Evaluating a new treatment for chronic spontaneous urticaria and hidradenitis suppurativa
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
PHASE2 · InflaRx GmbH · NCT06555328
This study is testing a new medication for people with moderate to severe chronic hives or hidradenitis suppurativa to see if it helps their symptoms and is safe to use.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | InflaRx GmbH (industry) |
| Locations | 18 sites (Fountain Valley, California and 17 other locations) |
| Trial ID | NCT06555328 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and pharmacokinetics of INF904 in patients suffering from moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa. Participants will undergo a screening phase followed by a 28-day treatment period with different dosing regimens, and an observational follow-up period of 28 days. The study will assess the drug's effects on these conditions and monitor any adverse reactions. The trial is designed to gather data on how well the treatment works and its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa.
Not a fit: Patients with severe hypersensitivity reactions to existing treatments or other skin diseases that interfere with assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic spontaneous urticaria and hidradenitis suppurativa.
How similar studies have performed: Other studies have shown promise in treating chronic spontaneous urticaria and hidradenitis suppurativa with novel therapies, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Fountain Valley, California and 17 other locations
- First OC Dermatology Research Inc. — Fountain Valley, California, United States (RECRUITING)
- Ziaderm Research LLC — North Miami Beach, Florida, United States (RECRUITING)
- ForCare Clinical Research — Tampa, Florida, United States (RECRUITING)
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (RECRUITING)
- Kentucky Advanced Medical Research LLC — Murray, Kentucky, United States (RECRUITING)
- MediSearch LLC — Saint Joseph, Missouri, United States (RECRUITING)
- Forest Hills Dermatology Group — Kew Gardens, New York, United States (RECRUITING)
- Wright State Physicians — Fairborn, Ohio, United States (RECRUITING)
- Medical Center Medconsult, Pleven OOD — Lovech, Bulgaria (RECRUITING)
- Medical Center Medconsult pleven OOD — Pleven, Bulgaria (RECRUITING)
- Medical Center Etika — Plovdiv, Bulgaria (RECRUITING)
- ASMC IPSMC Skin and Venereal Diseases, — Sofia, Bulgaria (RECRUITING)
- Medical Center Excelsior OOD, — Sofia, Bulgaria (RECRUITING)
- LTD "Health" — Batumi, Georgia (RECRUITING)
- LTD "Israel-Georgian Medical Research Clinic Healthycore" — Tbilisi, Georgia (RECRUITING)
- LLC "Center of Allergy and Immunology" — Tbilisi, Georgia (RECRUITING)
- LLC "Aversi Clinic" — Tbilisi, Georgia (RECRUITING)
- Labderm Essence sp. — Ossy, Poland (RECRUITING)
Study contacts
- Study coordinator: Eva Wagner, PhD
- Email: clinicaltrials@inflarx.de; clinicaltrials@inflarx.com
- Phone: +49 (0) 3641 508 180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa