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    Summary
    EudraCT Number:2021-000563-69
    Sponsor's Protocol Code Number:IPCT003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-04
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2021-000563-69
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100 in Subjects with Diabetic Foot Ulcers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100 in Subjects with Diabetic Foot Ulcers
    A.4.1Sponsor's protocol code numberIPCT003
    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 SponsorIlya Pharma AB
    B.1.3.4CountrySweden
    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 supportIlya Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIlya Pharma AB
    B.5.2Functional name of contact pointAndreas Fasth
    B.5.3 Address:
    B.5.3.1Street AddressDag Hammarskjölds väg 30
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeSE-752 37
    B.5.3.4CountrySweden
    B.5.4Telephone number0460704663110
    B.5.6E-mailandreas.fasth@ilyapharma.se
    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 nameILP100-DP
    D.3.2Product code ILP100-DP
    D.3.4Pharmaceutical form Concentrate for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmilimogene sigulactibac
    D.3.9.3Other descriptive nameILP100
    D.3.9.4EV Substance CodeSUB266680
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50000000 to 1000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/CAT/57335/2016
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 cutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic foot ulcers a systemic complication in diabetes mellitus type 1 or 2
    E.1.1.1Medical condition in easily understood language
    Diabetic foot ulcers a systemic complication in diabetes mellitus type 1 or 2
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety profile of ILP100 in subjects with diabetic foot ulcers (DFU).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare ILP100-DP and Placebo on:
    - Local tolerability.
    - Effect on wound healing.
    - Effect on incidence and severity of wound infections and use of antibiotic treatment.
    - Effect on subject reported wound-related pain.
    - Assess the long term safety profole of ILP100 in subjects with DFU.
    - Investigate pharmacokenitic / pharmacodynamic characteristic of ILP100 in subject with DFU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent.
    2. Males and females aged ≥18 years.
    3. Diagnosis of diabetes mellitus type 1 or 2.
    4. HbA1c ≤ 86 mmol/mol (≤ 10%) at Screening.
    5. Subjects with at least one first time or recurrent full thickness ulcer (at or below the ankle) which fulfils all of the following criteria at Screening and at the time of Baseline:
    • A non-interdigital wound
    • Accessible for administration of IMP, wound study assessments and procedures and possible to completely cover with the primary and secondary dressing
    • Persistence of the wound for at least 6 weeks at Baseline
    • Assessed by the investigator to be of non-venous etiology
    • Minimum full skin ulcer without undermining.
    • A wound area of 0.8-5.0. cm2 after sharp or mechanical debridement at Screening
    • Subjects with more than one eligible wound will have the largest, hence more clinically significant wound, selected at Screening as the index wound. Other wounds should at least be 3 cm apart and not impact the procedures or assessment of the index wound.
    • During the 2-weeks between start of Run-in Phase and Baseline the wound size must not decrease by more than 30% or increase by more than 25%, which correspond to wound areas of 0.6 – 6.3 cm2, or at Screening expected by the Investigator to have a high probability for wound size changes within this range during this period.

    6. Toe pressure ≥ 20 mm Hg. If toe pressure is not available ankle pressure ≥50 mm Hg, to allow inclusion of subjects with ischemic wounds, while excluding subjects with critical limb ischemia.
    7. Expected to comply with the study procedures, including standard of care according to the protocol during the treatment phase and/or per local practise during assessment phase and long term follow up phase including off-loading.with off-loading and follow up schedule.
    E.4Principal exclusion criteria
    1. Infected index wound with clinical signs of inflammation (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
    2. Confirmed osteomyelitis (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
    3. The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing.
    4. Wound duration longer than 2 years.
    5. Active Charcot deformity of the study foot (i.e., foot is erythematous, warm, edematous, and is actively re-modelling).
    6. Estimated eGFR <30 mL/min/1.73m2, by MDRD calculation
    7. Hemoglobin concentration <100 g/L at Baseline.
    8. Planned or ongoing treatment with corticosteroids to an equivalent dose of prednisolone >10 mg per day or other immunosuppressive therapy, or such treatment within 4 weeks prior to Baseline.
    9. Has any major surgery or hospitalization planned up to Week 26.
    10. Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowed.
    11. Revascularization procedure in the index wound leg planned or undertaken within 8 weeks before Screening, or under investigation
    12. Participation in other clinical studies or having received any investigational treatment within 1 month or at the earliest five time the half-life prior to Screening.
    13. Has any disease conditions, including ulcerative dermatological disorders and vasculitis, or comorbidities which is expected to prevent the subject from participating in the study or confounding the evaluation of the safety profile and effect on wound healing of ILP100.
    14. Pregnant or lactating woman.
    15. Male subjects not willing to use condom to prevent pregnancy and drug exposure of a fertile female partner and refrain from donating sperm from the date of the first dose until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid.

    16. Female subjects of childbearing potential unless they use a contraceptive method with a failure rate of < 1% to prevent pregnancy from the start of the Run-in Phase until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid. Effective contraceptive methods include:
    • oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
    • intrauterine device
    • intrauterine system (for example progestin-releasing coil)
    • vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
    • bilateral tubal occlusion or hysterectomy.
    Female subjects are considered of non-childbearing potential if they are pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months’ amenorrhea.

    17. Inability to provide informed consent, for example due to disorders affecting cognition or communication.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to compare incidence and category of IMP related, treatment procedure related, and total AEs and SAEs during 4, 8, 16 and 26 weeks after initiation of treatment with ILP100 and Placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After subject has signed informed consent form and during participation in study until last follow-up visit.
    E.5.2Secondary end point(s)
    Secondary endpoints are comparison between ILP100-DP and Placebo on:
    • Local tolerability up to Weeks 4, 8, 16 and 26, respectively.
    • Proportion of subjects with a local tolerability parameter Grade ≥ 2 Weeks 4, 8, 16 and 26.

    • Wound area reduction (% of Baseline) at Weeks 4, 8, 16 and 26.
    • Wound healing rate during 4, 8, 16 and 26 weeks.
    • Proportion of subjects with ≥50% and 75% partially healed wounds Weeks 4, 8, 16 and 26.
    • Time to partial (≥50% and 75%) and complete healing up to Week 4, 8, 16 and 26.
    • Wound area Weeks 4, 8, 16 and 26.
    • Proportion of subjects with completely healed wounds Weeks 4, 8, 16 and 26.
    • Proportion of subjects with recurrence of index wound up to Week 26.

    • Proportion of subjects with new wound infections Week 4, 8, 16 and 26.
    • Days on antibiotic treatment up to Week 26.

    • Change in subject-reported wound-related pain compared to Baseline Weeks 4, 8,16 and 26.
    • Compare incidence and category of IMP related, treatment procedure related, and total AEs and SAEs annually Year 1 to 5 after initiation of
    treatment with ILP100 and Placebo.
    • CXCL12 levels in plasma up to Week 16.
    • Presence of viable L. reuteri containing the pSIP_CXCL12 plasmid in wounds up to Year 5. Condition: no further analyses after study treatment has
    been unblinded and the patient has demonstrated two consecutive negative results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After subject has signed informed consent form and during participation in study until week 26.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 concerned2
    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 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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    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)
    None
    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 Decision2021-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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