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    Summary
    EudraCT Number:2021-004794-31
    Sponsor's Protocol Code Number:KIN-1902-2001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-05-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004794-31
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to Assess the Efficacy and Safety of Namilumab in subjects with lung inflammatory disease
    A.3.2Name or abbreviated title of the trial where available
    Resolve-Lung
    A.4.1Sponsor's protocol code numberKIN-1902-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05314517
    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 SponsorKinevant Sciences GmbH
    B.1.3.4CountrySwitzerland
    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 supportKinevant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKinevant Sciences, Inc.
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address151 W. 42nd Street, 15th Floor
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10036
    B.5.3.4CountryUnited States
    B.5.4Telephone number---
    B.5.5Fax number---
    B.5.6E-mailKinevant.resolve-lung@kinevant.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 nameNamilumab
    D.3.2Product code KIN-1902
    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 INNNAMILUMAB
    D.3.9.1CAS number 1206681-39-1
    D.3.9.2Current sponsor codeKIN-1902 (previously IZN-101, MT203, AMG203)
    D.3.9.4EV Substance CodeSUB189153
    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 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 typeMonoclonal 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
    chronic pulmonary sarcoidosis
    E.1.1.1Medical condition in easily understood language
    lung inflammatory disease
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037430
    E.1.2Term Pulmonary sarcoidosis
    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 effect of namilumab on the need for rescue treatment for
    worsening of sarcoidosis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the effect of namilumab on percent predicted forced vital
    capacity (ppFVC);
    • To evaluate the effect of namilumab on the time to rescue treatment;
    • To evaluate the effect of namilumab on proportion of subjects achieving OCS taper without rescue treatment;
    • To assess the effect of namilumab on respiratory symptoms based on the modified King's Sarcoidosis Questionnaire (mKSQ) Lung domain score;
    • To assess the safety and tolerability of namilumab;
    • To assess the presence of anti-drug antibody (ADA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects age ≥ 18 years.
    2. Able and willing to provide written informed consent, which includes compliance with study requirements, study procedures (including performing acceptable spirometry according to ATS criteria), and restrictions listed in the consent form.
    3. ≥ 6-month history of documented sarcoidosis (must include histological report, from any organ, in the subject's medical records).
    4. Have HRCT scan at screening consistent with pulmonary sarcoidosis of the lung parenchyma by central read.
    Note: An HRCT performed as part of clinical care may be used as the screening HRCT as long as the HRCT is performed within 4 weeks of the Screening Visit and is uploaded and deemed of acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study inclusion, it needs to be obtained again as part of the study inclusion procedures.
    5. ppFVC ≥ 50% and DLCO (hemoglobin corrected value) ≥ 40% predicted at screening.
    6. If receiving prednisone (or equivalent), dose must be ≤ 25 mg, and dose must have been stable for at least 4 weeks prior to screening. In addition, subject must agree to taper their steroids beginning at the time of randomization.
    7. If receiving methotrexate and/or other IST, subject must agree to cessation of their IST therapy at randomization.
    8. Have additional evidence of active pulmonary sarcoidosis as defined by:
    a. Medical Research Council Dyspnea scale > 1 (i.e., Grade 2 or more) at screening; AND
    b. Currently on a treatment regimen for pulmonary sarcoidosis that includes OCS, IST, or the combination of OCS and IST. If not currently being treated with either OCS or IST, subjects can still be eligible if there is documentation in the medical records that they have taken OCS and/or IST in the past 2 years for their pulmonary sarcoidosis and have been unable to tolerate them, treatment was not effective, or they subsequently refused to continue taking these medications; AND
    c. One or more of the following is present:
    i. Screening FDG-PET scan showing pulmonary parenchymal uptake consistent with active pulmonary sarcoidosis AND with pulmonary parenchymal SUVmax ≥ 3 on central read;
    Note: A PET/CT performed as part of clinical care may be used as the screening PET/CT as long as the PET/CT is performed within 4 weeks of the Screening Visit and is uploaded and deemed of acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study inclusion, it needs to be obtained again as part of the study inclusion procedures.
    ii. Documentation in the subject's medical record of worsening sarcoidosis (i.e., a clinically meaningful worsening in pulmonary function parameters (e.g., ≥ 5 percent decline in ppFVC) or clinically relevant worsening of radiographic findings (e.g., HRCT, chest x-ray) in the past 12 months);
    iii. Documentation in the subject's medical record that tapering OCS (≥ 5 mg change) and/or tapering ISTs during the past 12 months resulted in an increase of pulmonary disease symptoms, signs, or activity necessitating maintenance or increase in dose of OCS and/or IST.
    9. Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) for at least 4 weeks
    prior to randomization, throughout the study, and for 18 weeks following the last dose of study drug, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal as defined below:
    a. Non-childbearing potential defined as pre-menopausal female with medical history of total hysterectomy, bilateral oophorectomy (removal of ovaries), bilateral salpingectomy, bilateral tubal ligation, or bilateral hysteroscopic sterilization at least 3 months prior to screening;
    b. Postmenopausal defined as 12 months of spontaneous amenorrhea without an alternative medical cause.
