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    Summary
    EudraCT Number:2016-002988-33
    Sponsor's Protocol Code Number:IFX-1-P2.3
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-14
    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 ConcernedGreece - EOF
    A.2EudraCT number2016-002988-33
    A.3Full title of the trial
    An open label Phase II trial to evaluate the safety of IFX-1 in patients with moderate to severe Hidradenitis suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the safety of study drug, IFX-1, in patients with moderate to severe hidradenitis suppurativa.
    A.4.1Sponsor's protocol code numberIFX-1-P2.3
    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 pointInflaRx GmbH
    B.5.3 Address:
    B.5.3.1Street AddressWinzerlaer Str. 2
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07745
    B.5.3.4CountryGermany
    B.5.4Telephone number+493641 508 180
    B.5.5Fax number+493641 508 181
    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 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.3.8INN - Proposed INNn/a
    D.3.9.2Current sponsor codeIFX-1 (former code: CaCP29)
    D.3.9.3Other descriptive namechimeric monoclonal antibody, IgG4 subtype
    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
    Hidradenitis suppurativa
    E.1.1.1Medical condition in easily understood language
    Skin lesions
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Explore the safety of IFX-1 administered over 8 weeks in patients with moderate to severe hidradenitis suppurativa
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics and pharmacodynamics of IFX-1 in patients with hidradenitis suppurativa as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., HiSCR, DLQI, VAS for disease, VAS for pain, HS-PGA, modified Sartorius Score) for further hypotheses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ≥ 18 years old
    2. Written informed consent
    3. Diagnosis of HS for at least 1 year
    4. HS lesions in at least 2 distinct anatomic areas, one of which isHurley Stage II or III
    5. Total AN (abscesses and nodules) count ≥3
    6. Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals NOTE: a primary failure is defined as an at least 12 week treatment with a biological compound without effect and a secondary failure as achieving an initial response after at least 12 week treatment with a biological compound followed by a relapse.
    7. Failure of previous antimicrobial treatments
    E.4Principal exclusion criteria
    1. Body weight above 150kg or body weight below 60 kg
    2. Has a draining fistula count of greater than 30 at baseline
    3. Surgical management planned within the next 24 weeks
    4. Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days
    5. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
    a) Active infection
    b) Severe congestive heart failure (i.e., NYHA Class IV)
    c) Depression
    d) History of systemic lupus erythematosus or rheumatoid arthritis
    e) Any immunodeficiency disease
    f) Active hematological or solid malignant tumor
    g) Patients must not have had any other active skin disease or condition (e.g., bacterial, fungal, or viral infection) that may have interfered with assessment of HS.
    6. One of the following abnormal laboratory results
    a) White blood cell count < 2,500/mm3
    b) Neutrophil count < 1000/mm3
    c) Serum creatinine > 3 x Upper Normal Limit
    (UNL)
    d) Total bilirubin > 2 x UNL
    e) Alanine-Aminotransferase (ALAT) > 2x UNL
    f) Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
    7.Prior administration of any biological compound in the last 3 months
    8.Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
    9.Intake of immunosuppressive drugs within the past 30 days (e.g., cyclosporine, tacrolimus)
    10.General exclusion criteria
    a)Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    b)Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    c)Participation in any interventional clinical trial within the last three months
    d)Known intravenous drug abuse
    e)Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
    E.5 End points
    E.5.1Primary end point(s)
    •Treatment emergent adverse events (TEAE) from Day 1 until Day 50 and Day 134,
    • Relationship of TEAEs
    • Serious TEAEs, and relationship of serious TEAEs
    • Number of patients with detection of anti-drug antibodies (pre-/post-dosing).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of TEAEs from Day 1 until Day 50 and Day 134,
    E.5.2Secondary end point(s)
    The secondary objective of this clinical trial is the assessment of pharmacokinetics (PK) and pharmacodynamics (PD) of IFX-1 in patients with moderate to severe HS.
    •The PK is measured by plasma concentration of IFX-1 which is determined several times after administration of IFX-1
    Analysis of plasma concentration of IFX-1 will comprise the following measures:
    • Plasma concentration at each timepoint,
    Parameters will be assessed for each of the nine infusions.
    PD is primarily measured by plasma concentration of free, detectable C5a which is determined several times after administration of IFX-1.
    Plasma concentration of free, detectable C5a will be described by:
    • Plasma concentration of free C5a at each time point
    • Relative and absolute change of plasma concentration of free detectable C5a at each time point compared to baseline (i.e., Day 1)
    A secondary object of the trial is to describe efficacy of IFX-1. Key efficacy endpoints are:
    • Clinical Hidradenitis suppurativa parameters
    - Absolute and percentage change from baseline (i.e., Day 1) in AN count per time point
    • HiSCR
    -HiSCR response per time point
    •HS-PGA
    - Achievement of HS-PGA of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline (i.e., Day 1) at Day 22, 50, 134
    - HS-PGA score per time point
    • VAS pain
    - Achievement of at least a 30% reduction and at least a 10 mm reduction in skin pain (VAS), among patients who had a baseline pain assessment ≥ 30 mm (i.e., assessment at Day 1)
    - VAS pain score per time point and change compared to the VAS pain score at baseline (i.e., Day 1)
    •VAS disease
    - VAS disease score per time point and change compared to the VAS disease score at baseline (i.e., Day 1).
    • DLQI
    - DLQI per time point and change compared to baseline DLQI (i.e., Day 1) over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK , PD - at various timepoints
    Efficacy - various timepoints from baseline to follow up with some specifically on Day 22,50,134.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state12
    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)
    Patients will return to standard of care
    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 Decision2016-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-04
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