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

InflaRx

Status and phase: Enrolling; Phase 2

Conditions: Hidradenitis; Chronic Urticaria, Idiopathic; Hidradenitis Suppurativa

Treatments: Drug: CSU high dose treatment; Drug: CSU lower dose treatment; Drug: CSU non responders IgE - high dose treatment; Drug: HS high dose treatment; Drug: HS medium dose treatment; Drug: HS low dose treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06555328

INF904- P2.1

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 6 patient groups

Arm 1 CSU

Experimental group

Description:

Lower dose of IFN904 BID

Treatment:

Drug: CSU lower dose treatment

Arm 2 CSU

Experimental group

Description:

Higher dose of IFN904 BID

Treatment:

Drug: CSU high dose treatment

Arm 3 CSU

Experimental group

Description:

Non responders IgE, higher dose of IFN904 BID

Treatment:

Drug: CSU non responders IgE - high dose treatment

Arm 4 HS

Experimental group

Description:

Lower dose of IFN904 BID

Treatment:

Drug: HS low dose treatment

Arm 5 HD

Experimental group

Description:

Medium dose of IFN904 BID

Treatment:

Drug: HS medium dose treatment

Arm 6 HD

Experimental group

Description:

High dose of IFN904 BID

Treatment:

Drug: HS high dose treatment