A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Study Purpose

The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 symptoms 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 biopsy-confirmed CeD. 4. Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant. 5. Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <3.0 at Week -4. 6. The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive. 7. The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator. 8. Have a body mass index (BMI) between 16 and 35 kilogram per meter square (kg/m^2), inclusive. 9. The participant 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.

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, 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/d] 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, constipation agents other than fiber, antispasmodics and medical marijuana 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 (e.g., almond, nuts) 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05353985
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Study Website: View Trial Website
Additional Details

The drug being tested in this study is called TAK-062. TAK-062 designed to break down gluten in the stomach and is being tested to treat people who have active CeD, attempting to maintain a GFD. The study will enroll approximately 350 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1: 1. Cohort 1 (Age 18-75): TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar. 2. Cohort 1 (Age 18-75): TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar. After the interim analysis, Cohort 1 data will be reviewed by an internal review committee (IRC), and based on the Sponsor's decision, 210 adult participants will be enrolled in Cohort 2 and randomly assigned to one of the five drug and SIGE treatment groups, and approximately 20 adolescent participants will be enrolled and randomly assigned to Groups 4 and 5. 1. Cohort 2 (Age 18-75): TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar. 2. Cohort 2 (Age 18-75): TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar. 3. Cohort 2 (Age 18-75): TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar. 4. Cohort 2 (Age 12-75): TAK-062 Dose 1 + Gluten-free SIGE bar. 5. Cohort 2 (Age 12-75): TAK-062 Placebo + Gluten-free SIGE bar. This multi-center trial will be conducted in the United States, Canada, United Kingdom and the European Union. The overall time to participate in this study is approximately 36 weeks.

Arms & Interventions

Arms

Experimental: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar

TAK-062 Dose 1, tablets, orally, taken within pre-determined time at the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Placebo Comparator: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar

TAK-062 placebo-matching tablets, orally, taken within pre-determined time at the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Placebo Comparator: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar

TAK-062 placebo-matching tablets, orally, taken within pre-determined time at the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar

TAK-062 Dose 2 tablets, orally, taken within pre-determined time at the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar

TAK-062 Dose 3 tablets, orally, taken within pre-determined time at the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar

TAK-062 Dose 1 tablets, orally, taken within pre-determined time at the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Placebo Comparator: Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar

TAK-062 placebo-matching tablets, orally, taken within pre-determined time at the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Interventions

Drug: - TAK-062

TAK-062 tablets.

Dietary Supplement: - Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

SIGE gluten bars.

Drug: - TAK-062 Placebo

TAK-062 placebo-matching tablets.

Dietary Supplement: - Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

SIGE gluten-free bars.

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Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Site Contact

Site Contact

jpruthi@omclinicaltrials.com

661-388-2239

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