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    Summary
    EudraCT Number:2020-005438-14
    Sponsor's Protocol Code Number:TAK-062-2001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-14
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005438-14
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This clinical research study of TAK-062 (the “Takeda study drug”) is for subjects with celiac disease with ongoing symptoms believed to be related to gluten exposure. They will be randomly assigned to the group receiving either placebo or the study drug. Placebo looks like the study drug but does not contain any active medicine. Subjects should follow normal gluten-free diet throughout the entire study.
    A.4.1Sponsor's protocol code numberTAK-062-2001
    A.5.4Other Identifiers
    Name:INDNumber:137372
    Name:EV codeNumber:SUB221507
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, 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 supportTAKEDA DEVELOPMENT CENTER AMERICA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTAKEDA DEVELOPMENT CENTER AMERICA
    B.5.2Functional name of contact pointBRIAN SONTAG
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLEXINGTON
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16176789258
    B.5.6E-mailBrian.Sontag@takeda.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 TAK-062
    D.3.4Pharmaceutical form 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 INNTAK-062
    D.3.9.2Current sponsor codeTAK-062
    D.3.9.3Other descriptive nameAlicyclobacillus sendaiensis, gliadin peptidase, recombinant
    D.3.9.4EV Substance CodeSUB221507
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboTablet
    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
    Active Celiac Disease in subjects attempting a Gluten-Free Diet
    E.1.1.1Medical condition in easily understood language
    celiac disease combined with gluten-free diet . When people with celiac disease eat gluten (a protein found in wheat, rye, and barley), their immune system attacks and damages the small intestine.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009839
    E.1.2Term Coeliac disease
    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
    To evaluate the efficacy of TAK-062, as measured by the CDSD, for reducing celiac-related symptoms due to gluten exposure in subjects with CeD attempting to maintain a GFD in treated subjects versus placebo controls.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of TAK-062 for improvement of small intestine mucosal injury due to gluten exposure in subjects with CeD attempting to maintain a GFD in treated subjects versus placebo controls.
    To evaluate the safety and tolerability of TAK-062
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is able to provide written informed consent form to participate in the study before completing any study-related procedures.
    2. In the opinion of the investigator, the subject is willing and fully capable of understanding and complying with study procedures including PRO compliance and restrictions defined in this protocol.
    3. The subject has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
    4. The subject has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to
    gluten exposure. The CeD-related symptoms may vary day-by-day as long as the severity of at least 1 symptom is moderate or greater. The subjects must meet symptom criteria to undergo EGD/VCE.
    5. The subject has biopsy-confirmed CeD-or, in subjects with CeD without a producible initial biopsy report, the following additionalinclusion criteria must be met:
    a) Serology (IgA-tTg) at diagnosis or subsequent visit must be at least 2
    times the ULN.
    b) Histology at screening biopsy at Week -4 must be consistent with
    Marsh-Oberhuber score of 2 or greater as read by a central pathologist.
    6. The subject has been attempting to maintain a GFD for at least 12 months as self-reported by the subject.
    7. The subject has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
    8. The subject is HLA-DQ2 and/or HLA-DQ8 positive.
    9. The subject in Cohort 1 is aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
    10. The subject in Cohort 2 is aged 12 to 75 years, inclusive, at the time of signing the informed consent/pediatric assent forms.
    11. The subject is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
    12. The subjects must have a body mass index (BMI) between 16 and 40, inclusive.
    13. The subject is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the screening visit (Visit 1). There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.
    14. A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use highly effective method of contraception (eg, condom with or without spermicide)* from signing of informed consent/pediatric assent forms throughout the duration of the study and for 100 days after last dose of study drug.
    15. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use a highly effective method of contraception* from signing of informed consent/pediatric assent forms throughout the duration of the study and for 40 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
    2. The subject has inadequate renal or hepatic function before randomization based on the following laboratory parameters:
    - Total bilirubin ≥1.5 × ULN unless the subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, or
    - Serum alanine aminotransferase (ALT) or aspartate aminotransferase
    (AST) ≥3 × ULN.
