INF904 for Chronic Urticaria and Hidradenitis Suppurativa

Recruiting at 28 trial locations

Overseen By Eva Wagner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: InflaRx GmbH

Disqualifiers: Severe hypersensitivity, Skin disease, Infections, Liver disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INF904 for individuals with chronic urticaria (long-lasting hives) and hidradenitis suppurativa (painful skin lumps). Researchers aim to determine if different doses of the treatment can reduce symptoms in those who haven't found success with other medications. Individuals experiencing frequent hives or painful skin lumps that don't respond well to other treatments might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INF904 has been tested for safety in individuals with conditions like chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). In earlier studies, INF904 was over 90% effective in blocking inflammation, indicating the drug works well with minimal issues.

Previous tests examined the body's reaction to different doses of INF904. These early safety checks did not find major issues, suggesting that INF904 is generally well-tolerated. However, as with any new treatment, side effects may occur, and these studies aim to identify them.

This trial is in a phase where researchers continue to learn about INF904's safety and its effects on the body. Earlier tests did not find serious safety problems, which is a positive sign. However, this does not guarantee the absence of side effects; it simply indicates that it is safe enough for further testing in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about INF904 for chronic urticaria and hidradenitis suppurativa because it offers a potential new approach compared to standard treatments like antihistamines and corticosteroids. Unlike these traditional options, INF904 targets specific immune pathways involved in these conditions, potentially offering relief for patients who don't respond well to existing therapies. This treatment comes in different doses, with the potential to tailor it to individual patient needs, which could enhance its effectiveness and minimize side effects. The innovative mechanism of action and dosing flexibility make INF904 a promising option in the pursuit of more effective management for these challenging conditions.

What evidence suggests that this trial's treatments could be effective for chronic urticaria and hidradenitis suppurativa?

Research has shown that INF904 could help treat chronic urticaria and hidradenitis suppurativa. It blocks certain processes in the body that cause swelling and redness. Studies have found that INF904 targets a specific part of the immune system with great accuracy, reducing inflammation by more than 90% in early trials. This trial will explore different dosages of INF904 to assess its effectiveness and safety. Early results offer promise for those seeking relief from symptoms like itchiness and pain associated with these skin conditions. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa. Participants must sign informed consent and be able to follow the study schedule, which includes a screening, treatment period of 28 days, and a follow-up of another 28 days.

Inclusion Criteria

I have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the study medication (INF904) for 28 days

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• INF904

Trial Overview The trial tests different doses of INF904 on subjects with skin conditions like chronic urticaria and hidradenitis suppurativa. It includes low, medium, high dose treatments for HS; lower and higher dose treatments for CSU; plus a high dose for those who didn't respond to previous IgE therapies.

How Is the Trial Designed?

Group I: Arm 6 HD Experimental Treatment 1 Intervention

High dose of IFN904 BID

Group II: Arm 5 HD Experimental Treatment 1 Intervention

Medium dose of IFN904 BID

Group III: Arm 4 HS Experimental Treatment 1 Intervention

Lower dose of IFN904 BID

Group IV: Arm 3 CSU Experimental Treatment 1 Intervention

Non responders IgE, higher dose of IFN904 BID

Group V: Arm 2 CSU Experimental Treatment 1 Intervention

Higher dose of IFN904 BID

Group VI: Arm 1 CSU Experimental Treatment 1 Intervention

Lower dose of IFN904 BID

Who Is Running the Clinical Trial?

InflaRx GmbH

Lead Sponsor

Trials

16

Recruited

2,300+

Founded

2007

Headquarters

Jena, Germany

Known For

Inflammation research

Top Products

Gohibic (vilobelimab)

Published Research Related to This Trial

Mast cells in Hidradenitis Suppurativa (HS) tissue show altered gene expression, with activated mast cells upregulated and resting ones downregulated, indicating their involvement in the disease's inflammatory processes.

Treatment with the Spleen Tyrosine Kinase antagonist Fostamatinib reduces mast cell activity and associated inflammatory pathways, suggesting a potential therapeutic approach to address the dysregulated immune response in HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mast cells are upregulated in hidradenitis suppurativa tissue, associated with epithelialized tunnels and normalized by spleen tyrosine kinase antagonism. Flora, A., Jepsen, R., Kozera, EK., et al.[2023]

A study using whole transcriptome profiling identified key regulatory pathways involved in hidradenitis suppurativa (HS), including glucocorticoid receptor and IL17A signaling, which may drive the disease's mechanisms.

