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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001625-79
    Sponsor's Protocol Code Number:AK002-018
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2022-001625-79
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments
    Eine randomisierte, doppelblinde, placebokontrollierte Phase 2-Studie zur Beurteilung der Wirksamkeit und Sicherheit von subkutanem Lirentelimab bei Erwachsenen mit mittelschwerer bis schwerer, durch topische Behandlung unzureichend kontrollierter, atopischer Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
    A.4.1Sponsor's protocol code numberAK002-018
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05155085
    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 SponsorAllakos 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 supportAllakos Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllakos Inc.
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address825 Industrial Road, Suite 500
    B.5.3.2Town/ citySan Carlos
    B.5.3.3Post codeCA 94070
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650597-5002
    B.5.6E-mailinfo@allakos.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 namelirentelimab
    D.3.2Product code AK002
    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 INNLirentelimab
    D.3.9.1CAS number 2283348-97-8
    D.3.9.2Current sponsor codeAK002
    D.3.9.4EV Substance CodeSUB203743
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody
    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
    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 Eczema
    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 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy Objectives:
    The primary objective of the study will be to characterize the efficacy of lirentelimab SC in adult subjects with Atopic Dermatitis (AD) as assessed by the difference in the proportion of subjects who achieve Eczema Area and Severity Index-75 (EASI-75) at Week 14.

    Safety Objectives:
    To evaluate the safety and tolerability of lirentelimab SC in subjects with AD by determining Adverse Event (AE) incidence and severity, study withdrawals due to AE, changes in vital signs and laboratory tests including immunogenicity, changes in concomitant medication use due to AE, and other safety parameters.
    E.2.2Secondary objectives of the trial
    To further characterize the efficacy of lirentelimab SC in adult subjects with AD as measured by the following:
    • % Change in Eczema Area and Severity Index (EASI) from baseline to Week 14.
    • Proportion of subjects with Investigator Global Assessment (IGA) of 0 or 1 and a 2-point improvement at Week 14 vs baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible for the study if all of the following criteria are met:

    1) Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
    2) Male or female aged ≥18 and ≤80 years at the time of signing the ICF.
    3) Chronic AD (as defined by the American Academy of Dermatology Consensus Criteria) (Eichenfield, 2014); that has been present for at least 3 years before screening visit.
    4) Documented recent history of inadequate response to treatment with topical medications such as topical corticosteroids, calcineurin inhibitors, JAK inhibitors, or PDE4 inhibitors (crisaborole) for at least 4 weeks in the 6 months prior to screening, or subjects for whom these topical treatments are otherwise medically inadvisable (e.g., because of side effects or safety risks).
    5) Subjects who are biologic-naïve or biologic-exposed. Biologic-exposed includes subjects who have demonstrated secondary loss of response, intolerance, or lack of access to biologics due to economic reasons.
    6) EASI score of ≥16 at screening and at baseline.
    7) Involvement of at least 10% or more of BSA at screening and at baseline.
    8) An IGA score of 3 or above on a scale from 0–4 at screening and at baseline.
    9) The subject should have applied a stable dose of non-medicated, non-prescription, topical emollient at least twice daily for 7 consecutive days immediately before the baseline visit.
    10) Willing to apply a stable dose of non-medicated, non-prescription, topical emollient, as recommended by the Investigator at least twice daily for the duration of the study, if not already on an emollient at the time of screening.
    11) Commitment to remain on the same dose(s) of AD medication(s), including topical emollients, for the entire duration of study participation unless dose modification is due to unforeseen medical necessity.
    12) Willing and able to comply with the study procedures and visit schedule including follow-up visits.
    13) Female subjects must be either postmenopausal (defined as no menses for 12 months without an alternative medical cause) with FSH level >30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use a highly effective method of contraception as defined in this protocol or abstain from sexual activity, if compliant with preferred and usual lifestyle of the subject, from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer.
    In the case of a postmenopausal female subject with FSH level ≤30 mIU/mL at screening, the subject will be required to have a negative serum pregnancy test during the screening period and will also be required to have a negative urine dipstick pregnancy test prior to dosing and at each study visit.
    14) Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception as defined in this protocol or abstain from sexual activity from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:

