Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05353985 | A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet | PHASE2 | COMPLETED | 153 | — | — | Jun 30, 2022 | Nov 6, 2024 | Aug 20, 2025 | 102 | United States, Belgium +6 |
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 |