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    Summary
    EudraCT Number:2022-002593-89
    Sponsor's Protocol Code Number:TV48574-IMM-20038
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-01-12
    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 number2022-002593-89
    A.3Full title of the trial
    A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability of
    TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Long-Term 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 LTE
    A.4.1Sponsor's protocol code numberTV48574-IMM-20038
    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 UK Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRidings Point, Whistler Drive
    B.5.3.2Town/ cityCastleford
    B.5.3.3Post codeWF10 5HX
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailMedInfo@tevaeu.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.3.9.2Current 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
    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 100000004856
    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 100000004856
    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 and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every
    2 weeks (Q2W) in adult patients with IBD (UC or CD) as assessed by maintenance of clinical remission (UC) and endoscopic response (CD) at week 24.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and dose response of 2 different maintenance dose regimens 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 24.

    Other:
    - to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574
    - to evaluate the immunogenicity of 2 different dose regimens of TEV-48574

    Exploratory objectives include:
    - to evaluate association among exploratory biomarkers and clinical efficacy of TEV-48574 in adult patients with IBD (UC or CD)
    - to obtain trough serum TEV-48574 concentrations, to evaluate pharmacokinetics, and, if data allow, to evaluate the pharmacokinetics/pharmacodynamics relationship of 2 different dose regimens of TEV-48574 sc.
    - to evaluate the effect of genetic polymorphisms on clinical efficacy in adult patients with IBD (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) who at the time of informed consent achieved clinical response and/or clinical remission in the 14-week TV48574-IMM-20036 DRF study
    - Clinical response assessed by decrease from baseline in modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score by ≥2 points and at least 30%, with a decrease in rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1 at week 14 of the of the TV48574-IMM-20036 DRF study in patients with moderate to severe UC .
    - Clinical remission at week 14 of the TV48574-IMM-20036 DRF study 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”
    - Clinical response assessed by ≥100-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline week 14 of the TV48574-IMM-20036 DRF study in patients with moderate to severe CD
    - Clinical remission defined as a CDAI score <150 at week 14 of the TV48574-IMM- 20036 DRF study in patients with moderate to severe CD
    b. Patients who are women of childbearing potential (WOCBP) should have a negative β- human chorionic gonadotropin test result and practice a highly effective method of birth control.
    • Male patients (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study
    c. The patient must be willing and able to comply with study restrictions and to remain at the investigational center for the required duration during the study period, and willing to return to the investigational center for further visits, as applicable, and the follow-up procedures and assessments as specified in this protocol
    E.4Principal exclusion criteria
    a. Patients who discontinued the TV48574-IMM-20036 DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and patients who didn’t meet the definition of clinical response or clinical remission based on their DRF week 14 assessment
    b. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
    c. Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
    d. Patient has colonic dysplasia or neoplasia, 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.
    e. 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 study visit.
    f. Patient anticipates requiring major surgery during this study.
    g. A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis).
    h. A history of more than 1 herpes zoster episode or multimetameric herpes zoster.
    i. A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis).
    j. Current or history of chronic liver or biliary disease (with the exception of Gilbert’ syndrome, asymptomatic gallstones or uncomplicated fatty liver disease) or alanine aminotransferase (ALT) >2x upper limit of normal (ULN) and bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening.
    k. Absolute neutrophil count <1.5x109/L or Hemoglobin <8 g/dL or lymphocyte count <0.8x109/L or platelet count <100,000/mL
    l. The patient has QTc>480 ms
    m. Patients with clinical symptoms that may indicate coronavirus disease 2019 (COVID-19) infection, and/or patients who, in the investigator’s opinion, were at high risk of exposure to COVID-19 within 6 weeks before the first study visit, will be tested for active COVID- 19 infection and will be excluded if they test positive for COVID-19. Patients who were admitted to an intensive care unit during a prior COVID-19 infection, patients who contracted or recovered from COVID-19 during the transition from DRF to LTE study, or patients with long-term COVID-19 symptoms are excluded from the study.
    n. 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.
    o. The patient has a known hypersensitivity to the IMP and/or excipients.
    p. Presence of a transplanted organ.
    q. 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
    r. Patient has or is receiving any of the following therapies during the DRF study and/or within the transition period from the DRF study to the LTE study
    - The patient is currently using any systemic immunosuppressant or immunomodulatory biologic or nonbiologic
    - >9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent
    - Topical (rectal) treatment of 5-aminosalicylic acid (5-ASA) or intravenous, intramuscular (parenteral), or enema/suppository administration of corticosteroids
    - Biologics including anti-TNF inhibitors, anti-integrin inhibitors, and anti-IL- 12/23 inhibitors
    - Small molecules including janus kinase (JAK) inhibitors, or sphingosine-1- phosphate (S1P) receptor modulators
    - Other investigational procedures or products excluding IMP
    - Live vaccine. Inactivated vaccines (including approved inactivated 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
    s. Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
    t. Patients with incurable diseases, persons in nursing homes, and patients incapable of giving informed consent
    u. The patient is either an employee or an immediate relative of an employee of the sponsor or of any of the clinical investigational centers participating in the study
    E.5 End points
    E.5.1Primary end point(s)
    -Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a
    stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 24 in patients with UC
    - Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) of at least 50% from DRF study baseline at week 24 in patients with CD
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    - Clinical response, based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at
    least a 30% reduction from DRF study 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 at week 24 in patients with UC
    - Endoscopic improvement from DRF study baseline based on Mayo endoscopic subscore of 0 or 1 at week 24 in patients with UC
    - Endoscopic remission based on Mayo endoscopic subscore of 0 at week 24 in patients with UC
    - Clinical response defined as decrease from DRF study baseline of atleast 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency) at weeks 0, 4, 8, 10, 12, 16, 20, and 24 in patients with UC
    - Clinical remission based on PRO2 (rectal bleeding=0 and stool frequency=0) at weeks 0, 4, 8, 10, 12, 16, 20 and 24 in patients with UC
    - Histological remission based on Robarts Histopathology Index (RHI ≤5) at week 24 in patients with UC
    - Histological remission based on Geboes index score ≤3.1 in patients with UC
    - Clinical response based on Crohn’s Disease Activity Index (CDAI): ≥100-point decrease in CDAI score from DRF study baseline at week 24 in patients with CD at weeks 0, 4, 8, 10, 12, 16, 20 and 24
    - Clinical remission based on CDAI score <150 at week 0, 4, 8, 10, 12, 16, 20 and 24 in patients with CD
    - Endoscopic remission based on SES-CD: SES-CD score of 0-2, or SES-CD score of 0-4, with no individual sub score >1 at week 24 in patients with CD
    - Clinical response defined as decrease in PRO2 from DRF study baseline of at least 50% in PRO2 at weeks 0, 4, 8, 10, 12, 16, 20 and 24 in patients with CD
    - Clinical remission based on PRO2 (abdominal pain ≤1 and stool frequency ≤3) at weeks 0, 4, 8, 10, 12, 16, 20 and 24 in patients with CD
    - Endoscopic response, defined as a decrease in modified multiplier (MM)-SES-CD of >50% from DRF study baseline at week 24 in patients with CD
    - Histologic response (≥50% decrease) in Global Histologic Activity Score from DRF study baseline at week 24 in patients with CD

