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    Summary
    EudraCT Number:2020-005438-14
    Sponsor's Protocol Code Number:TAK-062-2001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-09-01
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    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 PlanP/268/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda
    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 pointSr Clinical Operations Manager
    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-mailNalja.grissom@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 INNZAMAGLUTENASE
    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 typeup to
    D.3.10.3Concentration number600
    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 (Celiac Disease Symptom Diary), for reducing celiac-related symptoms due to gluten exposure in subjects with CeD (celiac disease) attempting to maintain a GFD (gluten-free diet) 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. Has an adequate comprehension of a gluten-free diet (GFD) assessed by the site investigator after review of responses to a knowledge test. The final determination of a participant's adequate comprehension of a GFD is at the discretion of the investigator.
    2. 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 symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).
    3. Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant.
    4. Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
    5.The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.
    6. The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
    7. Have a body mass index (BMI) between 16 and 45 kilogram per meter square (kg/m^2), inclusive.
    8. The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1). There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.
    E.4Principal exclusion criteria
    1. Has presence of other inflammatory GI disorders/systemic autoimmune diseases having potential to cause persistent GI symptoms like CeD/are not well controlled without use of excluded medication.
    -Examples of exclusionary conditions include inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis/colitis, microscopic colitis diagnosed at screening/requiring treatment in 6 months before screening.
    -Examples of permissible conditions after discussion with medical monitor include systemic autoimmune disease like scleroderma, psoriatic/rheumatoid arthritis/lupus that is stable & without GI involvement; well controlled autoimmune thyroid disease; well-controlled type 1 diabetes/proton pump inhibitor responsive eosinophilic esophagitis in symptomatic & histologically confirmed remission.
    2. Has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for endoscopies/treatment with systemic immunosuppressants/systemic corticosteroids in 12 weeks before Screening.
    Participant is receiving immunosuppressive doses of corticosteroids: 3mg per day/more of budesonide for >3 consecutive days within 3 months before Screening, >20 mg of prednisone given daily/on alternative days for 2 weeks/more within 90 days before first dose, any dose of oral/intravenous (IV) corticosteroids within 30 days of first dose/high-dose inhaled corticosteroids/other systemic immunosuppressive agents.
    3. Has ongoing use of over-the-counter digestive enzymes/digestive supplements, other than lactase, including those for gluten digestion. Probiotics are allowable if started before Screening & not discontinued during study.
    4. Has completed CDSD on ≤75% of evaluable days during run in period until randomization.
    5. Has active microscopic colitis requiring treatment in 6 months before Screening.
    Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude participant.
    6. Has known/suspected type 2 refractory CeD/ulcerative jejunitis.
    7. Has ongoing chronic use of nonsteroidal anti-inflammatory drug except <100 mg aspirin daily for prophylactic use.
    8. Has ongoing use/use in 3 months before screening of medications known to cause villous abnormalities.
    9. Has used treatments for GI symptoms including antiemetics, antidiarrheals, antispasmodics, medical marijuana,(use of medical marijuana indicated for non-GI conditions is not exclusionary) within 2 weeks of Screening & during run-in period. Participants on stable dose(i.e., more than 4 weeks) of an osmotic, bulking-forming/emollient (surface active agent) laxative are eligible, provided symptoms are considered not related to CeD in investigator’s opinion.
    10. Has a known/suspected severe enteric infection(viral, bacterial, parasitic) within 6 months before randomization. Severe enteric infection: Requiring emergency room/hospitalization/treatment with antibiotics due to infection. Non enteric viral infections, either resolved/well-controlled are not exclusionary.
    11. Has contraindication to endoscopy with duodenal biopsy.
    -Contraindication to VCE(strictures, anastomoses, etc) is not exclusion if participant is able to complete other aspects of study.
    12. Has food allergies(e.g., tapioca syrup, oats, etc.) to nongluten ingredients in SIGE bar study food/significant symptoms upon ingestion of gluten-free SIGE bar during screening.
    13. Has a history of intolerance, hypersensitivity/idiosyncratic reaction to aminoglycoside.
    14. Has a known human immunodeficiency virus (HIV) infection/positive tests for hepatitis B/C. Has known clinically significant chronically active hepatopathy of any origin, including cirrhosis & participants with persistent positive hepatitis B virus surface antigen & quantitative hepatitis B virus polymerase chain reaction (PCR)/positive serology for hepatitis C virus (HCV) & quantitative HCV PCR within 6 months before screening visit.
    15. Is positive for severe acute respiratory syndrome coronavirus 2 at time of screening & exhibits symptoms that, in investigator’s opinion, may interfere with study compliance, completion/accurate assessment of study outcomes/safety (direct viral/serologic testing may be performed according to site procedures at investigator’s discretion).
    16. Has known hypersensitivity reaction/allergy, including anaphylaxis, to wheat/gluten.
    17. Has known history of hypersensitivity, idiosyncratic reaction/intolerance to any ingredients/excipients in TAK-062/placebo.
    18. Has current diagnosis of active malignancy/is receiving treatment for active malignancy (hormone therapy alone is not exclusionary). Subjects with fully resected Stage 0/Stage1 tumor without signs of recurrence may participate.
    Region-specific Exclusion Criteria:
    19. Participant enrolling in study in France is not affiliated to social security scheme/beneficiary of such a scheme.
    20. Participant enrolling in study in France is deprived of their liberty by judicial/administrative decision.
    E.5 End points
    E.5.1Primary end point(s)
    Change in weekly CDSD GI symptom severity score from baseline to Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Week -1) to Week 12.
    E.5.2Secondary end point(s)
    Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from baseline (measured at Week -4) to Week 24.
    Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs.
    Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week -4 to Week 24.
    Up to Week 28.
    Up to Week 28.
    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 trial8
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    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.8.9.2In 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: 331
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 357
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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