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    Summary
    EudraCT Number:2016-000460-42
    Sponsor's Protocol Code Number:AK001-002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2016-05-10
    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 number2016-000460-42
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of the Safety and Efficacy of AK001 in Patients with Nasal Polyps
    A.4.1Sponsor's protocol code numberAK001-002
    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 pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address75 Shoreway Rd, Suite A
    B.5.3.2Town/ citySan Carlos
    B.5.3.3Post codeCA 94070
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505975001
    B.5.6E-mailosiddiqui@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.3.2Product code AK001
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNAK001 drug product (DP)
    D.3.9.2Current sponsor codeAK001 drug product (DP)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe nasal polyposis
    E.1.1.1Medical condition in easily understood language
    Nasal polyps
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10028756
    E.1.2Term Nasal polyps
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 evaluate the effect of 2 different dose levels of AK001 in combination with an intranasal steroid (INS) versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment in Total Polyp Score (TPS)
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of 2 different dose levels of AK001 in combination with an INS versus the INS alone on changes from Baseline to Week 12 after the start of treatment in:
    a) Size of polyps as evaluated by Lund-Mackay score at selected Investigator sites by computed tomography (CT) scan
    b) Nasal airway patency as evaluated by peak nasal inspiratory flow (PNIF)
    c) Ability to smell (University of Pennsylvania Smell Identification Test™ [UPSIT])
    d) Patient-reported symptoms of sinusitis (Sino-nasal Outcome Test-22 [SNOT-22] and Visual Analogue Scales [VASs])
    e) Clinical symptoms improvement scale
    f) Quality of life (36-Item Short Form Health Survey [SF-36])
    2. To evaluate the time to first response in TPS
    3. To evaluate the change in TPS, UPSIT, and patient-reported symptoms of sinusitis over time
    4. To evaluate the safety and tolerability of 2 different dose levels of AK001 in combination with an INS during 7 weeks of study drug in patients with moderate to severe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible for the study if all of the following criteria are met:
    1. Written informed consent
    2. Male and female patients aged ≥18 and ≤75 years at the time of Screening
    3. SNOT-22 ≥30
    4. At Screening, TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
    Polyp grading scale for each nostril:
    0=no nasal polyps
    1=small polyps in the middle meatus not reaching below the inferior border of the middle turbinate
    2=polyps reaching below the lower border of the middle turbinate
    3=large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate
    4=large polyps causing complete obstruction of the inferior nasal cavity
    5. History of at least 2 of the following symptoms for more than 4 weeks prior to Screening:
    a) Anterior nasal discharge
    b) Posterior nasal discharge
    c) Nasal congestion, blockade, or obstruction
    d) Decreased sense of smell
    e) Facial pain or pressure
    6. Received continuous topical nasal steroids and/or leukotriene receptor antagonists for at least 8 weeks prior to Screening unless failure or no effect of prior nasal steroid or leukotriene receptor antagonist therapy is documented
    7. At randomization, received ≥80% of doses of NASONEX scheduled during the Run-in period
    8. At randomization, TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale (see Inclusion Criterion #4) and despite prior INS treatment during the Run-in period
    9. Female patients must be post-menopausal for ≥1 year with documented follicle-stimulating hormone (FSH) >30 IU/L, surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or, if of child-bearing potential, willing to use a highly effective method of contraception from Screening until at least 17 weeks after the last dose of the study drug is administered, which corresponds to approximately 5 half-lives of AK001
    10. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until at least 17 weeks after the last dose of the study drug is administered, which corresponds to approximately 5 half lives of AK001. 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.
    11. Negative Screening ova and parasite test
    12. No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings
    13. Able to comply with all study procedures including recording scores of symptoms (i.e., anterior nasal discharge; posterior nasal discharge, nasal congestion, blockade, or obstruction; decreased sense of smell; facial pain or pressure) at clinic visits
    E.4Principal exclusion criteria
    Patients are ineligible for the study if any of the following criteria are met:
    1. Use of systemic corticosteroids within 6 weeks prior to Screening (or 5 half-lives, whichever is longer) or scheduled to receive systemic corticosteroids
    2. Chronic use of antibiotic therapy within 3 months prior to Screening
    3. Receipt of short-term antibiotic therapy within 14 days prior to Screening or use of antibiotics during the Screening period
    4. Acute infection that requires antibiotic, antiviral, or antifungal therapy within 30 days prior to Screening
    5. Nasal surgery (including polypectomy) within 6 months prior to Screening
    6. Significant mechanical nasal airway obstruction due to septal deviation based on Investigator assessment
    7. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half lives, whichever is longer, prior to Screening
    8. Use of any medications that may interfere with the study, such as immunosuppressive drugs during the 2 weeks before Screening, or expected to require such medications through Day 168
    9. Receipt of any live attenuated vaccines within 30 days or 5 half-lives, whichever is longer, prior to initiation of treatment in the study or expected to receive such a vaccine during the treatment period
    10. Pregnancy or lactation in women
    11. In patients with comorbid asthma, either of the following:
    a) A FEV1 ≤60% at Screening
    b) An asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for >24 hours for treatment of asthma within 30 days prior to Screening
    12. History of human immunodeficiency virus infection (HIV) or other severe immunosuppressive disease or positive HIV test at Screening
    13. Current diagnosis or prior history of allergic fungal sinusitis, cystic fibrosis, ciliary dyskinesia, Wegener’s Granulomatosis, or Churg-Strauss syndrome
    14. Current diagnosis or prior history of any other condition likely to present with non eosinophilic nasal polyps
    15. History of hepatitis or active/chronic liver disease of any genesis or positive serology for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody at Screening
    16. Current diagnosis or history of cancer
    17. A helminthic parasitic infestation, even if treated, within 6 months prior to Screening
    18. History of or suspected history of cytokine release syndrome
    19. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, endocrine, autoimmune, gastrointestinal, hepatic, skeletal, or central nervous system; other conditions that might interfere with the absorption, distribution, metabolism or excretion of AK001 or would place the patient at increased risk (including any condition that would make it unsafe for the patient to fast as required by the study, such as diabetes)
    20. Known hypersensitivity to any constituent of the product
    21. Legally institutionalized
    E.5 End points
    E.5.1Primary end point(s)
    Total Polyp Score (TPS): Change from Baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day -3, Day 21, Day 49, Day 84, Day 112
    E.5.2Secondary end point(s)
    • Size of polyps as evaluated by Lund-Mackay score at selected sites by CT scan
    • Nasal airway patency as evaluated by PNIF
    • UPSIT
    • SNOT-22 (patient-reported symptoms)
    • VASs (patient-reported symptoms)
    • clinical symptoms improvement scale
    • SF-36 (quality of life)
    • Blood eosinophil and basophil absolute counts

