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    Summary
    EudraCT Number:2018-001272-37
    Sponsor's Protocol Code Number:0173
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-09
    Trial results View 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 ConcernedGreece - EOF
    A.2EudraCT number2018-001272-37
    A.3Full title of the trial
    A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of TD-1473 in Crohn’s Disease
    A.4.1Sponsor's protocol code number0173
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03635112
    A.5.4Other Identifiers
    Name:US INDNumber:139,354
    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 SponsorTheravance Biopharma US, Inc.
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma US, Inc.
    B.5.2Functional name of contact pointClinical Operations - CC
    B.5.3 Address:
    B.5.3.1Street Address901 Gateway Boulevard
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650808 6000
    B.5.5Fax number+1650808 4181
    B.5.6E-mailIBDstudies@theravance.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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form Coated tablet
    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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form Coated tablet
    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 INNNot Assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately-to-Severely Active Crohn’s Disease (CD)
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease (CD)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    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
    The primary objectives of the study are as follows:
    • To assess the effect of TD-1473 compared to placebo in improving Crohn’s Disease Activity Index (CDAI) score at Week 12 in subjects with moderately-to-severely active CD
    • To assess the safety and tolerability of TD-1473
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effects of TD-1473 given for 12 weeks compared to placebo as follows:
    • To induce clinical remission
    • To induce clinical response
    • To induce endoscopic response
    • To improve the Simplified Endoscopy Score for Crohn’s Disease (SES-CD)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Genetic Test
    An optional genetic testing will be performed in all subjects who agree to participate and provide their additional specific consent. The genetic blood sample should be collected at the Day 1 visit
    E.3Principal inclusion criteria
    Inclusion Criteria for Induction:
    1. Subject is willing and able to provide written, signed informed consent at Screening Part 1 prior to start of any study-related procedures
    2. Subject is a male or female at least 18 years of age at the time of Screening
    3. Subject has a history of CD with involvement of at least the ileum or any portion of the colon at a minimum, diagnosed by radiology, endoscopy, and/or histology at least 3 months prior to Screening. The report of a previous diagnostic exam (endoscopy, radiology, and/or pathology) must be reviewed by the investigator and included in the source documents.
    4. Subjects must have up-to-date colorectal cancer screening as per locally adopted guidelines (e.g., if subject has had ≥ 8 years of disease involving >30% of the colon, surveillance biopsies or chromoendoscopy should be performed if either is indicated as per locally adopted guidelines but has not been performed within the 12 months prior to Screening.If indicated, the surveillance biopsies (if ≥ 10) and
    chromoendoscopy need to be performed during Screening Stage 2
    ileocolonoscopy after recording of a full ileocolonoscopy has been
    completed to avoid dye or biopsy related bleeding artifact on the
    recorded images.)
    5. Subject has CDAI score ≥ 220 and ≤ 450 (required in order to proceed to endoscopy during Screening Stage 2 visit)
    6. Subject has a SES-CD score of ≥ 6 (≥ 4 if isolated ileal disease) with ulceration (corresponding to a score of ≥1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD, as assessed by central reading, during Screening
    7. Subject is corticosteroid-dependent or had intolerance or inadequate response to any of the following: aminosalicylates, corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or biologics (anti-TNF anti-IL- 12/IL-23 therapy, or anti- integrin)
    8. If subject is currently receiving an oral corticosteroid, subject is eligible if:
    a. the subject has been on corticosteroid for a minimum of 4 weeks prior to Day 1 AND
    b. the dose is equivalent to or less than prednisone 25 mg/day or budesonide 9 mg/day AND
    c. the dose is stable for at least 2 weeks prior to Screening Stage 2 AND
    d. the subject is willing to continue on the same dose as warranted until Week 8
    9. If subject is currently receiving oral aminosalicylate (including, but not limited to sulfasalazine or mesalamine), the subject is eligible provided the subject has been on a stable dose for ≥ 3 weeks prior to Day 1 and is willing to stay on the same dose as warranted until Week 12
    E.4Principal exclusion criteria
    Exclusion Criteria Pertinent to GI:
    1. Subject with a confirmed or suspected diagnosis or history of primary sclerosing cholangitis (PSC)
    2. Subject has had extensive colonic resection (i.e., more than half of colon), subtotal or total colectomy, intestinal resection within 6 months of Screening, > 2 small bowel resections or carries a diagnosis of short bowel syndrome or currently has an ostomy
    3. Subject has a history of colonic mucosal dysplasia. Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia or because of spontaneous (non-colitis-associated) adenomas that have been completely resected
    Exclusion Criteria Pertinent to Medications:
    1. Medications of exclusion (Refer to Protocol Section 6.4.29 for prohibited medications) below must be discontinued within the timeframe specified (if applicable)
    • azathioprine, 6-mercaptopurine, or methotrexate taken within the 14 days prior to Day 1
    • anti-TNFs (e.g., adalimumab, infliximab, golimumab, etanercept, certolizumab, or biosimilars) taken within the 60 days or 5 half-lives, whichever is shorter, prior to Day 1
    • intravenous corticosteroids within the 14 days prior to Day 1
    • rectal mesalamine or corticosteroid (i.e., enemas or suppositories) taken within the 14 days prior to Day 1
    • prior exposure to vedolizumab, ustekinumab, mycophenolic acid, tacrolimus, sirolimus, or cyclosporine taken within 60 days prior to Day 1
    • Any prior exposure to natalizumab, rituximab, efalizumab, fingolimod, cyclophosphamide, or thalidomide
    • NSAIDs taken on a regular (more than 3 times per week, on average) basis (regular use of aspirin ≤ 325 mg per day for cardiovascular protection is allowed).