    10. Male subjects must agree to use condoms when having sexual intercourse with female partners of childbearing potential and attest that female partners of childbearing potential will use a highly effective method of contraception as described above for at least 4 weeks prior to randomization/enrollment, throughout the study and for 18 weeks following the last dose of study drug. Male subjects must also agree to not donate sperm from the time of signing consent until 18 weeks following the last dose of study drug.
    11. Body Mass Index (BMI) ≤ 40 kg/m2 at screening
    12. Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization.
    E.4Principal exclusion criteria
    1. Hospitalized for any respiratory illness ≤ 30 days prior to or during screening.
    2. ≥ 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization.
    3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] equation) or requiring chronic renal replacement therapy.
    4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) > 2 × upper limit of normal range (ULN), or serum total bilirubin > 1.5 × ULN.
    Note: Subjects with documented history of Gilbert's syndrome may remain eligible if they have a direct bilirubin ≤ ULN).
    5. Platelet count < 100,000 per mm3.
    6. Hemoglobin ≤ 9.5 g/dL.
    7. Absolute neutrophil count < 1,500 per mm3.
    8. Corrected serum calcium > 3.0 mmol/L (> 12 mg/dL).
    9. History of pulmonary alveolar proteinosis (PAP).
    10. Use of any prohibited immunomodulator agent, immunoglobulin or FcRn inhibitor (approved or investigational) within the 6 months prior to or during screening.
    Note: Allergens for hypersensitivity desensitization or vaccines are not excluded. EVUSHELD administration for COVID-19 prophylaxis is allowed up to within 2 weeks prior to baseline (V2).
    11. Treatment with any Janus kinase (JAK) inhibitor within 3 months prior to or during screening.
    12. Participation in another interventional clinical trial within 6 months prior to or during screening and throughout the duration of participation in this study.
    13. History of left ventricular ejection fraction (LVEF) ≤ 40% or New York Heart Association (NYHA) class III or IV heart failure.
    14. ECG abnormalities that warrant further clinical investigation or management at screening or Fridericia corrected QT interval (QTcF) > 480 msec on the 12-lead ECG at screening; if QTcF exceeds 480 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF measures should be used to determine eligibility.
    Note: If a subject has a pre-existing bundle branch block (BBB), the QTcF exclusion cutoff will be > 500 msec.
    15. Pulmonary hypertension requiring therapy.
    16. Systolic blood pressure (SBP) < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg at screening.
    17. Documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection with pulmonary
    involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization.
    18. Administration of any fully live virus or bacterial vaccinations within 3 months prior to or during screening or administration of non-live or live-attenuated vaccine within 2 weeks of randomization.
    Note: COVID-19 booster and influenza vaccinations are allowed to be completed during the study.
    19. Systemic (oral or parenteral) antibiotic or pulse OCS treatment for any indication within 6 weeks prior to randomization.
    Note: A systemic (oral or parenteral) antibiotic prescribed for infection prophylaxis (i.e., not for treatment of an infection) is allowed as long as it was started at least 6 weeks prior to the Baseline Visit AND is not a prohibited medication per protocol.
    20. Three or more lower-respiratory tract infections requiring antimicrobial therapy within 12 months prior to screening.
    21. Any history of mycetoma or fungal respiratory infection.
    22. Requirement for supplemental oxygen at rest.
    23. History of or planned solid organ or hematopoietic cell transplantation.
    24. Prior or planned pneumonectomy and/or planned lobectomy.
    Note: Lobectomy performed ≥ 12 months prior to randomization is allowed.
    25. Smoking or using any form of inhaled tobacco, inhaled nicotine (including vaping), or inhaled cannabis preparations within 6 months of screening. Subjects are also excluded if they are not likely to refrain from these activities throughout the Study Treatment Period and 18 weeks following the last dose of study drug.
    26. A diagnosis of, or presentation consistent with, Lofgren's syndrome.
    27. Other significant pulmonary disease, or conditions that prevent subject from performing acceptable spirometry.
    28. Autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study.
    29. Symptoms and/or signs of extra-pulmonary sarcoidosis (e.g., cardiac or neurologic sarcoidosis) that require ongoing treatment that would interfere with the protocol-specified treatment regimen or confound the interpretation of the study data (e.g., tapering of IST and/or OCS).
    Note: Subjects who require topical or intra-ocular therapies for skin or ophthalmic sarcoid disease are not excluded.

    Please refer to protocol section 4.2 for detailed exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects requiring rescue treatment for worsening of sarcoidosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    E.5.2Secondary end point(s)
    • Change from baseline in percent predicted forced vital capacity (ppFVC);
    • Time to rescue treatment;
    • Proportion of subjects successfully achieving OCS taper without rescue treatment;
    • Change from baseline in the mKSQ Lung domain score;
    • Safety and tolerability, including assessment of physical examinations (PEs), vital signs, electrocardiograms (ECGs), clinical laboratory measurements, and AEs;
    • Number of subjects positive for ADA to namilumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol Appendix 1 Schedule of Assessments
    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 Yes
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Optional open-label extension (OLE)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Kingdom
    United States
    Belgium
    France
    Germany
    Netherlands
    Türkiye
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 100
    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 Decision2022-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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