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    Summary
    EudraCT Number:2017-002581-51
    Sponsor's Protocol Code Number:AK002-006
    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:2017-09-19
    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 number2017-002581-51
    A.3Full title of the trial
    An Open-Label, Pilot Study to Assess the Efficacy and Safety Of AK002 (Siglec-8) in Patients with Antihistamine-Resistant Chronic Urticaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, open-label study to assess the efficacy and safety of AK002 in patients with chronic urticaria who do not respond to anithistamines

    A.3.2Name or abbreviated title of the trial where available
    CURSIG
    A.4.1Sponsor's protocol code numberAK002-006
    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 organisationCharité - Universitätsmedizin Berlin, Dpt. of Dermatology and Allergy
    B.5.2Functional name of contact pointMarcus Maurer
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.6E-mailmarcus.maurer@charite.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.3.2Product code AK002
    D.3.4Pharmaceutical form 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 INNAK002
    D.3.9.2Current sponsor codeAK002
    D.3.9.3Other descriptive nameAK002
    D.3.9.4EV Substance CodeSUB183724
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Yes
    D.3.11.13.1Other medicinal product typehumanized IgG1 antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with different types of chronic urticaria resistant to standard dose antihistamines
    E.1.1.1Medical condition in easily understood language
    Chronic urticaria is characterized by the occurence of recurrent wheals, pruritus and or angioedema which can affect the whole body.
    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 PT
    E.1.2Classification code 10052568
    E.1.2Term Urticaria chronic
    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
    To assess the efficacy of AK002 on symptoms in subjects with CU (change in urticaria control test [UCT] score).
    E.2.2Secondary objectives of the trial
    The efficacy, safety and pharmacodynamics of AK002 on urticaria symptoms, QoL, provocation testing, and histological criteria.

    Extended dosing: To evaluate the long-term safety and tolerability of up to 12 additional doses of AK002 in subjects with CU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adults (≥ 18 and ≤ 85 years old)
    2) Body weight <125 Kg
    3) Informed consent signed and dated
    4) Able to read, understand, and willing to sign the informed consent form and comply with study procedures
    5) Diagnosis of CU for at least 3 months, refractory to antihistamine treatment in single or 4-fold dosage
    6) Willing, committed, and able to return for all clinic visits and complete all study-related procedures, including willingness to have IV infusion of study drug administered by a qualified person
    7) Females of childbearing potential must have a negative pregnancy test at Baseline. Female subjects must be willing to use highly effective contraception (Pearl- 4 Index <1) 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. A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH >40 mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
    Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception 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.
    8) No participation in other clinical trials 4 weeks before participation in this study
    9) Uncontrolled CU (UCT <12) at the time of enrollment
    10) For extended dosing, subjects must have a baseline (Day 1) UCT of ≤5 and a week 22 (Day 155) UCT of ≥ 12 (Complete Response). They must have a UCT of ≤5 post-week 22 (Day 155) and by week 44 (Day 309) i.e., within 6 months from last dose
    E.4Principal exclusion criteria
    1) Acute urticaria
    2) Concurrent/ongoing treatment with immunosuppressives (e.g.,
    cyclosporine, methotrexate, dapsone, or others) within 4 weeks or
    5 half-lives prior to Baseline, whichever is longer
    3) Significant medical condition rendering the patient
    immunocompromised or not suitable for a clinical trial
    4) Significant concomitant illness that would adversely affect the
    subject’s participation or evaluation in this study
    5) History of malignancies within five years prior to screening other
    than a successfully treated non-metastatic cutaneous, basal, or
    squamous cell carcinoma and/or in situ cancer
    6) Presence of clinically significant laboratory abnormalities
    7) Lactating women or pregnant women
    8) Substance abuse (drug or alcohol) or any other factor (e.g., serious
    psychiatric condition) within the last 5 years that could limit the
    subject’s ability to comply with study procedures
