Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-004794-31
    Sponsor's Protocol Code Number:KIN-1902-2001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-21
    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 ConcernedFrance - ANSM
    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 efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS).
    E.2.2Secondary objectives of the trial
    Key Secondary Objective: To evaluate the effect of namilumab on proportion of subjects on OCS taper without rescue.

    Please refer to protocol section 2.1 for other secondary objectives.
    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 and restrictions listed in the consent form.
    3. ≥6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
    4. Have HRCT and [18F]-FDG PET/CT scans at Screening consistent with active pulmonary sarcoidosis of the lung parenchyma by central read.
    5. ppFVC ≥50% to ≤90% and DLCO ≥50% at Screening.
    6. If receiving prednisone (or equivalent), dose must have been ≤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, dose must have been stable for ≥3 months prior to Screening and subject must agree to cessation of their IST therapy at randomization.
    8. Symptomatic as indicated by modified Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) in the prior 6 months.
    9. Female subjects must agree to use an approved highly effective birth control (BC) method (<1% failure rate per year) for at least 28 days prior to randomization, throughout the study and for 8 weeks (56 days) post last dose of study drug, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal as defined below:
    • 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;
    • Postmenopausal defined as12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age >40 years) a documented serum FSH level must be ≥30 mIU/mL;
    • Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to randomization and throughout the study, and for 8 weeks (56 days) following the last dose of study drug.
    10.Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception as described above and for consistent duration.
    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 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).
    5. Platelet count <100,000 per mm3.
    6. Hemoglobin ≤9.5 g/dL.
    7. Absolute neutrophil count <1,000 per mm3.
    8. Corrected serum calcium >3.5 mmol/L (14 mg/dL).
    9. Positive for anti-GM-CSF autoantibody, or history of pulmonary alveolar proteinosis (PAP).
    10. Use of any biologic immunomodulator agent (approved or investigational) within the 6 months prior to Screening. Allergens for hypersensitivity desensitization or vaccines are not excluded per this criterion. Treatment with immunoglobulin within 6 months prior to Screening. Treatment with any investigational immunomodulator (e.g., Neuropilin 2 (NRP2) modulator) within 6 months prior to Screening.
    11. Treatment with any Janus kinase (JAK) inhibitor within 3 months prior to Screening.
    12. Participation in another interventional clinical trial within 6 months prior to Screening.
    13. History of left ventricular ejection fraction (LVEF) ≤30% 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.
    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. Has documented laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other approved clinical testing ≤3 months prior to randomization.
    18. Administration of any fully live virus or bacterial vaccinations within 3 months prior to Screening or administration of non-live or liveattenuated
    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 42 days prior to randomization.
    20. Three or more lower, respiratory tract infections requiring antimicrobial therapy within 12 months prior to Screening.
    21. 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. Prior use within 12 months of Screening of, or inability to refrain from throughout the study period and 8 weeks (56 days) after last dose of
    study drug, smoking or using any form of inhaled tobacco, inhaled nicotine (including vaping) or inhaled cannabis preparations.
    26. A diagnosis of, or presentation consistent with, Lofgren’s syndrome.
    27. Other significant pulmonary disease likely to interfere with the primary endpoint; the Principal Investigator must discuss any such concerns with the Sponsor or designee prior to randomization.
    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 that are likely to warrant treatment in addition to that required for the subject’s pulmonary disease.
    30. Significant ischemic heart disease, including myocardial infarction within 6 months, unstable angina, or percutaneous transluminal coronary angioplasty (PTCA)/stent within 1 month prior to Screening; or, planned coronary intervention (e.g., coronary artery bypass graft [CABG] or PTCA/stent) during the subject’s participation in this study.
    31. Known or suspected active and untreated/inadequately treated tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may be enrolled if anti-TB therapy is commenced prior to randomization. Subjects with positive serology for HIV, hepatitis B or C must have an undetectable viral load by real-time polymerase chain reaction (RT-PCR) prior to randomization.
    32. Females who are pregnant or breastfeeding or intend to be during the course of the study.
    33. Prior history of any malignancy (not including fully resected squamous and basal cell carcinoma of the skin, fully resected intra-epithelial neoplasia or carcinoma in situ of the cervix) or lymphoproliferative disorder within the past 5 years.

    Please refer to protocol section 4.2 for detailed exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in percent predicted forced vital capacity (ppFVC) at 26 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    E.5.2Secondary end point(s)
    Key secondary endpoint: Proportion of subjects successfully achieving OCS taper without rescue

    Please refer to protocol section 2.2 for other secondary endpoints.

    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 EEA17
    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
    Turkey
    United States
    Belgium
    France
    Germany
    United Kingdom
    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 months3
    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 months3
    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 state20
    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 Decision2022-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 03:05:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA