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    Summary
    EudraCT Number:2021-006881-19
    Sponsor's Protocol Code Number:TV48574-IMM-20036
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-006881-19
    A.3Full title of the trial
    A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD)
    14týdenní randomizovaná, dvojitě zaslepená studie fáze 2b určená ke
    stanovení dávky ke zjištění farmakokinetiky, účinnosti, bezpečnosti a
    snášenlivosti přípravku TEV-48574 u dospělých pacientů se středně
    závažnou až závažnou ulcerózní kolitidou nebo Crohnovou nemocí
    (RELIEVE UCCD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease
    A.3.2Name or abbreviated title of the trial where available
    RELIEVE UCCD
    A.4.1Sponsor's protocol code numberTV48574-IMM-20036
    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 SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D, Inc.
    B.5.2Functional name of contact pointClinical Study Lead
    B.5.3 Address:
    B.5.3.1Street Address145 Brandywine Parkway
    B.5.3.2Town/ cityWest Chester, Pennsylvania
    B.5.3.3Post code19380
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16469156995
    B.5.6E-mailStanislav.Stoyanov@tevapharm.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 nameTEV-48574
    D.3.2Product code TEV-48574
    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 INNTEV-48574
    D.3.9.1CAS number 2750005-84-4
    D.3.9.2Current sponsor codeTEV-48574
    D.3.9.3Other descriptive nameFully human IgG1 monoclonal antibody specific for TL1A
    D.3.9.4EV Substance CodeSUB235342
    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
    Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis or Crohn's disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011400
    E.1.2Term Crohn's colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to characterize the efficacy of TEV-48574 sc administered every two weeks Q2W and to evaluate the efficacy in adult patients with Inflammatory Bowel disease (IBD) (IBD with moderate to severe UC or CD), as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and of 2 different doses of TEV-48574 sc administered Q2W in adult patients with IBD (moderate to severe UC or CD) as assessed by multiple standard measures at week 14.
    Other:
    - to evaluate the safety and tolerability of 2 doses of TEV-48574
    - to evaluate the immunogenicity of 2 doses
    Exploratory objectives include:
    - to evaluate the efficacy of 2 different doses
    - to evaluate the safety and tolerability of 2 different doses
    - evaluate association among exploratory biomarkers and clinical efficacy of TEV 48574
    - to obtain trough serum TEV 48574 concentrations, to compare major pharmacokinetic/PK characteristics between UC and CD patients with healthy volunteers and asthma patients, and, if data allows, to evaluate the pharmacokinetics/pharmacodynamics and/or exposure-response relationship of different doses of TEV-48574 sc
    - to evaluate the effect of genetic polymorphisms on clinical efficacy in adult patients with IBD (moderate to severe UC or CD)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a.Adults of male and female sex (without restrictions on gender) between 18 and 75 years of age, inclusive, at the time of informed consent.
    b.Diagnosis of UC or CD for ≥3 months.
    c.UC pts: Patient with moderate to severe active UC as defined by the 3 component modified Mayo score of 5 to 9, inclusive, with an endoscopic subscore of ≥2 (from central reading)
    d.CD pts: Patient with moderate to severe active CD as determined by a CDAI score of ≥220 and ≤450.
    e.CD pts: SES CD score of ≥6 (≥4 for isolated ileal disease).
    f.UC pts: Active disease beyond the rectum (>15 cm of active disease at the screening endoscopy [sigmoidoscopy]).
    g.Patient must have inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies: corticosteroids, immunosuppressants, or an approved advanced therapy for IBD including biologics (anti-TNF, anti-integrins, anti IL 12/23, or anti-IL-23), JAK inhibitors, or S1P receptor modulators. No more than 3 locally approved classes of biologics.
    •Inadequate response to, loss of response to, or intolerance to corticosteroid treatment is defined as 1 or more of the following:
    -Steroid refractory: persistent symptoms of active disease despite treatment with at least one 4-week induction regimen that included a dose of ≥30 mg prednisone (oral) daily for at least 2 weeks or intravenous (iv) for at least 1 week within the previous 5 years;
    -Steroid dependent: 2 failed attempts to taper steroids below a dose equivalent to 10 mg prednisone (oral) daily within the previous year;
    -Steroid intolerant: history of intolerance to corticosteroids (including, but not limited to, Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection) within the previous 5 years.
    •Inadequate response to, loss of response to, or intolerance to prior immunosuppressant treatment is defined by 1 or more of the following:
    -Persistent signs and symptoms of active disease despite a history of at least one regimen of oral azathioprine (AZA) or 6 mercaptopurine (6-MP) and/or methotrexate consistent with the regional standard of care;
    -History of intolerance to AZA, 6-MP, or methotrexate (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function testing abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, and infection).
