RECRUITING

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

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Conditions

Chronic Urticaria, IdiopathicHidradenitisHidradenitis Suppurativa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555328

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent.
  2. * Subjects must be 18 years or older at the time of signing the informed consent.
  1. * 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).
  2. * Subjects who have any other skin disease that may interfere with assessment of CSU or HS.
  3. * Subjects who have an active infection or history of infection(s) as follows:
  4. 1. Any infection requiring systemic treatment within 14 days prior to baseline.
  5. 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.
  6. * Subjects with known progressed liver disease (Child-Pugh B or C)

Contacts and Locations

Study Contact

Dorothee Neukirchen, PhD
CONTACT
+49 (0) 3641 508 180
clinicaltrials@inflarx.de; clinicaltrials@inflarx.com

Study Locations (Sites)

ForCare Clinical Research
Tampa, Florida, 33613
United States
MediSearch LLC
Saint Joseph, Missouri, 64506
United States

Collaborators and Investigators

Sponsor: InflaRx GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01-02
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Urticaria, Idiopathic
  • Hidradenitis
  • Hidradenitis Suppurativa