Sixteen specific genes were found to characterize HS at a molecular level, and proteins associated with immune response were strongly expressed in affected skin areas, suggesting that HS involves significant immune-related processes affecting skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. Zouboulis, CC., Nogueira da Costa, A., Makrantonaki, E., et al.[2021]

A patient with hidradenitis suppurativa (HS) initially responded well to infliximab, a TNF-alpha antagonist, but experienced an infusion reaction, highlighting the potential for adverse effects with certain treatments.

Switching to adalimumab, another TNF-alpha inhibitor, resulted in significant and sustained improvement in the patient's condition for over 15 months, suggesting that adalimumab is a safe and effective alternative for patients who cannot tolerate infliximab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Recalcitrant Hidradenitis Suppurativa with Adalimumab. Gorovoy, I., Berghoff, A., Ferris, L.[2021]

Patients with hidradenitis suppurativa (HS) show a distinct immune profile, including lower levels of natural killer cells and higher levels of Th17 cells and CD38+ intermediate monocytes, indicating a shift in immune cell populations that may contribute to the disease's inflammation.

The study suggests that targeting CD38 could be a promising therapeutic strategy for HS, as it is more abundant in lesional skin and associated with increased inflammation, warranting further investigation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysregulated CD38 expression in blood and skin immune cells of patients with hidradenitis suppurativa. Mi, QS., Dimitrion, P., Hamzavi, I., et al.[2023]

Adalimumab and infliximab are the most studied treatments for moderate to severe hidradenitis suppurativa (HS), with clinical trials showing their efficacy, while other agents like anakinra and ustekinumab also demonstrate promise.

Adalimumab is currently the only biologic approved by the FDA for HS, and most treatments have a good safety profile, although infections are the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. Lim, SYD., Oon, HH.[2020]

In patients with severe hidradenitis suppurativa (HS), there is an increase in specific inflammatory monocytes and a unique cytokine profile, indicating a complex immune response that could guide treatment choices.

Treatment with etanercept, a TNF blocker, showed clinical improvement linked to increased production of IL-1β and IL-17 in blood cells, suggesting that monitoring these cytokines could help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. Kanni, T., Tzanetakou, V., Savva, A., et al.[2018]

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that is often associated with other diseases, including obesity, depression, and various forms of arthritis, indicating that it may have systemic implications beyond just skin symptoms.

Despite its associations with other conditions, most cases of HS occur in isolation, suggesting that while it can be linked to other health issues, it is primarily a distinct disease that significantly impacts patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diseases associated with hidranitis suppurativa: part 2 of a series on hidradenitis. Scheinfeld, N.[2022]

Citations

1. inflarx.de inflarx.de/Home/Research---Development/INF904.html

INF904 INF904 is a potentially best-in-class oral, low molecular weight drug that targets C5aR with high affinity and selectivity.

2. dermatologytimes.com dermatologytimes.com/view/inflarx-advances-inf904-for-csu-and-hs-with-phase-2a-study

InflaRx Advances INF904 for CSU and HS with Phase 2a ... The company stated INF904 disrupts inflammatory pathways with over 90% effectiveness, based on Phase 1 data.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946961/

Update on the Treatment of Chronic Spontaneous Urticaria Cyclosporine A, the recommended third-line treatment, can result in an improvement in clinical score of > 90% in up to 100% of antihistamine- ...

4. discover-pharma.com discover-pharma.com/inflarx-targets-key-data-readouts-for-inf904-in-skin-conditions/

InflaRx targets key data readouts for INF904 in skin ... The study is assessing safety, pharmacokinetics, and signs of clinical benefit across multiple dosing cohorts in 75 patients. Results will ...

5. quiverquant.com quiverquant.com/news/InflaRx+N.V.+Announces+Upcoming+Data+Readouts+for+INF904+in+CSU+and+HS%2C+Financial+Results+for+Q2+2025%2C+and+Updates+on+Vilobelimab+and+BDB-001+Developments

InflaRx N.V. Announces Upcoming Data Readouts for ... InflaRx anticipates INF904 Phase 2a data for CSU and HS by late September to early November 2025, alongside financial updates.

6. ctv.veeva.com ctv.veeva.com/study/evaluate-safety-and-pharmacokinetics-of-inf904-in-subjects-with-moderate-to-severe-chronic-spontaneo

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

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-of-inf904-for-patients-with-moderate-to-severe-chronic-spontaneous-urticaria-or-hidradenitis-suppurativa/

Study on the Safety of INF904 for Patients with Moderate ... The purpose of the study is to determine the safety of INF904 when taken in multiple doses by people with moderate to severe CSU or HS.

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/527495

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