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

Description

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

Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa

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Study Overview

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Study Details

Study overview

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.

Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

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

Condition
Chronic Urticaria, Idiopathic
Intervention / Treatment

-

Contacts and Locations

Tampa

ForCare Clinical Research, Tampa, Florida, United States, 33613

Saint Joseph

MediSearch LLC, Saint Joseph, Missouri, United States, 64506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InflaRx GmbH,

Study Record Dates

2025-12