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    Summary
    EudraCT Number:2021-002967-23
    Sponsor's Protocol Code Number:M-17923-30
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-09-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002967-23
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled
    Phase 3 Clinical Trial to Assess the Efficacy and
    Safety of Lebrikizumab in Combination With Topical
    Corticosteroids in Adult and Adolescent Patients
    With Moderate-To-Severe Atopic Dermatitis That
    Are Not Adequately Controlled With Cyclosporine or
    For Whom Cyclosporine is Not Medically Advisable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lebrikizumab in patients with
    AD not adequately controlled or non-eligible for
    cyclosporine
    A.3.2Name or abbreviated title of the trial where available
    ADvantage
    A.4.1Sponsor's protocol code numberM-17923-30
    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 SponsorAlmirall, S.A.
    B.1.3.4CountrySpain
    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 supportAlmirall, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall, S.A.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRonda General Mitre, 151
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932913545
    B.5.6E-mailgco@almirall.com
    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 nameLebrikizumab
    D.3.2Product code LY3650150
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlebrikizumab
    D.3.9.2Current sponsor codeLY3650150
    D.3.9.3Other descriptive nameLEBRIKIZUMAB
    D.3.9.4EV Substance CodeSUB31913
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    atopic dermatitis
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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
    To evaluate the efficacy of lebrikizumab
    compared with placebo in patients not
    adequately controlled with cyclosporine or for
    whom cyclosporine is not medically advisable
    up to Week 16
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy in patients not
    adequately controlled with cyclosporine or for
    whom cyclosporine is not medically advisable
    between Week 16 up to Week 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults and adolescents (aged ≥12 to <18 years at the time of ICF/IAF and weighing ≥40
    kg)
    2. Chronic AD (according to Hanifin and Rajka Criteria2) that has been present for ≥1 year
    before the Screening visit
    3. EASI score ≥16 at the Baseline Visit
    4. IGA score ≥3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit
    5. ≥10% BSA of AD involvement at the Baseline visit
    6. Documented history by a physician of an inadequate response to existing topical
    medications within 6 months before Screening, defined as: inability to achieve good disease
    control (eg, not able to achieve IGA ≤2) after use of at least a mid-potency TCS for
    at least 4 weeks, or for the maximum duration recommended by the product prescribing
    information (eg, 14 days for high/very-high-potency TCS), whichever is shorter
    7. Documented history by a physician of either:
    a) No previous CsA exposure and not currently a candidate for CsA treatment because of
    i. medical contraindications (eg, uncontrolled hypertension on medication), or
    ii. use of prohibited concomitant medications (eg, statins, digoxin, macrolide
    antibiotics, barbiturates, anti-seizure drugs, nonsteroidal anti-inflammatory
    drugs, diuretics, angiotensin-converting-enzyme inhibitors, St John’s Wort,
    etc.), or
    iii. increased susceptibility to CsA-induced renal damage (elevated creatinine)
    and/or liver damage (elevated function tests results), or
    iv. increased risk of serious infections, or
    v. hypersensitivity to CsA active substance or excipients
    OR:
    b) Previous exposure to CsA; CsA treatment should not be continued or restarted because
    of
    i. intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver
    function test results, uncontrolled hypertension, paraesthesia, headache, nausea,
    hypertrichosis); or
    ii. requirement for CsA at doses or durations beyond those specified in the
    prescribing information or inadequate response
    8. Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4
    of 7 days before randomisation
    9. Willing and able to comply with all clinic visits and study-related procedures and
    questionnaires
    10. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual
    intercourse) or to use a highly effective contraceptive method during the treatment period
    and for at least 18 weeks after the last dose of lebrikizumab or placebo
    11. Male patients must agree to use an effective barrier method of contraception during the
    study and for a minimum of 18 weeks following the last dose of study drug if sexually
    active with a WOCBP
    12. Patient must provide signed ICF. Adolescent patients must also provide separate informed
    assent to enrol in the study and sign and date either a separate IAF or the ICF signed by the
    parent/legal guardian (as appropriate based on local regulations and requirements)
    E.4Principal exclusion criteria
    1. Participation in a prior lebrikizumab clinical study
    2. Treatment with IL-4 or IL-13 antagonists biological therapies before the Baseline visit.
    Exception: previous treatment with dupilumab will be allowed in a subset of patients. A washout of at least 8
    weeks before the Baseline visit will be required for this subpopulation
    3. Treatment with TCS within 1 week before the Baseline visit
    4. Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as
    crisaborole, or cannabinoids within 2 week before the Baseline visit
    5. Treatment with any of the following agents within 4 weeks before the Baseline visit:
    a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,
    cyclosporine, mycophenolate-mofetil, interferon-γ, JAK inhibitors, azathioprine,
    methotrexate, etc.)
