatment

Arm 6 HD

High dose of IFN904 BID

Group Type EXPERIMENTAL

HS high dose treatment

Intervention Type DRUG

HS high dose treatment

Interventions

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CSU lower dose treatment

CSU lower dose treatment

Intervention Type DRUG

CSU high dose treatment

CSU high dose treatment

Intervention Type DRUG

CSU non responders IgE - high dose treatment

CSU non responders IgE - high dose treatment

Intervention Type DRUG

HS low dose treatment

HS low dose treatment

Intervention Type DRUG

HS medium dose treatment

HS medium dose treatment

Intervention Type DRUG

HS high dose treatment

HS high dose treatment

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InflaRx GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First OC Dermatology Research Inc.

Fountain Valley, California, United States

Site Status

Ziaderm Research LLC

North Miami Beach, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Kentucky Advanced Medical Research LLC

Murray, Kentucky, United States

Site Status

MediSearch LLC

Saint Joseph, Missouri, United States

Site Status

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Site Status

Wright State Physicians

Fairborn, Ohio, United States

Site Status

Progressive Clinical Research, PA

Texas City, Texas, United States

Site Status

Medical Center Medconsult, Pleven OOD

Lovech, , Bulgaria

Site Status

Medical Center Medconsult pleven OOD

Pleven, , Bulgaria

Site Status

Medical Center Etika

Plovdiv, , Bulgaria

Site Status

ASMC IPSMC Skin and Venereal Diseases,

Sofia, , Bulgaria

Site Status

Medical Center Excelsior OOD,

Sofia, , Bulgaria

Site Status

LTD "Health"

Batumi, , Georgia

Site Status

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, , Georgia

Site Status

LLC "Center of Allergy and Immunology"

Tbilisi, , Georgia

Site Status

LLC "Aversi Clinic"

Tbilisi, , Georgia

Site Status

"Institut Allergieforschung Charité - Universitatsmedizin Berlin"

Berlin, , Germany

Site Status

Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie

Bochum, , Germany

Site Status

Universitatsklinikum Dresden Carl Gustav Carus

Dresden, , Germany

Site Status

Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, , Germany

Site Status

"Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"

München, , Germany

Site Status

General University Hospital "Attikon"

Athens, , Greece

Site Status

General Hospital of Thessaloniki "Papageorgiou"

Thessaloniki, , Greece

Site Status

Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.

Gdansk, , Poland

Site Status

Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny

Lodz, , Poland

Site Status

Labderm Essence sp.

Ossy, , Poland

Site Status

"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"

Wroclaw, , Poland

Site Status

Countries

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United States Bulgaria Georgia Germany Greece Poland

Other Identifiers

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INF904- P2.1

Identifier Type: -

Identifier Source: org_study_id

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