    9) Subjects who are detained officially or legally to an official
    institute or those that have been committed to an institution by
    virtue of an order issued either by the judicial or the administrative
    authorities will be excluded from the study
    10) Use of omalizumab within the last 2 months
    11) Receipt of intravenous IgG therapy 30 days prior to Baseline
    12) Plasmapheresis 30 days prior to Baseline
    13) Use (daily or every other day) of Doxepin 14 days prior to Baseline
    14) Receipt of inactive vaccination or live attenuated vaccine 30 days
    prior to Baseline
    15) Use of H2 antihistamines 7 days before Baseline
    16) Intake of leukotriene antagonists within 7 days prior to enrollment
    17) Intake of systemic corticosteroids (e.g., oral or depot) within 14
    days prior to enrollment
    18) Positive screening for ova and parasite test at Baseline
    19) Treatment of helminthic parasite within 6 months of screening
    20) Positive HIV serology at screening
    21) Positive Hepatitis serology at baseline, except for vaccinated
    patients or patients with past but resolved hepatitis at screening
    22) Donation or loss of >500ml of blood within 56 days prior to
    administration of study drug or donation of plasma within 7 days
    prior to administration of drug
    23) Known hypersensitivity to any ingredients of AK002 or drugs
    related to AK002 (e.g., monoclonal antibodies, polyclonal gamma
    globulin)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in Urticaria Control Test (UCT), a score for symptom control in chronic urticaria, from Day 1 (baseline) to Week 22 in CU subjects after treatment with AK002. At Baseline, a 4-week recall will be recorded, prior to first study drug administration. A change of the UCT score of 3 or more points is regarded as clinically relevant (minimal clinically important difference [MCID]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The total study duration for each patient will be approximately 32 weeks. This includes:
    • A screening period of 4 weeks prior to study drug administration
    • Administration of study drug at Day 1, Day 29, Day 57, Day 85, Day 113, Day 141.
    • Follow-up through Day 197 (8 weeks post last dose).
    E.5.2Secondary end point(s)
    1) Safety of subjects treated with AK002: This includes physical examination, routine safety laboratory assessments, vital signs, electrocardiogram (ECG), urine safety, and adverse event reporting (Visits 2–10)
    2) Change in disease activity as assessed by UAS7 and/or CholUAS7 (from Baseline to Visits 3, 5, 8, and 10)
    3) Change in number of symptom-free days per week (patient diary based CSU score; wheals, flares, itch, avoidance behavior) from Baseline to Visits 3, 5, 8, and 10
    4) Change in quality-of-life scores assessed by DLQI, CU-Q2oL, AE-QoL, SD-QoL and CholU-QoL from Baseline to Visits 3, 5, 8, and 10
    5) Change in number of intake of rescue medication from Baseline to Visits 3, 5, 8, and 10
    6) In case of angioedema, change in occurrence of angioedema from Visit 2 to Visit 3, 5, 8, and 10, as assessed by AAS
    7) Change in number of hives and itch severity (from UAS7/CholuAS7) from Baseline to Visits 3, 5, 8, and 10
    8) Change in physician and patient global assessment from Baseline (Day 1) to Visits 3, 5, 8, and 10
    9) Changes in trigger threshold from Baseline (Day 1) to Visits 2, 3, 5, 8, and 10, as assessed by Pulse Controlled Ergometry Test (PCE) and FricTest®, as applicable
    10) Rates of complete response, partial response, and non-response based on UCT, UAS7/CholUAS7, trigger thresholds (where applicable), and QoL from Baseline to Visits 3, 5, 8, and 10
    11) Serum levels at baseline (Day 1) and change from Baseline to Visits 3, 5, 8, and 10 of serum levels of potential biomarkers in AK002-treated subjects (e.g., tryptase, eosinophils, total IgE, basophils, eosinophil cationic protein)
    12) Rates of AK002-treated subjects with relapse, rebound, sustained treatment effects at Visit 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    included in secondary endpoints
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 EEA2
    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
    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 years2
    E.8.9.1In the Member State concerned months5
    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 months5
    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: 40
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 48
    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 of condition
    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 Decision2018-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-06
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