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    Summary
    EudraCT Number:2017-004501-40
    Sponsor's Protocol Code Number:IFX-1-P2.4
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-004501-40
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moderate to severe hidradenitis suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of a monoclonal antibody to treat patients with moderate to severe hidradenitis suppurativa (HS).
    A.4.1Sponsor's protocol code numberIFX-1-P2.4
    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+493641508 180
    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.3.8INN - Proposed INNnot yet available
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis suppurativa (HS)
    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 20.0
    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
    Evaluate a dose-response signal of IFX-1 in subjects with moderate to severe hidradenitis suppurativa according to the Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of IFX-1 using additional outcome measures
    • To assess the safety and tolerability of IFX-1
    • To generate data for pharmacokinetics (PK) and pharmacodynamics (PD) modelling
    • To assess patient-reported outcomes
    • To evaluate the long-term efficacy and safety of IFX-1
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A Pharmacokinetics (PK) substudy will be conducted in approximately 50 of the 175 subjects participating in the Main Period. The subjects in Cohorts 1 to 5 will be sequentially included for participation in the PK substudy if consent for participation was given. The PK substudy assessments will be made on 2 visits during the Main Period, at Weeks 2 and 16.
    E.3Principal inclusion criteria
    1. Male or female, ≥ 18 years of age
    2. Written informed consent obtained from subject
    3. Diagnosis of Hidradentis Suppurativa (HS) for at least 1 year
    4. Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of which must be at least Hurley Stage II or Stage III
    5. Stable HS for at least 2 months before Screening, as determined by the investigator through subject interview and review of medical history
    6. Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics
    7. Total abscess and inflammatory nodule count of ≥ 3
    E.4Principal exclusion criteria
    1. Body weight < 60 or > 130 kg
    2. Any other skin disease that may interfere with assessment of HS
    3. More than 20 draining fistulas
    4. Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening
    5. Prior treatment with IFX-1
    6. Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline only) who have not been on a stable dose during the 28 days before Screening
    7. Subject received systemic non-biologic therapy for HS with potential therapeutic impact for HS during the 28 days before Screening (other than permitted oral antibiotics)
    8. Prior treatment with any of the following medications during the 28 days before Screening:
    a. Any other systemic therapy for HS
    b. Any iv anti-infective therapy
    c. Phototherapy (UVB or psoralen and UVA)
    9. Prior treatment with any of the following medications during the 14 days before Screening:
    a. Analgesics (including opioids) for HS related pain
    b. Prescription-only topical therapies for HS
    c. Oral anti-infectives for infections other than HS
    10. History of moderate to severe heart failure (New York Heart Association Class III or IV), cerebrovascular accident during the 24 weeks before Screening, history of malignancy except for successfully treated non-metastatic basal cell or squamous cell carcinoma or in situ carcinoma of the cervix
    11. One of the following abnormal laboratory findings:
    a. White blood cell count (WBC) < 2500/mm3
    b. Neutrophil count < 1000/mm3
    c. Serum creatinine > 3 × UNL
    d. Total bilirubin > 3 × UNL
    e. Alanine aminotransferase > 5 × UNL
    f. Aspartate aminotransferase > 5 × UNL
    g. Positive Screening test for HIV-1 or 2, or hepatitis B or C virus
    12. Chronic and/or recurring systemic infections, history of invasive infections with atypical pathogens (i.e., which normally do not cause invasive infection, such as listeriosis), or known primary immunodeficiency
    13. Subject is judged to be in poor general health, as determined by the investigator based upon medical history, physical examination, laboratory safety and, a 12 lead ECG
    14. Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant, or depot contraceptive injection in combination with a second method of contraception such as condom, cervical cap, or diaphragm with spermicide during the study and for at least 1 month after last administration of IMP
    15. History of drug or alcohol abuse during the 24 weeks before Screening
    16. Pregnancy, as verified by a positive pregnancy test, or nursing woman
    17. Evidence or suspicion that the subject might not comply with the requirements of the study protocol
    18. Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study
    19. The subject is an employee or direct relative of an employee at the study site or sponsor
    20. The subject is imprisoned or lawfully kept in an institution
    21. The subject has participated in a clinical study during the 3 months before Screening, or plans to participate in a clinical study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects with a response on the basis of the HiSCR determined at Week 16, before administration of IMP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 (before administration of the IMP)
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    1. Percentage of subjects with a response on the basis of the HiSCR determined at Week 12, before administration of IMP
    2. Number of subjects with flares analyzed in terms of ≥ 25% increase in AN count among subjects with a minimum increase of 2 in AN count relative to Day 1
    3. Absolute values and absolute and relative change in modified Sartorius Score (mSS) from Day 1 by time point
    4. Absolute value and absolute and relative change in Patient’s Global Assessment of Skin Pain (Numeric Rating Scale [NRS]) from Day 1 by time point
    5. Percentage of subjects achieving, by time point:
    - At least a 30% reduction and at least 1 unit reduction from Day 1 among subjects with baseline NRS ≥ 3 in Patient’s Global Assessment of Skin Pain (NRS30)
    - At least a 50% reduction and at least 2 units reduction from Day 1 among subjects with baseline NRS ≥ 3 in Patient’s Global Assessment of Skin Pain (NRS50)
    6. Absolute values and absolute and relative change in Dermatology Life Quality Index (DLQI) score from Day 1 by time point

    Safety endpoints:
    7. The number and percentage of subjects who had a treatment-emergent adverse event (TEAE) as well as the number of TEAEs will be assessed for all TEAEs and serious adverse events (SAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12 (before administration of the IMP)
    2. and 3. At weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44 for all patients, and in addition for HiSCR non-responders: at weeks 22, 26, 30, 34, 38
    4. and 5. Daily from Day 0 to week 44
    6. At weeks 16, 32, 44
    7. Continuously from screening to end of study (week 44)
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Bulgaria
    Canada
    Denmark
    France
    Germany
    Greece
    Netherlands
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    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: 167
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 175
    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 Decision2018-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-14
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