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    Summary
    EudraCT Number:2015-002180-41
    Sponsor's Protocol Code Number:DSC127-2012-01
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-05
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2015-002180-41
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Aclerastide (DSC127) in Treating Non-healing Foot Ulcers in Subjects with Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study of the safety and efficacy of a potential new treatment for patients suffering from ulcers on their foot as a consequence of their Diabetes Mellitus
    A.4.1Sponsor's protocol code numberDSC127-2012-01
    A.5.4Other Identifiers
    Name:IND Number:113,711
    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 SponsorDerma Sciencs Inc
    B.1.3.4CountryUnited States
    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 supportDermaSciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Foundation eeu
    B.5.2Functional name of contact pointDr Oleg Polnjak
    B.5.3 Address:
    B.5.3.1Street AddressLacpleasa Street 45a
    B.5.3.2Town/ cityLielvarde
    B.5.3.3Post codeLV 5070
    B.5.3.4CountryLatvia
    B.5.6E-mailOleg.Polnjak@crfound-eeu.org
    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 nameAclerastide
    D.3.2Product code DSC127
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 No
    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 placeboGel
    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 - patients with diabetes mellitus who have a chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcer, 0.75 to 6.0 sq cms in size.
    E.1.1.1Medical condition in easily understood language
    Patients who have had a foot ulcer for more thna 1 month and less than one year as a result of their with Diabetes Mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    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
    Clinical Trial to Evaluate the Efficacy and Safety of Aclerastide (DSC127) in Treating Non-healing Foot Ulcers in Subjects with Diabetes Mellitus

    Primary Objective
    The primary objective of the study is to demonstrate the increased incidence of complete wound closure by 10 weeks confirmed two weeks later, by Aclerastide (DSC127) compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements. Complete closure will be confirmed at a study visit 2 weeks later.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    The secondary objective of the study is:
    ● To provide evidence of an acceleration in the time to confirmed complete wound closure (time to event analysis) for the Aclerastide (DSC127) group as compared to vehicle.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject who meets all the following criteria will be included in the study:
    1. Male or female ambulatory subject age ≥18 years at the time of informed consent.
    2. Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL.
    3. At Screening and at Baseline (prior to randomization), subject has at least ulcer that fulfills all of the following criteria:
    a) present for ≥1 month and ≤ 1year.
    b) Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e., Wagner Grade 1 or 2.
    c) Has no sign of infection or osteomyelitis
    d) Plantar neuropathic ulcer - The ulcer must predominately be on the plantar surface (i.e., weight bearing) of the foot to ensure adequate off-loading, and may include the toes but edges of the ulcer may be extended to the sides of the foot.
    e) Size of the target ulcer must be 0.75 - 6 cm.2
    f) Target ulcer must be non-healing as defined as <30% reduction in size in response to Standard of Care during the two-week Screening Period.
    o If more than one ulcer is present that meets the Inclusion Criteria, the largest one meeting all criteria will be considered the target ulcer.
    o If there are two ulcers the same size that meet all criteria the one with the higher Wagner Grade will be considered the target ulcer.
    o If there are two ulcers of the same size and same Wagner Grade, the one present for the longest (qualifying) time will be considered the target ulcer.
    o Non-target ulcers will also be treated according to Standard of Care (Charcot Neuroarthropathy of the foot with the target ulcer must be excluded).
    4. Has an ankle brachial index (ABI) >0.7 on the leg of the foot with the target ulcer.
    5. Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments. A subject will be considered to have site-specific neuropathy sufficient for loss of protective sensation (LOPS) if he/she is unable to feel a 5.07 Semmes-Weinstein monofilament in at least five of the following seven sites on the study foot:
    o Plantar to toes and metatarsals 1, 3, and 5 (three sites).
    o Plantar to midfoot medial and lateral (two sites).
    o Plantar heel (one site).
    o Dorsal distal first interspace (one site).
    6. A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening.
    7. A female subject of childbearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, tubal ligation, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
    8. Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures.
    E.4Principal exclusion criteria
    A subject satisfying any of the following criteria will be excluded from participating in the study:
    1. Has a known hypersensitivity to any of the investigational drug or vehicle components.
    2. Has been exposed to any investigational agent within 30 days of entry into the study.
    3. A female who is pregnant or nursing.
    4. Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
    5. Has a hemoglobin of less than 8.5 gm/dL.
    6. Transaminase levels greater than 3x normal.
    7. Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
    8. Has had prior radiation therapy of any part of the foot with the target ulcer under study.
    9. Use of systemic corticosteroids or immunosuppressants (within the 8 weeks prior to screening).
    10. Has an ulcer primarily ischemic in etiology as diagnosed by an ABI of <0.7 on the affected extremity or great toe systolic pressure <50 mmHg or a transcutaneous oxygen pressure (TcPO2) <40 mmHg in the supine position and <40 mmHg while sitting, measured on the forefoot with electrode set at 44 C on the affected foot.

    11. Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease.

    12. Has received a biologic agent to include growth factors and skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days.

    13. Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening.

    14. Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene.

    15. Has uncontrolled hypertension, in the opinion of the Investigator.

    16. Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.
    E.5 End points
    E.5.1Primary end point(s)
    • The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later) after initiation of investigational product application.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis, the proportion of subjects with confirmed complete wound closure by 12 weeks, will be analyzed using a mixed methods logistic regression model which will include the stratification factors of ulcer size at Baseline, and ulcer grade as well as the covariates of duration of target ulcer and subject age. Study sites (pooled) will be treated as a random effect to account for possible correlation between subjects within a site.
    E.5.2Secondary end point(s)
    Secondary Objectives
    The secondary objective of the study is:
    ● To provide evidence of an acceleration in the time to confirmed complete wound closure (time to event analysis) for the Aclerastide (DSC127) group as compared to vehicle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Time to the visit where the target ulcer achieves confirmed complete wound closure occurs (skin re-epithelialization without drainage or dressing requirements confirmed at a study visit 2 weeks later)
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    South Africa
    Ukraine
    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 years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 422
    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)
    Normal Treatment - if required patient will recieve surgical boots supplied during the study as supportive therapy
    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 Decision2015-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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