    •Inadequate response to, loss of response to, or intolerance to prior advanced therapy for IBD (biologics, JAK inhibitors, and S1P receptor
    modulators) defined as 1 or more of the following:
    -Loss of response: Persistent signs and symptoms of active disease despite at least one induction and one maintenance regimen of the locally approved regimen of anti-TNF inhibitors, anti-integrins, anti-IL-
    12/23 monoclonal antibodies, JAK inhibitors, or S1Preceptor
    modulators.
    -Inadequate response (primary non-response): Persistent signs and symptoms of active disease despite at least one induction regimen of the locally approved highest dosing regimen of anti-TNF inhibitors, anti-integrins, anti-IL-12/23 mAbs or anti-IL-23 mAbs, JAK inhibitors, or S1P receptor modulators.
    -Intolerance: Discontinuation of anti-TNF inhibitors, anti-integrins, anti-IL-12/23 or anti IL-23 Mabs, JAK inhibitors, or S1P receptor modulators due to an adverse drug reaction as determined by treating physician. Such adverse drug reactions include, but are not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function testing abnormalities, lymphopenia, and infections.
    h.patient must have been on a stable dose for the following specified period of time: oral 5-aminosalicylic acid (5-ASA) or sulfasalazine-for at least 4 weeks prior to endoscopy, oral corticosteroids -for at least 2 weeks prior to endoscopy, and 6-MP, AZA, or methotrexate-for 4 weeks prior to endoscopy.
    i.The patient is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
    l.Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal. Women of childbearing potential (WOCBP) must have a negative β-human chorionic gonadotropin test result and practice a highly effective method of birth control (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly; Appendix E) prior to IMP administration and throughout the study or 50 days after the last IMP dose, whichever is longer.
    m. Male patients (including vasectomized) with WOCBP partners (whether pregnant or not) must use condoms after the first IMP administration and throughout the study or until 50 days after the last IMP dose, whichever is longer.
    E.4Principal exclusion criteria
    a.The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician
    b.Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis
    c.Patient has colonic dysplasia or neoplasia (with exception of dysplasia on a completely excised adenomatous polyp [not a sessile one]), toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis.
    d.Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
    e.Patient anticipates requiring major surgery during this study
    f.A patient is Hepatitis B core antibody or surface antigen positive. If HBcAb is positive and/or HBsAg negative, Hepatitis B viral deoxyribonucleic acid (DNA) will be done as reflective test, and, if undetectable, then not exclusionary. Hepatitis C antibody positive with detectable RNAs, or positive human immunodeficiency virus types 1 or 2 at screening.
    g.Tested positive for tuberculosis (TB) at screening by the QuantiFERON® TB Gold Test (unless documentation of prior TB treatment available) or had a history of untreated latent or active TB
    h.A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
    i.A history of more than 2 herpes zoster episodes in the last 5 years or multimetameric herpes zoster.
    j.A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis).
    k.Current or history of chronic liver or biliary disease (with the exception of Gilbert’s syndrome, asymptomatic gallstones or uncomplicated fatty liver disease) at screening or baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) or bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening.
    l.Absolute neutrophil count <1.5x109/L or Hemoglobin <9 g/dL or lymphocyte count <0.8x109/L or platelet count <100,000/mL
    m.The patient has QTc>480 ms
    n.Any acute infection which in the opinion of the investigator compromises the safety of the patient.
    o.The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
    p.The patient has a known hypersensitivity to the IMP and/or excipients.
    q.Presence of a transplanted organ.
    r.A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cancer).
    s.Patient is receiving any of the following therapies within the designated time period:
    -The patient is currently using any systemic immunosuppressant or immunomodulatory biologic or nonbiologic (other than those listed in inclusion criterion “h” and those that are used for IBD) within 30 days or 5 half-lives (whichever is longer) prior to the endoscopy.
    ->9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent within 2 weeks prior to the endoscopy.
    -Topical (rectal) treatment of 5 ASA or intravenous, intramuscular (parenteral), or enema/suppository administration of corticosteroids within 2 weeks prior to the endoscopy.
    -Biologics including anti-TNF, anti-integrins, anti-IL-12/23 or anti-IL-23 within 3 half-lives prior to randomization.
    -Small molecules including JAK inhibitors, or S1P receptor modulators, within 5 half-lives or shorter washout duration if undetectable drug levels can be demonstrated prior to randomization.
    -Other investigational procedures or products, within 30 days or 5 half-lives of investigational product prior to the endoscopy, whichever is longer.
    -Live vaccine within 14 days prior to the first screening visit. Inactivated vaccines (including approved inactivated coronavirus disease 2019 [COVID-19] vaccines) should preferably be completed 14 days before first IMP dosing. If administered during the study, it is recommended to be at least 3 days before and after IMP administration, or as required by local country regulations.
    t.Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse.


