Active Celiac Disease in subjects attempting a Gluten-Free Diet MedDRA version: 20.0 Level: PT Classification code 10009839 Term: Coeliac disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Code: TAK-062
Pharmaceutical Form: Tablet
INN or Proposed INN: TAK-062
Current Sponsor code: TAK-062
Other descriptive name: Alicyclobacillus sendaiensis, gliadin peptidase, recombinant
Concen
Sponsors
TAKEDA
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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) =3 × ULN, or - 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 960 µg/d 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 antieme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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;Primary 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.;Timepoint(s) of evaluation of this end point: Week -1, the last week of the run-in period to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in Vh:Cd from baseline (measured at Week -4) to Week 24.;Timepoint(s) of evaluation of this end point: at Week -4 to Week 24. | — |
Countries
Belgium, Canada, France, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactNamita Singh’s
TAKEDA DEVELOPMENT CENTER AMERICA
Outcome results
None listed