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    Summary
    EudraCT Number:2020-003273-21
    Sponsor's Protocol Code Number:IFX-1-P2.7
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-003273-21
    A.3Full title of the trial
    Open label exploratory phase IIa trial to investigate the safety and efficacy of IFX-1 in treating subjects with Pyoderma Gangrenosum (OPTIMA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    Exploratory study of IFX-1 in Subjects with Pyoderma Gangrenosum
    A.4.1Sponsor's protocol code numberIFX-1-P2.7
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInflaRx GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInflaRx GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInflaRx GmbH
    B.5.2Functional name of contact pointClinical Research and Development
    B.5.3 Address:
    B.5.3.1Street AddressWinzerlaer Strasse 2
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07745
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989414 189 78 25
    B.5.5Fax number+493641508 181
    B.5.6E-mailinfo@inflarx.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIFX-1
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2250440-41-4
    D.3.9.2Current sponsor codeIFX-1
    D.3.9.3Other descriptive nameAnti-(complement C5a) IgG4 chimeric monoclonal antibody
    D.3.9.4EV Substance CodeSUB193626
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIFX-1
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2250440-41-4
    D.3.9.2Current sponsor codeIFX-1
    D.3.9.3Other descriptive nameAnti-(complement C5a) IgG4 chimeric monoclonal antibody
    D.3.9.4EV Substance CodeSUB193626
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pyoderma gangrenosum
    E.1.1.1Medical condition in easily understood language
    Pyoderma gangrenosum
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037635
    E.1.2Term Pyoderma gangrenosum
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Explore the safety of IFX-1 for the treatment of subjects with pyoderma gangrenosum
    E.2.2Secondary objectives of the trial
    Explore the efficacy of IFX-1 for the treatment of pyoderma gangrenosum
    Explore additional clinical outcome parameters in subjects with pyoderma gangrenosum under the treatment with IFX-1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Capable of giving signed informed consent as described in Regulatory and Ethical Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, and approval for photographic documentation
    2. Subjects must be 18 years or older, at the time of signing the informed consent
    3. Male or female
    4.Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator
    5.In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:History of
    •Pathergy (ulcer occurring at the sites of trauma)
    •Personal history of inflammatory bowel disease or inflammatory arthritis
    •History of papule, pustule or vesicle that rapidly ulcerated
    Clinical examination (or photographic evidence) of
    •Peripheral erythema, undermining border, and tenderness at site of ulceration
    •Multiple ulcerations
    •Cribriform or “wrinkled paper” scar(s) at sites of healed ulcers
    6.Subject has a minimum of 1 evaluable ulcer (≥2 cm2) at screening
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria apply:
    1.Pyoderma gangrenosum target ulcer for more than 3 years before screening
    2.Surgical wound debridement within the previous 2 weeks before screening
    3.Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
    4.Poor general condition that might affect wound healing, as determined by the investigator
    5.One of the following abnormal laboratory findings at screening:
    •White blood cell count <3500/mm3
    •Platelet count <100,000/mm3
    •Hemoglobin <7 g/dL
    •Total bilirubin >1.5 times the upper limit of normal and/or alanine aminotransferase or aspartate aminotransferase >2.5 times upper limit of normal
    6.Human immunodeficiency virus, hepatitis B or hepatitis C viral screening test showing evidence of active or chronic viral infection at screening or a documented history of the human immunodeficiency virus, hepatitis B, or hepatitis C
    7.Evidence of active or latent tuberculosis
    8.History of malignancy in the previous 5 years (except for non-melanoma skin cancer and cancer in-situ of the cervix)
    9.Subjects with ulceration due to medical causes other than pyoderma gangrenosum (e.g. diabetic ulceration)
    10.Infection requiring suppressive anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
    11.Use of intravenous antibacterial, antiviral, anti-fungal, or anti-parasitic agents within 30 days before screening
    12.Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg prednisone or prednisone equivalent), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
    13.Received live attenuated vaccine within the previous 3 months before screening
    14.Major surgery planned during the time of foreseen study participation
    15.The subject has participated in an interventional clinical study during the 3 months before screening, or plans to participate in a clinical study
    16.Previous exposure to IFX-1 in this or another study
    17.Known hypersensitivity to polysorbate 80 (excipient of the IMP)
    18.Prior exposure to anticomplement 5a before screening
    19.History of sever anaphylactic reaction to any components of C5a before screening
    20.Known or suspected active drug and/or alcohol abuse at screening
    21.Breast feeding or pregnant woman at screening
    22.Male and female subjects of childbearing potential unwilling to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of IMP
    23.Pregnancy or positive pregnancy test at screening
    24.The subject is imprisoned or lawfully kept in an institution at screening
    25.Evidence or suspicion that the subject might not comply with the requirements of the study protocol
    26.The subject is an employee or direct relative of an employee at the study site or sponsor
    27.Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence, nature and intensity of treatment emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse Events are assessed at every visit; interim analysis and End of Trial
    E.5.2Secondary end point(s)
    Responder rate defined as Physician’s Global Assessment ≤3 of target ulcer at Visits V4, V6, V10, and V16 (End of Treatment [EOT])
    Time to complete closure of pyoderma gangrenosum target ulcer (investigator assessment)
    Percentage change in wound area and wound volume (wound healing) of target ulcer between Visits V1-V4, V1-V6, V6-V10; V10-V16, and V1-V16 (photographic assessment)
    Rate of change per day in area of target ulcer (photographic assessment)
    Number of subjects with a decrease in area of target ulcer of 50% or more at Visit V16 (EOT) compared to baseline (photographic assessment)
    Number of subjects with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to baseline (remission) (photographic assessment)
    Degree of erythema and border elevation of the target ulcer compared to baseline at Visits V4, V6, V10, and V16 (EOT) (investigator assessment)
    Mean change from baseline in pain assessed by Numeric Rating Scale (NRS) at Visits V4, V6, V10, and V16 (EOT)
    Mean change from baseline in Dermatology Life Quality Index (DLQI) at Visits V4, V6, V10, and V16 (EOT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis and End of trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    staggered dose increase
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    3 dosing groups: 800, 1600 or 2400mg
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    subjects should receive treatment for pyoderma gangrenosum at the discretion of the investigator
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-03
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