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    Summary
    EudraCT Number:2021-002795-39
    Sponsor's Protocol Code Number:CQUC398A12201
    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:2022-09-02
    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 number2021-002795-39
    A.3Full title of the trial
    A randomized, two-arm, placebo-controlled, participant, investigator and sponsor-blinded, proof-of-concept study investigating the efficacy, safety and tolerability of QUC398 in patients with symptomatic knee osteoarthritis
    Etude de preuve de concept randomisée, à deux bras, contrôlée par placebo, en aveugle, évaluant l'efficacité, la sécurité d'emploi et la tolérance du QUC398 chez des patients atteints de gonarthrose symptomatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A proof of concept study to examine QUC398 in participants with knee OA.
    Une étude de preuve de concept pour examiner QUC398 chez les participants avec de gonarthrose.
    A.4.1Sponsor's protocol code numberCQUC398A12201
    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 SponsorNovartis Pharma AG
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S.
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.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 QUC398
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeQUC398
    D.3.9.3Other descriptive nameQUC398
    D.3.9.4EV Substance CodeSUB237721
    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 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
    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
    Knee osteoarthritis
    Gonarthrose
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis
    Arthrose du genou
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 efficacy of QUC398 vs placebo in relieving OA pain in the target knee
    Évaluer l'efficacité de QUC398 par rapport à un placebo pour soulager la douleur liée à l'arthrose dans le genou cible
    E.2.2Secondary objectives of the trial
    •To assess the efficacy of QUC398 vs placebo in preservation of cartilage in the medial compartment of the target knee
    •To assess the efficacy of QUC398 vs placebo in relieving OA pain in the target knee over time
    •To assess the efficacy of QUC398 vs placebo in relieving clinical symptoms and improving function in the target knee over time
    •To assess the safety and tolerability of QUC398 vs placebo.
    • Pour évaluer l'efficacité de QUC398 par rapport au placebo dans la préservation du cartilage dans le compartiment médial du genou cible
    • Évaluer l'efficacité de QUC398 par rapport à un placebo pour soulager la douleur liée à l'arthrose dans le genou cible au fil du temps
    • Évaluer l'efficacité de QUC398 par rapport au placebo pour soulager les symptômes cliniques et améliorer la fonction du genou cible au fil du temps
    • Pour évaluer l'innocuité et la tolérabilité de QUC398 par rapport au placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Weight ≥ 50 kg and a body mass index (BMI) between 18 -35 kg/m2, at Screening 1
    •Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
    •Radiographic medial joint space width (mJSW) of 2 to 4 mm in men or 1.5 to 3.5 mm in women measured at the X=0.225 fixed point location within the medial tibio-femoral compartment of the target knee at Screening 1
    •Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant's judgement
    •Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and 2.
    •Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by:
    - Completed pain diary for at least 6 of the last 7 days prior to Screening 3 AND
    - Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
    • KOOS pain subscale ≤ 60 in the target knee at Screening 1, Screening 2, and Screening 3.

    Additional protocol specified criteria may apply.
    • Poids ≥ 50 kg et indice de masse corporelle (IMC) compris entre 18 et 35 kg/m2, au dépistage 1
    • Grade Kellgren-Lawrence 2 à 4 dans le compartiment tibio-fémoral du genou cible confirmé par radiographie en position de flexion fixe en appui debout et vue postéro-antérieure, au dépistage 1
    • Largeur radiographique de l'espace articulaire médial (mJSW) de 2 à 4 mm chez les hommes ou de 1,5 à 3,5 mm chez les femmes, mesurée à l'emplacement du point fixe X = 0,225 dans le compartiment tibio-fémoral médial du genou cible au dépistage 1
    • OA symptomatique avec douleur modérée à sévère (correspondant à la douleur NRS ≥ 5 à ≤ 9) dans le genou cible pendant la majorité des jours au cours des 3 derniers mois précédant le dépistage 1, selon le jugement du participant
    • OA symptomatique avec douleur modérée à sévère (correspondant à Douleur NRS ≥ 5 à ≤ 9) dans le genou cible lors des dépistages 1 et 2.
    • Douleur arthrosique modérée à sévère (correspondant à Pain NRS ≥5 à ≤9) dans le genou cible au cours des 7 derniers jours précédant le dépistage 3, confirmée par :
    - Journal de la douleur rempli pendant au moins 6 des 7 derniers jours avant le dépistage 3 ET
    - Le journal a signalé une douleur NRS ≥ 5 à ≤ 9 pendant au moins 6 des 7 derniers jours avant le dépistage 3
    • Sous-échelle de douleur KOOS ≤ 60 dans le genou cible lors du dépistage 1, du dépistage 2 et du dépistage 3.