    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is response (yes or no) at week 14, where response in UC patients is defined as clinical remission and response in CD patients is defined as endoscopic response. Clinical remission and endoscopic response are determined as follows:
    • Clinical remission at week 14 in patients with moderate to severe UC. Clinical remission is a modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
    - stool frequency subscore of 0 or 1,
    - rectal bleeding subscore of 0, and
    - endoscopic subscore of 0 or 1, where a score of 1 does not include “friability”
    • Endoscopic response at week 14 in patients with moderate to severe CD, defined as a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response (yes or no) at week 14, where response in UC patients is defined as clinical remission and response in CD patients is defined as endoscopic response
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints to be measured in patients with moderate to severe UC are as follows:
    • Clinical response at week 14, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
    • Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1 at week 14
    • Endoscopic remission defined as a Mayo endoscopic subscore of 0 at week 14
    • Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency) at week 14
    • Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale at week 14
    • Histological remission defined as a Robarts Histopathology Index of ≤5 at week 14
    • Histological remission defined as Geboes index score ≤3.1 at week 14.
    The secondary efficacy endpoints to be measured in patients with moderate to severe CD are as follows:
    • Clinical response defined as a ≥100-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline at week 14
    • Clinical remission defined as a CDAI score <150 at week 14
    • Endoscopic remission defined as SES CD score of 0-2, or SES CD score of 0-4, with no individual sub score >1 at week 14
    • Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency) at week 14
    • Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale at week 14
    • Endoscopic response defined as a decrease in modified multiplier (MM)-SES-CD of >50% from baseline at week 14
    • Histologic response defined as a ≥50% decrease in Global Histologic Activity Score from baseline at week 14

    Exploratory endpoints include:
    •Clinical response defined as decrease from baseline of at least 50% in 2-item PRO2 (rectal bleeding and stool frequency) at weeks 2, 4, 6, 8, 10, and 12
    •Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale at weeks 2, 4, 6, 8, 10, and 12
    •Histological remission defined as a Robarts Histopathology Index of ≤5 at week 14
    •Histological remission defined as Geboes index score ≤3.1 at week 14
    The exploratory efficacy endpoints to be measured in patients with moderate to severe CD are as follows:
    • Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and
    stool frequency) at weeks 2, 4, 6, 8, 10, and 12
    • Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale at weeks 2, 4, 6, 8, 10, and 12
    • Endoscopic remission defined as SES CD score of 0-2, or SES CD score of 0-4, with no individual sub score >1 at week 14
    • Histologic response defined as a ≥50% decrease in Global Histologic Activity Score from baseline at week 14
    • Use of concomitant medication
    • Device-related adverse events and malfunctions (for the commercial sc infusion system)
    • Change from baseline at weeks 2, 4, 8, and 14 in protocol-specified serum-resident pharmacodynamic markers
    • Change from baseline in serum and/or gastrointestinal (GI) tissue markers of GI tissue condition (at weeks 2, 4, 8, and 14 for serum; at week 14 for tissue)
    • Change from baseline at week 14 in GI tissue transcriptome
    • Change from baseline in fecal calprotectin or other stool-derived markers at weeks 2, 4, 8, and 14
    • Change from baseline in high sensitivity C-reactive protein (hsCRP) at weeks 2, 4, 8, and 14
    • Change from baseline in serum free and total TL1A at weeks 2, 4, 8, and 14
    • Change from baseline at week 14 in GI tissue TL1A expression
    • Change from baseline in UC-100 at week 14 in patients with moderate to severe UC
    • Change from baseline in protein and/or ribonucleic acid (RNA) expression in peripheral blood mononuclear cells (PBMCs) at weeks 2, 8, and 14
    • Trough serum TEV-48574 concentrations throughout the study (sparse sampling)
    • Population pharmacokinetic parameters (eg, clearance, volume of the central compartment, area under the concentration-time curve, maximum observed drug concentration, and trough drug concentration)
    • Population pharmacokinetic-pharmacodynamic parameters
    • Exposure-response parameters
    • Primary and other efficacy endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 week treatment period
    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 Yes
    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 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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA96
    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
    Moldova, Republic of
    Ukraine
    Canada
    Georgia
    Israel
    Japan
    Serbia
    South Africa
    United Kingdom
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    France
    Germany
    Hungary
    Italy
    Norway
    Poland
    Slovakia
    Spain
    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 months0
    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 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: 167
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 240
    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)
    Patients who complete the 14-week induction treatment period in Study TV48574-IMM-20036 and demonstrate clinical response, including those with clinical remission will be invited to participate in a 44 week maintenance study (Long-term extension (LTE)). Patients will be randomly assigned to receive 1 of 2 active treatments, TEV-48574 900 mg q2w or TEV-48574 300 mg q2w, with an allocation ratio of 1:1 for up to 44 weeks.
    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 Decision2023-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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