Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-101 · 1 trial · 1 indication
IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level. |
| Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-101 placebo-matching intravenous infusion |
| TAK-101 | DRUG | TAK 101 intravenous infusion |
| Gluten | DIETARY_SUPPLEMENT | Powder form (vital wheat gluten) |
Inclusion Criteria: 1. Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) \<2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) \<3 × U...
| 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-101 is an investigational small molecule being developed for celiac disease. It is designed to prevent gluten-specific T cell activation in patients with celiac disease who are on a gluten-free diet. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
TAK-101 targets gluten-specific T cell activation. It is intended to modulate the immune response to gluten in patients with celiac disease, potentially reducing the harmful effects of accidental gluten exposure. The drug is being studied for its ability to prevent this specific T cell response.
TAK-101 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is publicly traded on the New York Stock Exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of TAK-101 in celiac disease.
TAK-101 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the prevention of gluten-specific T cell activation in patients with celiac disease on a gluten-free diet.
TAK-101 has one completed Phase 2 clinical trial with the identifier NCT04530123. This was a dose-ranging study evaluating the efficacy and safety of TAK-101 for prevention of gluten-specific T cell activation in participants with celiac disease on a gluten-free diet. The trial enrolled 102 participants across the United States, Australia, Canada, and New Zealand.
TAK-101 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed exclusively by Takeda Pharmaceutical Company Limited for the treatment of celiac disease.