    - Creatinine >1.5 × ULN.
    3. The subject has the presence of other inflammatory GI disorders or systemic autoimmune diseases (including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening, scleroderma, psoriatic or rheumatoid arthritis,lupus) other than those noted below:
    - Thyroid disease that has been well-controlled for at least 6 months.
    - Well-controlled type 1 diabetes (glycosylated hemoglobin <8 and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia).
    4. The subject has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for endoscopies, or treatment with systemic immunosuppressants or systemic corticosteroids in the 12 weeks before screening.
    - The subject is receiving immunosuppressive doses of corticosteroids: 3 mg per day or more of budesonide for more than 3 consecutive days within 3 months before screening, more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the first dose, any dose of oral or IV corticosteroids within 30 days of the first dose, or high-dose inhaled corticosteroids (>960 μg/day of beclomethasone dipropionate
    or equivalent), or other systemic immunosuppressive agents.
    5. The subject has ongoing use of over-the-counter digestive enzymes or digestive supplements,other than lactase, including those for gluten digestion. Probiotics are allowable if they were started before screening and not discontinued or changed in dose or type during the study.
    6. The subject has an inability to swallow the study drug tablet.
    7. The subject has completed the CDSD on ≤75% of the days during Week -8 until randomization.
    8. If more than 10% of planned enrollment in a cohort report a greater than 1 point improvement in PGIS during the SIGE run-in period (Week -2 through Day -1), further subjects showing this degree of improvement will be excluded from the cohort.
    9. The subject has ongoing symptoms that are considered by the investigator to be due to other GI conditions, including irritable bowel syndrome and eosinophilic disorders.
    10. The subject has active microscopic colitis requiring treatment in the 6 months before screening.
    - Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude the subject.
    11. The subject has known or suspected type 2 refractory CeD or ulcerative jejunitis.
    12. The subject has ongoing chronic use (defined as >7 days continuous use) of a nonsteroidal anti-inflammatory drug aside from <100 mg aspirin, daily, for prophylactic use.
    13. The subject has ongoing use, or use in the 3 months before screening, of medications known to cause villous abnormalities (eg, mycophenolate mofetil, angiotensin receptor blockers,colchicine).
    14. The subject used treatments for GI symptoms including antiemetics, antidiarrheals, antispasmodics, medical marijuana and constipation agents other than fiber within 2 weeks of screening.
    15. The subject has a known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before randomization. Severe enteric infection is defined as requiring emergency room visit or hospitalization or treatment with antibiotics or anti-infectives due to infection. Non-enteric viral infections, either resolved or well-controlled are not exclusionary.
    16. The subject has received any investigational compound within 12 weeks (84 days) or 5 half-lives, whichever is longer, before enrollment into the study.
    17. The subject has a contraindication to endoscopy with duodenal biopsy.
    -Contraindication to VCE (strictures, anastomoses, etc) is not an exclusion if the subject is able to complete the other aspects of the study.
    18. The subject has additional food allergies (almond, tapioca syrup,
    oats, rice crisp, chocolate, butter, wheat gluten, cocoa butter, oat flour,
    glycerin, sunflower lecithin, salt, and natural flavors) to nongluten ingredients in the SIGE bar study food or significant symptoms upon ingestion of the gluten-free SIGE bar during screening.
    19. The subject has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an aminoglycoside.

    see protocol for other criteria: 20 to 30
    E.5 End points
    E.5.1Primary end point(s)
    Change in CDSD GI symptom severity score from baseline (Week -1, the last week of the run-in period) to Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week -1, the last week of the run-in period to Week 12.
    E.5.2Secondary end point(s)
    Change in Vh:Cd from baseline (measured at Week -4) to Week 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week -4 to Week 24.
    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 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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    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 EEA39
    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
    United Kingdom
    United States
    Belgium
    France
    Italy
    Netherlands
    Poland
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 21
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 21
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 351
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 377
    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 Decision2023-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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