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    Summary
    EudraCT Number:2020-000822-24
    Sponsor's Protocol Code Number:VP-C21-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-000822-24
    A.3Full title of the trial
    A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the safety, effectiveness and fate of study drug C21 in people with chronic scarring lung disease characterised by a progressive and irreversible decline in lung function.
    A.3.2Name or abbreviated title of the trial where available
    C21 in IPF
    A.4.1Sponsor's protocol code numberVP-C21-005
    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 SponsorVicore Pharma AB
    B.1.3.4CountrySweden
    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 supportVicore Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVicore Pharma AB
    B.5.2Functional name of contact pointMimi Flensburg
    B.5.3 Address:
    B.5.3.1Street AddressKronhusgatan 11
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post codeSE-411 05
    B.5.3.4CountrySweden
    B.5.4Telephone number+4522109950
    B.5.6E-mailmimi.flensburg@vicorepharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1692
    D.3 Description of the IMP
    D.3.1Product nameC21
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNC21
    D.3.9.2Current sponsor codeC21
    D.3.9.3Other descriptive name3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis
    E.1.1.1Medical condition in easily understood language
    Lung condition which scars the lungs and reduces breathing efficiency
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety of C21 with 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF.
    E.2.2Secondary objectives of the trial
    To evaluate:
    •The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 24 weeks
    •The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 36 weeks
    •The pharmacokinetic (PK) profile of C21 200 mg daily dose (100 mg b.i.d.) after multiple dosing

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent obtained before the initiation of any trial related procedure
    2) A diagnosis of IPF within 3 years prior to Visit 1
    3) Age ≥40 years
    4) FVC ≥80% predicted at Visit 1
    5) FEV1/FVC ratio >0.7 prebronchodilator at Visit 1
    6) Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
    7) Diffuse capacity for carbon monoxide (DLCO) >30% of predicted normal corrected for haemoglobin at Visit 1
    8) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating:
    a. A pattern consistent with usual interstitial pneumonitis (UIP)
    b. Extent of fibrosis > extent of emphysema

    E.4Principal exclusion criteria
    1)Previous and concomitant use of nintedanib or pirfenidone
    2)Smoking (including e-cigarettes) within 6 months prior to Visit 1
    3)Body mass index (BMI) >35 or <18
    4)IPF exacerbation within 3 months prior to Visit 1, as defined by Collard et al. (2016):
    •Acute worsening or development of dyspnoea typically <1 month duration
    •Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier “new” can be dropped)
    •Deterioration not fully explained by cardiac failure or fluid overload
    5)Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery) which in the opinion of the investigator makes the subject inappropriate for this trial
    6)Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
    7)Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
    •Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John’s Wort)
    •CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
    •Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
    •Experimental drugs
    •Any systemic immunosuppressive therapies other than:
    oInhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable
    oCorticosteroids for the treatment of acute exacerbations
    oThe continuation of stable doses of <15 mg daily doses of prednisolone
    8)Treatment with any of the medications listed below within 2 weeks prior to Visit 1:
    oProton pump inhibitors (PPI’s) more than once daily
    oHistamine H2 receptor antagonists (H2RA’s)
    oBreast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin)
    9)Any of the following findings at Visit 1:
    oProlonged QTcF (QT interval with Fridericia’s correction) (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
    oPositive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
    oPositive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
    10)Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline (Miller et al. 2005), as determined by central review
    11)Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator
    12)Pregnant or breast-feeding female subjects
    13Female subjects of childbearing potential not willing to use contraceptive methods
    14)Male subjects not willing to use contraceptive methods
    15)Subjects not willing to adhere to dietary restrictions during the trial period
    16)Participation in any other interventional trial during the trial period
    17)Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

    E.5 End points
    E.5.1Primary end point(s)
    Nature and frequency of adverse events .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occuring over the trial period
    E.5.2Secondary end point(s)
    a)Change from baseline in forced vital capacity (FVC) value
    b)Plasma concentration of C21 and derived PK parameters evaluated in a sub-set of subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    for a) occurring over 12, 24, and 36 weeks
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 EEA20
    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
    Ukraine
    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
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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