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    Summary
    EudraCT Number:2021-005037-16
    Sponsor's Protocol Code Number:217095
    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:2022-02-28
    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 number2021-005037-16
    A.3Full title of the trial
    A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of depemokimab (GSK3511294) in patients with chronic rhinosinusitus with nasal polyps (CRSwNP).
    A.4.1Sponsor's protocol code number217095
    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 SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameDepemokimab
    D.3.2Product code GSK3511294
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNDepemokimab
    D.3.9.1CAS number 2243274-14-6
    D.3.9.3Other descriptive nameGSK3511294
    D.3.9.4EV Substance CodeSUB219256
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 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
    Chronic Rhinosinusitis with Nasal Polyps
    E.1.1.1Medical condition in easily understood language
    Chronic Rhinosinusitis with Nasal Polyps
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10080060
    E.1.2Term Chronic rhinosinusitis with 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
    To evaluate the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of depemokimab 100 mg SC + SoC compared to placebo + SoC at Week 52 in terms of symptom scores for rhinorrhoea (runny nose) and loss of smell
    •To evaluate the efficacy of depemokimab 100 mg SC + SoC compared to placebo + SoC at Week 52 in terms of the Lund Mackay CT score
    •To evaluate the impact on quality of life of depemokimab 100 mg SC + SoC compared to placebo + SoC at Week 52 in patients with a diagnosis of CRSwNP
    •To evaluate the efficacy of depemokimab 100 mg SC + SoC compared to placebo + SoC prior to Week 26 in participants with a diagnosis of CRSwNP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply at screening:
    AGE
    1. 18 years of age and older inclusive, at the time of signing the informed consent.
    CRSwNP / ECRS DIAGNOSIS
    2. Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator (see Appendix 10)
    3.Participants who have had at least one of the following at Visit 1:
    • previous nasal surgery for the removal of NP;
    • have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP;
    • medically unsuitable or intolerant to systemic corticosteroid.
    4.Participants (except for those in Japan) must be on daily treatment with INCS (including intranasal liquid steroid wash/douching) for at least the 8 weeks immediately prior to screening.
    5.Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (runny nose) based on clinical assessment by the investigator.
    6.Presence of symptoms of chronic rhinosinusitis as described by at least 2 different symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), plus
    • facial pain/pressure
    and/or
    •reduction or loss of smell
    GENDER
    7.Male or eligible female participants:
    Female Participants:
    • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
    o Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4
    OR
    o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4, from at least 14 days prior to the first dose of study intervention until at least 30 weeks after the last administered dose of study intervention.
    • A WOCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1 and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention. Additional requirements for pregnancy testing are located in the SoA (Section 1.3).
    • Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    INFORMED CONSENT
    8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this study protocol.
    French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    CONCURRENT CONDITIONS/MEDICAL HISTORY
    1.As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
    2.Cystic fibrosis
    3.Antrochoanal polyps
    4.Nasal cavity tumor (malignant or benign)
    5.Fungal rhinosinusitis
    6.Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils
    7.Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of nasal polyp score
    8.Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening
    9.Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
    10.Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening
    11.Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is excepted.
    12.Participants where NP surgery is contraindicated in the opinion of the Investigator
    13.Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) EGPA (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis
    14.Parasitic infection: Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1
    15.Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus – HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma
    16.Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (NOTE:Participants that had localised carcinoma of the skin which was resected for cure will not be excluded).
    17.Liver Disease:
    •Alanine aminotransferase (ALT) >2x ULN
    •Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
    •Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
    NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C) are acceptable if participant otherwise meets entry criteria.
    18.Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
    19.Vasculitis: Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
    20.Hypersensitivity: Participants with allergy/intolerance to the excipients of depemokimab in Section 6.1, a monoclonal antibody, or biologic.
    21.COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active COVID-19 infection must be excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant should remain symptom-free. Reported smell/ taste complications from COVID-19 must be used as exclusion.
    22.Participants that have been exposed to ionising radiation in excess of 10mSv above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies. NOTE: Clinically justified therapeutic or diagnostic exposures are not included in this cumulative calculation.
    PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
    23.Previous participation: Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.
    24.Investigational Medications (Biologics or non-biologics): Participants currently enrolled in another clinical study. OR participants who have received treatment with an investigational drug within the specified washout periods (refer to Section 6.8.2) prior to Visit 1 (this also includes investigational formulations of marketed products).
    PRIOR/CONCOMITANT THERAPY
    25.Monoclonal antibodies targeting IL-5/5R: Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1.
    For more information on exclusion criteria please refer to page no 68-70 from protocol
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    a) Change from baseline in total endoscopic NP score at Week 52 (centrally read)
    Change from baseline in mean nasal obstruction score (verbal response scale [VRS]) from Week 49 through to Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through to Week 52
    E.5.2Secondary end point(s)
    •Change from baseline in mean symptom score for rhinorrhoea (runny nose) (VRS) from Week 49 through to Week 52
    •Change from baseline in mean symptom score for loss of smell (VRS)
    from Week 49 through to Week 52
    •Change from baseline in Lund Mackay CT score at Week 52
    •Change from baseline in SNOT-22 total score at Week 52
    •Change from baseline in mean nasal obstruction score (VRS) from
    Week 21 through to Week 24
    •Change from baseline in total endoscopic NP score at Week 26
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through to Week 52
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Argentina
    Canada
    China
    Japan
    Russian Federation
    United Kingdom
    United States
    Belgium
    France
    Germany
    Netherlands
    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 months10
    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 months10
    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: 240
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 250
    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)
    No post treatment access to study treatment planned. Subjects will remain on SoC throughout the trial and will continue as such after completion of this study.
    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 Decision2022-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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