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.
The drug being tested in this study is called TAK-062. TAK-062 is 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 357 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 and older): TAK-062 Placebo + SIGE Gluten-Bar 2. Cohort 1 (Age 18 and older): TAK-062 Dose 1 + SIGE Gluten-Bar After the interim analysis (IA), Cohort 1 data will be reviewed by an external independent data monitoring committee (DMC), and based on the Sponsor's decision, adolescent participants will be enrolled in Cohort 2. Adult participants, 18 years and older will be enrolled into Cohort 2 once Cohort 1 has completed enrolment. Adult participants will be randomly assigned to one of the five study drug and SIGE treatment groups (Groups a-e), and approximately 21 adolescent participants will be enrolled and randomly assigned to Groups d, e, and f (adolescents only). Adolescents in Cohort 2 will receive only gluten-free SIGE bars. 1. Cohort 2 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar 2. Cohort 2 (Age 18 and older): TAK-062 Dose 2 + SIGE Gluten-Bar 3. Cohort 2 (Age 18 and older): TAK-062 Dose 3 + SIGE Gluten-Bar 4. Cohort 2 (Age 12 and older): TAK-062 Placebo + Gluten-free SIGE Bar 5. Cohort 2 (Age 12 and older): TAK-062 Dose 1 + Gluten-free SIGE Bar 6. Cohort 2 (Age 12-17): TAK-062 Dose 2 + Gluten-free SIGE Bar This multi-center trial will be conducted in the United States (US), Canada, United Kingdom and the European Union. The overall time to participate in this study is approximately 36 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
TAK-062 tablets.
SIGE gluten bars.
TAK-062 placebo-matching tablets.
Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12
CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as least squares (LS) mean change from baseline at Week 12, determined using a mixed-effect model for repeated measures (MMRM). A negative change from baseline indicates improvement.
Time frame: Baseline (Week -1) to Week 12
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24
The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. Results are reported as least squares (LS) mean change from baseline at Week 24, determined using an analysis of covariance (ANCOVA) model. A negative change from baseline indicates worsening disease.
Time frame: Baseline (Week -4, Run-in Period) to Week 24
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs
Adverse event(AE)=any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have causal relationship with this treatment.AE can therefore be any unfavorable\&unintended sign(e.g.,clinically significant abnormal laboratory value, electrocardiogram\[ECG\] value,or vital sign measurement),symptom,or disease temporally associated with use of drug whether or not it is considered related to drug.TEAE=new onset or worsening AEs after first dose of study treatment regardless of relationship to study drug.SAE=any untoward medical occurrence at any dose that results in death,is life threatening,requires inpatient hospitalization/prolongation of existing hospitalization,results in persistent/significant disability/incapacity,leads to a congenital anomaly/birth defect/is important medical event. TEAEs considered related to study drug as assessed by investigator were reported.Percentages were rounded off to nearest single decimal place.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SIGE gluten-free bars.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Research Solutions of Arizona, PC
Litchfield Park, Arizona, United States
One of a Kind Clinical Research Center LLC
Paradise Valley, Arizona, United States
Mayo Clinic- Arizona
Scottsdale, Arizona, United States
GI Alliance- Sun City
Sun City, Arizona, United States
Adobe Clinical Research LLC
Tucson, Arizona, United States
Gastroenterology and Liver Institute
Escondido, California, United States
Om Research LLC
Lancaster, California, United States
So. California Research Institute Med Group Inc./West Gastroenterology Med Group
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
...and 92 more locations
Time frame: Up to Week 28
Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062
A positive ADA participant was defined as a participant who had at least 1 positive ADA result during the study and was further categorized as: Transiently positive- defined as participants with confirmed positive ADA in at least 1 sample and no consecutive samples; Persistently positive- defined as participants with confirmed positive ADA in 2 or more consecutive positive ADA samples.
Time frame: Up to Week 28