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
ClinicalTrials.gov processed this data on May 30, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified May 2024 by Takeda
Sponsor
TakedaInformation Provided by (Responsible Party)
TakedaClinicaltrials.gov Identifier
NCT05353985Other Study ID Numbers: TAK-062-2001
First Submitted: April 26, 2022
First Posted: April 29, 2022
Last Update Posted: May 31, 2024
Last Verified: May 2024
History of Changes
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Study Description
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:
Cohort 1 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar
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.
Cohort 2 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar
Cohort 2 (Age 18 and older): TAK-062 Dose 2 + SIGE Gluten-Bar
Cohort 2 (Age 18 and older): TAK-062 Dose 3 + SIGE Gluten-Bar
Cohort 2 (Age 12 and older): TAK-062 Placebo + Gluten-free SIGE Bar
Cohort 2 (Age 12 and older): TAK-062 Dose 1 + Gluten-free SIGE Bar
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.
Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 357 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Quadruple |
Primary Purpose | Treatment |
Official Title | 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 |
Study Start Date | June 30, 2022 |
Anticipated Primary Completion Date | May 6, 2025 |
Anticipated Study Completion Date | May 6, 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score from Baseline to Week 12 [Baseline (Week -1) 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 severe symptoms.
Secondary Outcome Measures
- Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from Baseline to Week 24 [Baseline (Week -4, Run-in Period) 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.
- Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs [Up to Week 28] Adverse event (AE)= any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (e.g., clinically significant abnormal laboratory value, electrocardiogram[ECG] value, or vital sign measurement), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. TEAE=new onset or worsening AEs after the 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 or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is an important medical event. TEAEs considered related to the study drug as assessed by the Investigator will be reported.
- Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062 [Up to Week 28] A positive ADA participant is defined as a participant who has at least 1 positive ADA result during the study and is 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.
Eligibility Criteria
Ages Eligible for Study | 12 Years and Older (Child, Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
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Contacts and Locations
Sponsors and Collaborators | Takeda |
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More Information
Additional Information
Additional Relevant MeSH Terms
- Celiac Disease
- Malabsorption Syndromes
- Intestinal Diseases
- Gastrointestinal Diseases
- Digestive System Diseases
- Metabolic Diseases