Approval Probability
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Adjusted LOA
ML Risk
TAK-062 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar | PLACEBO_COMPARATOR | TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar | EXPERIMENTAL | TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar | PLACEBO_COMPARATOR | TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar | EXPERIMENTAL | TAK-062 Dose 2, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar | EXPERIMENTAL | TAK-062 Dose 3, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar | PLACEBO_COMPARATOR | TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar | EXPERIMENTAL | TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar | EXPERIMENTAL | TAK-062 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| TAK-062 | DRUG | TAK-062 tablets. |
| Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar | DIETARY_SUPPLEMENT | SIGE gluten bars. |
| TAK-062 Placebo | DRUG | TAK-062 placebo-matching tablets. |
| Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar | DIETARY_SUPPLEMENT | SIGE gluten-free bars. |
Inclusion Criteria: 1. Has an adequate comprehension of a gluten-free diet (GFD) assessed by the site investigator after review of responses to a knowledge test. The final determination of a participant's adequate comprehension of a GFD is at the discretion of the investigator. 2. Has at least 1 Ce...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
TAK-062 is an investigational small molecule being developed for the treatment of celiac disease. It is intended for patients with active celiac disease who are attempting to maintain a gluten-free diet. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TAK-062 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational therapy for celiac disease, with the drug currently in Phase 2 development.
TAK-062 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 clinical trial of TAK-062 in celiac disease has been completed, and the drug remains under investigation for this condition.
TAK-062 has been studied in a Phase 2 clinical trial with the identifier NCT05353985, titled "A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet." This randomized, double-blind, placebo-controlled trial enrolled 153 participants and has been completed.
Yes, TAK-062 is being studied for the treatment of active celiac disease. A completed Phase 2 clinical trial evaluated the drug in participants attempting a gluten-free diet. The trial was conducted in multiple countries, including the United States, Belgium, Canada, France, Italy, Poland, Spain, and the United Kingdom.