    • anakinra or any other immune-modifying biologic agent taken within 90 days, or 5 half-lives, whichever is shorter, prior to Day 1
    2. Any prior exposure to an approved JAK inhibitor or potential exposure to an investigational JAK inhibitor
    3. Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
    4. Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
    Exclusion Criteria Pertinent to Infections:
    1. Subject is positive for:
    a. hepatitis B virus (HBV) surface antigen
    b. hepatitis B virus core antibody (unless subject has positive hepatitis B surface antibody and undetectable serum hepatitis B DNA)
    c. hepatitis C virus (HCV) antibody unless: a) there is evidence of undetectable viral load measured twice six months apart after completion of treatment regimen and b) viral load during Screening is undetectable
    d. hepatitis E antibody
    e. human immunodeficiency virus (HIV) antibody
    2. The subject has or may have untreated active or latent TB as evidenced by any of the following:
    a. Two indeterminate or one positive QuantiFERON®-TB Gold result within 90 days prior to screening or during the Screening Period, without having completed an adequate treatment for latent or active TB before Screening OR
    b. Chest X-ray or equivalent chest imaging within 90 days prior to Screening in which active or latent pulmonary TB cannot be excluded.
    A subject who has a history of latent or active tuberculosis (TB) may be eligible for the study if criteria outlined in Protocol Section 6.4.15 are met.
    3. Subject has:
    a. an active bacterial, parasitic, fungal, mycobacterial (including atypical infection), or viral infection, except for local skin or nail bed infection, within 30 days prior to Day 1
    b. any infection requiring hospitalization or intravenous antibiotics within 30 days prior to Screening
    c. any infection requiring oral antimicrobial treatment within 2 weeks prior to Screening
    d. a history of more than one episode of herpes zoster or one or more episodes of disseminated or complicated herpes zoster (complicated: multi-dermatomal, ophthalmic, or CNS involvement or post-herpetic neuralgia) or disseminated herpes simplex
    4. Subject has C. difficile or other gastrointestinal infections (e.g., Salmonella, Shigella, Yersinia, Campylobacter, E. Coli 0157, etc.) on stool testing or cytomegalovirus [CMV] colitis suspected on endoscopic appearance during Screening. Subject may be treated, re-tested, and re- screened.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    • CDAI score change from baseline at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • CDAI clinical response (defined as reduction from baseline of ≥ 100 points or CDAI < 150) at Week 12
    • CDAI clinical remission (defined as CDAI < 150) at Week 12
    • SES-CD change from baseline at Week 12
    • Endoscopic response (SES-CD reduction of ≥ 50% from baseline or endoscopic remission) at Week 12
    • SFAP clinical remission defined as abdominal pain score ≤ 1 (on a scale of 0-3), stool frequency ≤ 2.8, and both not worse than baseline at Week 12
    Study Safety Endpoints:
    • Changes from baseline in vital signs, ECGs, and clinical laboratory results
    • Incidence and severity of AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Combined Induction and Active Treatment Extension (ATE) phase
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Austria
    Bulgaria
    Croatia
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Ukraine
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 140
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 160
    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 Decision2018-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
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