INF904 for Chronic Urticaria and Hidradenitis Suppurativa

Recruiting at 17 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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug INF904 for treating chronic urticaria and hidradenitis suppurativa?

Research shows that targeting certain immune pathways, like those involving mast cells and cytokines (proteins important in cell signaling), can help manage hidradenitis suppurativa. Treatments that block these pathways, such as spleen tyrosine kinase antagonists, have shown promise in reducing inflammation and improving symptoms in similar conditions. ^{1 2 3 4 5}

How does the drug INF904 differ from other treatments for chronic urticaria and hidradenitis suppurativa?

The drug INF904 may offer a novel approach by potentially targeting specific immune pathways involved in chronic urticaria and hidradenitis suppurativa, which are conditions linked to immune system dysregulation. Unlike some existing treatments that focus on general inflammation, INF904 might specifically address the role of mast cells and other immune components in these conditions. ^{1 2 4 6 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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)

Findings from Research

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]

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]

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]

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Mast cells are upregulated in hidradenitis suppurativa tissue, associated with epithelialized tunnels and normalized by spleen tyrosine kinase antagonism. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Dysregulated CD38 expression in blood and skin immune cells of patients with hidradenitis suppurativa. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Treatment of Recalcitrant Hidradenitis Suppurativa with Adalimumab. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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