    Des critères supplémentaires spécifiés dans le protocole peuvent s'appliquer.
    E.4Principal exclusion criteria
    •Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient.
    •Symptomatic, patello-femoral pain in the target knee as per investigator's examination at Screening 1.
    •Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1.
    •Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI.
    •Previous exposure to any ADAMTS-5 drug, including QUC398.
    •History or current diagnosis of ECG abnormalities.

    Additional protocol specified criteria may apply.
    • Coxarthrose ipsilatérale douloureuse définie comme une douleur NRS ≥ 3 la majorité des jours au cours des 3 derniers mois précédant le dépistage 1, telle que rapportée par le patient.
    • Douleur fémoro-patellaire symptomatique dans le genou cible selon l'examen de l'investigateur lors du dépistage 1.
    • Désalignement grave > 7,5 ° dans le genou cible (soit en varus, soit en valgus), mesuré à l'aide d'une radiographie standardisée du genou lors du dépistage 1.
    •Patient incapable ou refusant de subir une IRM ou présentant des contre-indications absolues à l'IRM.
    •Exposition antérieure à tout médicament ADAMTS-5, y compris QUC398.
    • Antécédents ou diagnostic actuel d'anomalies ECG.

    Des critères supplémentaires spécifiés dans le protocole peuvent s'appliquer.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12
    Changement par rapport aux valeurs initiales de la sous-échelle de la douleur du score KOOS (Knee Injury and Osteoarthritis Outcome Score) à la semaine 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semaine 12
    E.5.2Secondary end point(s)
    •Change from baseline in cartilage volume of the knee index region at Week 52, as determined from the automated segmentation of 3D-MRI scans
    •Change from baseline in KOOS Pain subscale at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    •Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS) at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    •Change from baseline in total KOOS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    •Change from baseline in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    •Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    •Systemic and local Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Electrocardiogram parameters (ECGs), Vital signs, Laboratory tests
    • Changement par rapport au niveau de référence du volume du cartilage de la région de l'index du genou à la semaine 52, tel que déterminé à partir de la segmentation automatisée des analyses 3D-IRM
    • Changement par rapport au départ dans la sous-échelle de la douleur KOOS aux semaines 1 (jour 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 et 52
    • Modification de la douleur par rapport au départ évaluée par une échelle d'évaluation numérique de la douleur (NRS) aux semaines 1 (jour 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 et 52
    • Changement par rapport au niveau de référence du KOOS total aux semaines 1 (jour 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 et 52
    • Changement par rapport au départ dans les sous-échelles KOOS : autres symptômes, fonction dans la vie quotidienne, fonction dans les sports et les loisirs et qualité de vie liée au genou aux semaines 1 (jour 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 et 52
    • Changement par rapport au départ dans l'évaluation globale du patient (PGA) telle qu'évaluée par le NRS aux semaines 1 (jour 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 et 52
    • Événements indésirables systémiques et locaux liés au traitement (TEAE) et TEAE graves, paramètres d'électrocardiogramme (ECG), signes vitaux, tests de laboratoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified in the secondary endpoints
    Tel que spécifié dans les critères d'évaluation secondaires
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Australia
    New Zealand
    United States
    France
    Spain
    Denmark
    Norway
    E.8.7Trial has a data monitoring committee No
    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
    Study completion is defined as when the last participant finishes their End of study (EOS) visit.
    L'achèvement de l'étude est défini comme le moment où le dernier participant termine sa visite de fin d'étude (FDE)
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 18
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 98
    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 further study treatment will be made available to the participants after study completion. There are approved standard of care medicinal products for the target indication.
    Aucun autre traitement de l'étude ne sera mis à la disposition des participants après la fin de l'étude. Il existe des médicaments standard de soins approuvés pour l'indication cible.
    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 Decision2022-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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