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Clinical Trials

At InflaRx, we are a team of internationally recognized researchers and clinicians who have dedicated our careers to translating discoveries and expertise into new therapeutic concepts for clinical application.


Visit clinicaltrials.gov to learn more about study participation including eligibility, risks and benefits participation, the informed consent process, questions to ask when considering study participation.


Learn more about InflaRx-sponsored clinical trials below:

 

PYODERMA GANGRAENOSUM (PG)

COMPLETED
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PH.II(a): exploratory study of IFX-1 in subjects with pyoderma gangrenosum

ONGOING
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PH.III: randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum 

HIDRADENITIS SUPPURATIVA (HS)

ONGOING
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PH.IIA: safety and pharmacokinetics of INF904 in subjects with moderate to severe chronic spontaneous urticaria (CSU) or hidradenitis suppurativa (HS)

COMPLETED
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PH.IIB SHINE: efficacy and safety study of IFX-1 in patients with moderate to severe hidradenitis suppurativa (HS)

COMPLETED
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PH.II(a): studying complement inhibition in patients with moderate to severe hidradenitis suppurativa

CHRONIC SPONTANEOUS URTICARIA (CSU)

ONGOING
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PH.IIA: safety and pharmacokinetics of INF904 in subjects with moderate to severe chronic spontaneous urticaria (CSU) or hidradenitis suppurativa (HS)

SEVERE COVID-19

COMPLETED
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PH.II/III PANAMO: randomized, controlled study of IFX-1 in patients with severe COVID-19 pneumonia

PHASE I

COMPLETED
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PH.I: clinical assessment of safety and tolerability of the new monoclonal humanized antibody CaCP29 (formerly IFX-1)

ANCA-ASSOCIATED VASCULITIS (AAV)

COMPLETED
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PH.II IXCHANGE: study of IFX-1 to replace steroids in patients with granulomatosis with polyangiitis and microscopic polyangiitis.

COMPLETED
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PH.II IXPLORE: safety and efficacy study of IFX-1 in add-on to standard of care in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

SEVERE SEPSIS AND SEPTIC SHOCK

COMPLETED
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PH.II SCIENS: studying complement inhibition in early, newly developing septic organ dysfunction

COMPLEX CARDIAC SURGERY

COMPLETED
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PH.II CARDIAC: studying complement inhibition in complex cardiac surgery

CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)

TERMINATED
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PH.II: non-comparative study of IFX-1 alone or IFX-1+pembrolizumab in patients with locally advanced or metastatic cSCC.

EXPANDED ACCESS POLICY

InflaRx is committed to developing promising new therapies targeting the complement system to address the unmet medical needs of patients suffering from serious debilitating or life-threatening inflammatory diseases.  Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe enrollment in our ongoing clinical trials is the safest and most effective way of achieving this goal. We do recognize that some patients will not be eligible for our clinical trials and may wish to access our products through expanded access.


Providing access to our investigational therapies through an expanded access program outside the use in clinical trials is a complex matter and we decided that such access should not be provided unless we can offer reasonable assurance that we will not, in doing so, inadvertently cause harm to patients, nor potentially compromise the development program of the investigational product.


We encourage all patients and physicians who are interested in accessing our investigational medicines to consult their physician regarding the possibility of participating in one of our clinical trials.


InflaRx may revise this expanded access policy at any time. Additionally, the posting of this policy by InflaRx does not serve as a guarantee of access to any specific investigational new drug by any individual patient.


If you have any questions, please reach out to us at info@inflarx.de.  You can find further contact details on the Contact Us page of our website.


Please check back periodically for updates on our Expanded Access Policy.