Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

NCT06555328 | Terminated Phase 2 FDA Drug

• 1 other identifier: INF904- P2.1
• Study Type: interventional
• Target: 73
• Locations: 6 countries
• Sites: 29

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.

Conditions

Hidradenitis; Chronic Urticaria, Idiopathic; Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 10 weeks

Secondary Outcomes (5)

• Maximum Plasma Concentration [Cmax]

  Through study completion, an average of 10 weeks

• Minimum Plasma Concentration [Cmin]

  Through study completion, an average of 10 weeks

• Time of occurrence of maximum plasma concentration [tmax]

  Through study completion, an average of 10 weeks

• Systemic exposure, defined as the Area Under the Curve [AUC0-24]

  Through study completion, an average of 10 weeks

• Systemic exposure, defined as the Area Under the Curve [AUClast]

  Through study completion, an average of 10 weeks

Study Arms (6)

Arm 1 CSU

EXPERIMENTAL

Lower dose of IFN904 BID

Drug: CSU lower dose treatment

Arm 2 CSU

EXPERIMENTAL

Higher dose of IFN904 BID

Drug: CSU high dose treatment

Arm 3 CSU

EXPERIMENTAL

Non responders IgE, higher dose of IFN904 BID

Drug: CSU non responders IgE - high dose treatment

Arm 4 HS

EXPERIMENTAL

Lower dose of IFN904 BID

Drug: HS low dose treatment

Arm 5 HD

EXPERIMENTAL

Medium dose of IFN904 BID

Drug: HS medium dose treatment

Arm 6 HD

EXPERIMENTAL

High dose of IFN904 BID

Drug: HS high dose treatment

Interventions

CSU non responders IgE - high dose treatment DRUG

CSU non responders IgE - high dose treatment

Arm 3 CSU

HS medium dose treatment DRUG

HS medium dose treatment

Arm 5 HD

HS high dose treatment DRUG

HS high dose treatment

Arm 6 HD

CSU lower dose treatment DRUG

CSU lower dose treatment

Arm 1 CSU

CSU high dose treatment DRUG

CSU high dose treatment

Arm 2 CSU

HS low dose treatment DRUG

HS low dose treatment

Arm 4 HS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Subjects must be 18 years or older at the time of signing the informed consent.

You may not qualify if:

• 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:
• Any infection requiring systemic treatment within 14 days prior to baseline.
• 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)

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (29)

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Kentucky Advanced Medical Research LLC

Murray, Kentucky, 42071, United States

Location

MediSearch LLC

Saint Joseph, Missouri, 64506, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Progressive Clinical Research, PA

Texas City, Texas, 78213, United States

Location

Medical Center Medconsult, Pleven OOD

Lovech, 5500, Bulgaria

Location

Medical Center Medconsult pleven OOD

Pleven, 5800, Bulgaria

Location

Medical Center Etika

Plovdiv, 4200, Bulgaria

Location

ASMC IPSMC Skin and Venereal Diseases,

Sofia, 1407, Bulgaria

Location

Medical Center Excelsior OOD,

Sofia, 1407, Bulgaria

Location

LTD "Health"

Batumi, 6010, Georgia

Location

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, 0112, Georgia

Location

LLC "Center of Allergy and Immunology"

Tbilisi, 0159, Georgia

Location

LLC "Aversi Clinic"

Tbilisi, 0160, Georgia

Location

"Institut Allergieforschung Charité - Universitatsmedizin Berlin"

Berlin, 12203, Germany

Location

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

Bochum, 44791, Germany

Location

Universitatsklinikum Dresden Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, 60950, Germany

Location

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

München, 80337, Germany

Location

General University Hospital "Attikon"

Athens, 12462, Greece

Location

General Hospital of Thessaloniki "Papageorgiou"

Thessaloniki, 56403, Greece

Location

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

Gdansk, 80-214, Poland

Location

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

Lodz, 90-153, Poland

Location

Labderm Essence sp.

Ossy, 42-624, Poland

Location

"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"

Wroclaw, 50-566, Poland

Location

MeSH Terms

Conditions

Chronic Urticaria; Hidradenitis; Hidradenitis Suppurativa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sweat Gland Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 15, 2024
• Study Start: January 2, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (9); BU (5); GE (4); DE (5); PL (4); GR (2)