Inclusion Criteria:
1. Has an adequate comprehension of a GFD assessed by completion of a knowledge test
after viewing of educational materials.
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 40 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.
Exclusion Criteria:
1. 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).
2. Has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding
medication given for the endoscopies, or treatment with systemic immunosuppressants or
systemic corticosteroids in the 12 weeks before Screening.
• The participant 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 intravenous
(IV) corticosteroids within 30 days of the first dose, or high-dose inhaled
corticosteroids (>960 micrograms per day [μg/day] of beclomethasone dipropionate or
equivalent), or other systemic immunosuppressive agents.
3. 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.
4. Has completed the CDSD on ≤75% of the days during Week -8 until randomization.
5. Has active microscopic colitis requiring treatment in the 6 months before Screening.
• Microscopic colitis detected at screening if sigmoidoscopy is performed would
exclude the participant.
6. Has known or suspected type 2 refractory CeD or ulcerative jejunitis.
7. 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.
8. Has ongoing use, or use in the 3 months before screening, of medications known to
cause villous abnormalities (e.g., mycophenolate mofetil, angiotensin receptor
blockers, colchicine).
9. Has used treatments for GI symptoms including antiemetics, antidiarrheals,
antispasmodics, medical marijuana, and constipation agents other than fiber, within 2
weeks of Screening.
10. 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.
11. Has a contraindication to endoscopy with duodenal biopsy.
--Contraindication to VCE (strictures, anastomoses, etc) is not an exclusion if the
participant is able to complete the other aspects of the study.
12. Has additional food allergies (tapioca syrup, oats, almonds, rice crisp, chocolate,
almond, 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.
13. Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an
aminoglycoside.
14. Has a known human immunodeficiency virus (HIV) infection or positive tests for
hepatitis B or C. The participant has a known clinically significant chronically
active hepatopathy of any origin, including cirrhosis, and participants with
persistent positive hepatitis B virus surface antigen and quantitative hepatitis B
virus polymerase chain reaction (PCR), or positive serology for hepatitis C virus
(HCV) and quantitative HCV PCR within 6 months before the screening visit.
15. Has known or suspected coronavirus disease 2019 (COVID-19) as determined by the
investigator within the past month or COVID-19-related symptoms that have not resolved
(direct viral or serologic testing may be performed according to site procedures at
the discretion of the investigator).
16. Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat
and/or gluten.
17. Has known history of hypersensitivity, idiosyncratic reaction, or intolerance to any
ingredients or excipients in TAK-062 and/or placebo.
Region-specific
Exclusion Criteria:
18. Participant enrolling in a study in France is not affiliated to a social security
scheme or a beneficiary of such a scheme.
19. Participant enrolling in a study in France is deprived of their liberty by a judicial
or administrative decision.
