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

Phase 2

Recruiting

• Conditions: Chronic Urticaria, Idiopathic; Hidradenitis; Hidradenitis Suppurativa
• Interventions: Drug: HS medium dose treatment; Drug: HS low dose treatment; Drug: HS high dose treatment; Drug: CSU high dose treatment; Drug: CSU non responders IgE - high dose treatment; Drug: CSU lower dose treatment

• Registration Number: NCT06555328
• Lead Sponsor: InflaRx GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Status Verified: 2025-01
• Study Start: 2025-01-02
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 5 HD	HS medium dose treatment	Medium dose of IFN904 BID
Arm 4 HS	HS low dose treatment	Lower dose of IFN904 BID
Arm 6 HD	HS high dose treatment	High dose of IFN904 BID
Arm 2 CSU	CSU high dose treatment	Higher dose of IFN904 BID
Arm 3 CSU	CSU non responders IgE - high dose treatment	Non responders IgE, higher dose of IFN904 BID
Arm 1 CSU	CSU lower dose treatment	Lower dose of IFN904 BID

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Systemic exposure, defined as the Area Under the Curve [AUC0-24]	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
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
Systemic exposure, defined as the Area Under the Curve [AUClast]	Through study completion, an average of 10 weeks	Plasma PK parameters of INF904

Trial Locations

Locations (2)

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

MediSearch LLC; 🇺🇸 Saint Joseph, Missouri, United States