    Other secondary endpoints include:
    Safety and tolerability measures/parameters as follows:
    - Frequency of adverse events
    - Change from baseline (LTE baseline) in clinical laboratory test results (serum chemistry, hematology, and urinalysis)
    - Change from baseline (LTE baseline) in vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate)
    - Change from baseline (LTE baseline) in 12-lead electrocardiogram (ECG) findings
    - Use of concomitant medication
    - Number (%) of patients who stopped the IMP due to adverse events
    - Local tolerability at the injection site
    - Device-related adverse events and malfunctions (for the commercial sc infusion system)

    Immunogenicity endpoints as follows:
    - Treatment-emergent anti-drug antibody (ADA) results and responses: change from baseline (DRF study) and throughout the study
    - Neutralizing ADA in ADA positive patients throughout the study.
    - Impact of the presence of ADAs on pharmacokinetics and clinical safety will be assessed if applicable

    Exploratory endpoints include:
    - Change from DRF study baseline and from LTE baseline at weeks 4, 8, 14, 20 and 24 in select serum resident pharmacodynamic markers
    - Change from DRF study baseline and from LTE baseline in serum and/or gastrointestinal (GI) tissue markers of GI tissue condition at weeks 4, 8, 14, 20 and 24 for serum; at week 24 for tissue
    - Change from DRF study baseline and from LTE baseline at week 24 in GI tissue transcriptome
    - Change from DRF study baseline and from LTE baseline in fecal calprotectin at weeks 4, 8, 14, 20 and 22
    - Change from DRF study baseline and from LTE baseline in high sensitivity C-reactive protein (hsCRP) at weeks 4, 8, 14, 20 and 24
    - Change from DRF study baseline and from LTE baseline in serum free and total TL1A at weeks 0, 4, 8, 14, 20 and 24
    - Change from DRF study baseline and from LTE baseline at week 24 in GI tissue TL1A expression
    - Change from DRF study baseline and from LTE baseline in UC-100 at week 24 in patients with UC
    - Trough serum TEV-48574 concentrations throughout the study
    (sparse sampling)
    - If performed, population pharmacokinetic analysis results may be reported separately from the main study results.
    - If performed, pharmacokinetics/pharmacodynamics modeling resultswill be reported separately from the main study results.

    Primary and additional efficacy endpoints may be included.
    - If performed, pharmacogenetic analysis results will be reported separately from the main study results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The tested drug given at one dose is compared to a different dose of the same product.
    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 EEA88
    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
    Canada
    Israel
    United States
    Austria
    France
    Poland
    Bulgaria
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Hungary
    Norway
    Slovakia
    United Kingdom
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 128
    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)
    After the end of the 24-week treatment period, patients will be advised to return to their treating physician for appropriate treatment following completion of the study.
    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 Decision2023-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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