    The following specific additional efficacy endpoints will be evaluated in patients with comorbid asthma:
    • TPS by blinded centralized evaluation of endoscopy
    • Pulmonary function (FEV1, FVC, and FEF) assessed using spirometry
    • ACT
    • Use of asthma rescue therapy

    Pharmacokinetic endpoints:
    Blood samples obtained from the arm that is not used for the study drug infusion will be obtained pre-dose on Days 0, 21, and 49 and on Days 14, 84, 112, and 140 for PK analyses.
    Serum concentrations of AK001 will be measured using a validated enzyme-linked immunosorbent assay (ELISA) method.

    Safety endpoints:
    • TEAEs
    • Withdrawals from study due to AEs
    • Vital sign findings
    • Laboratory test (including anti-drug antibody [ADA]) findings
    • Concomitant medication use
    • Physical examination (PE) findings
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Size of polyps as evaluated by Lund-Mackay score by CT scan: Days -3, 84
    • PNIF: Days 0, 21, 84, 112
    • UPSIT: Days 0, 14, 21, 49, 84, 112
    • SNOT-22: Screening, Days 0, 14, 21, 49, 84, 112
    • VASs: Screening, Run-in, Days -3, 0, 14, 21, 49, 84, 112
    • SF-36: Days 0, 21, 49, 84, 112
    • Blood chemistry and hematology and blood eosinophil and basophil absolute counts: Screening, Days -3, 14, 21, 49, 84, 112, 168
    • Urinalysis: Screening, Days -3, 14, 49, 84, 112, 168
    • ADA: Days 0, 112, 168
    • Pulmonary function (FEV1, FVC, FEF) assessed by spirometry: Screening, Days 21, 49
    • ACT: Screening, Days 0, 21, 49, 84, 112
    • Use of asthma rescue therapy: Screening, Run-in, Days -3, 0, 14, 21, 49, 84, 112, 140
    • Pharmakokinetics: Days 0, 14, 21, 49, 84, 112, 168
    • Safety: various timepoints
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Belgium
    Netherlands
    Spain
    Sweden
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 60
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 70
    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 Decision2016-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-06
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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