    b. Phototherapy and photochemotherapy (PUVA) for AD
    6. Treatment with the following before the Baseline visit:
    a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
    longer;
    b. B cell-depleting biologics, including but not limited to rituximab, within 6 months;
    c. Other biologics within 16 weeks or 5 half-lives (if known) , whichever is longer
    7. Treatment with a live (attenuated) vaccine within 18 weeks of the Baseline visit, planned
    during the study, or 12 weeks after the study treatment is discontinued
    8. History of anaphylaxis as defined by the Sampson criteria40
    9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the
    Screening visit
    10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid
    severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score
    ≥1.5 or a history of ≥2 asthma exacerbations within the last 12 months requiring systemic
    [oral and/or parenteral] corticosteroid treatment or hospitalisation for >24 hours)
    11. Have had any of the following types of infection within 3 months of Screening or develop
    any of these infections before randomisation:
    a. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment);
    b. Opportunistic (as defined in Winthrop et al. 2015). NOTE: Herpes zoster is considered
    active and ongoing until all vesicles are dry and crusted over;
    c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
    d. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring
    cellulitis, chronic osteomyelitis)
    12. Have a current or chronic infection with hepatitis B virus
    13. Have a current infection with hepatitis C virus (ie, positive for hepatitis C RNA)
    14. Have known liver cirrhosis and/or chronic hepatitis of any etiology
    15. Diagnosed active endoparasitic infections or at high risk of these infections
    16. Known or suspected history of immunosuppression, including history of invasive
    opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis,
    pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent,
    recurrent, or prolonged infections, per the Investigator’s judgment
    17. History of HIV infection or positive HIV serology at Screening
    18. In the Investigator’s opinion, any clinically significant laboratory test results from the
    chemistry, haematology, or urinalysis tests obtained at the Screening visit
    19. Presence of skin comorbidities that may interfere with study assessments
    20. History of malignancy, including mycosis fungoides, within 5 years before the Screening
    visit, except completely treated in situ carcinoma of the cervix, completely treated and
    resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of
    recurrence in the past 12 weeks
    21. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect
    the patient’s participation in the study. Any other medical or psychological condition that
    in the opinion of the Investigator may suggest a new and/or insufficiently understood
    disease, may present an unreasonable risk to the study patient because of his/her
    participation in this clinical trial, may make patient’s participation unreliable, or may
    interfere with study assessments
    22. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
    during the study
    23. Have had an important side effect to TCS (eg, intolerance to treatment, hypersensitivity
    reactions, significant skin atrophy, and systemic effects), as assessed by the Investigator or
    treating physician that would prevent further use
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients
    achieving EASI 75 (≥75% reduction from
    Baseline in EASI score) at Week 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    E.5.2Secondary end point(s)
    -Percentage of patients achieving IGA 0/1 and 2-point improvement at Week 16.
    -Percentage of patients achieving a 4- point improvement Pruritus NRS at Week 16.
    - % of patients achieving EASI 90 at Week 16.
    - % patients achieving EASI 75, EASI 90 and EASI 50 (by visit up to Week 16)
    - Change from Baseline BSA by visit up to Week 16
    - Change from Baseline SCORAD by visit up to Week 16
    - Change from Baseline Pruritus NRS by visit up to Week 16
    - Change from Baseline sleep loss by
    visit up to Week 16
    - Change from Baseline POEM by visit up to Week 16
    - Change from Baseline DLQI/CDLQI by visit up to Week 16
    - % patients achieving a 4-point improvement DLQI/CDLQI by visit up
    to Week 16
    - Proportion of TCS-free days from Baseline by visit up to Week 16
    -Time to TCS-free use (days) up to Week 16
    - Change from Baseline Skin Pain NRS by visit up to Week 16
    - % patients achieving a 4-point improvement Skin Pain NRS at Week
    16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    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 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 Yes
    E.8.1.7.1Other trial design description
    2 part of the study - first double-blind, second part open label
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Austria
    France
    Poland
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    United Kingdom
    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
    The “end of trial” is defined as the date when all patients randomised in the trial complete
    follow-up contact (either Treatment Completers or those Prematurely Discontinued), or are lost
    to follow-up and have not been able to be contacted, and will be communicated to Competent
    Authorities and the independent ethics committee (IEC) in due time according to local
    regulations.
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 39
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 39
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 312
    F.1.3Elderly (>=65 years) No
    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 state117
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 312
    F.4.2.2In the whole clinical trial 312
    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)
    Once the last dose of study drug is taken (eg, the last visit at which the patient takes IMP [Week
    52]) and related trial measurements are completed, patients should continue to take their usual
    medications, also allowed during the trial, and may resume other medications that were
    interrupted before trial enrolment as deemed appropriate by the Investigator.
    The study drug is for experimental use only, and there are other therapies available to treat the
    disease.
    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 Decision2021-12-01
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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