    1) Current use of biologics for any indication.
    2) Demonstrated lack of primary response to treatment with a biologic for the treatment of AD defined as no response to treatment despite complete adherence to the prescribed regimen for at least 3 months (primary non-responders).
    3) Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment:
    - Phototherapy for AD
    - Immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), eosinophil-depleting drugs (e.g., pramipexole), and systemic corticosteroids
    - Oral JAK inhibitors within 8 weeks of the baseline visit (requires discussion with Allakos Medical Monitor prior to subject enrolling in study)
    4) Treatment with biologics:
    - Any cell-depleting agents including but not limited to rituximab; within 6 months prior to the baseline visit, or until lymphocyte count returns to normal, whichever is longer
    - TNF inhibitors (e.g., infliximab, adalimumab) and other biologics (e.g., dupilumab, omalizumab, etc.) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer
    5) Any use of topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors (e.g., ruxolitinib), or topical PDE4 inhibitors (crisaborole) for the treatment of AD within 1 week prior to the baseline visit.
    6) Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
    7) Treatment with chemotherapy or radiotherapy in the preceding 6 months.
    8) Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results.
    9) Planned or anticipated use of any prohibited medication.
    10) History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer, or non melanoma skin cancers.
    11) Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk.
    12) A helminth parasitic infection diagnosed within 6 months prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard-of-care therapy.
    13) Evidence of active hepatitis B or C at screening based on serology.
    14) Evidence of active HIV infection at screening based on serology.
    15) Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
    16) Presence of an abnormal screening laboratory value considered to be clinically significant by the Investigator.
    17) Known or suspected history of alcohol, drug, or other substance abuse or dependence that in the opinion of the Investigator may interfere with study participation or assessments.
    18) Prior exposure to lirentelimab or known hypersensitivity to any constituent of the study drug.
    19) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).
    20) Subjects who weigh <40 kg at screening.
    21) Any other reason that in the opinion of the Investigator or the Medical Monitor makes the subject unsuitable for enrollment.
    22) Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration.
    Note: This exclusion criterion does not apply to all types and formulations of vaccines (including live attenuated vaccines) currently authorized/approved by FDA or other regulatory authority for the prevention of COVID-19, which may be administered before, during, or after the study.
    The vaccine should not be administered within 3 days before and within 3 days after the administration of lirentelimab so that any side effects caused by either of the 2 medications can be more easily determined.
    23) Employees or relatives of the Sponsor or the Investigator, or other persons dependent on the Sponsor or the Investigator.
    24) Commitment to an institution by order issued either by the judicial or the administrative authorities.
    25) Presence of a SARS-CoV-2 infection and/or have not completed an authorized/approved COVID-19 primary immunization series as per national recommendations at the time of screening. (Germany only)
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: The primary efficacy endpoint in the study will be proportion of subjects who achieve EASI-75 at Week 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at Week 14, i.e., 2 weeks following the last dose in the double-blind period of the study.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • % Change in EASI from baseline to Week 14.
    • Proportion of subjects with IGA of 0 or 1 and a 2-point improvement at Week 14 compared with baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be assessed at Week 14, i.e., 2 weeks following the last dose in the double-blind period of the study.
    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 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 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 concerned15
    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 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
    United States
    Germany
    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
    The end of the double-blind, placebo-controlled period of the study is defined as the completion of the last follow-up visit of the last enrolled subject who elects not to participate in the open-label extension period of the study.

    For subjects electing to enter the open-label extension period of the study, the end of the open-label extension period of the study is defined as the completion of the last follow-up visit for the last subject.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 110
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 130
    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 Decision2022-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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