Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530123
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2020-08-25
Brief Title:
Dose-Ranging Study of 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
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-101 for the Prevention of Gluten-Specific T Cell Activation in Subjects With Celiac Disease on a Gluten-Free Diet
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease CeD on a gluten-free diet GFD
Participants will receive TAK-101 andor placebo through the vein on Day 1 and Day 8 All participants will receive active treatment at Week 24
Participants will receive TAK-101 andor placebo through the vein on Day 1 and Day 8 All participants will receive active treatment at Week 24
Detailed Description:
The drug being tested in this study is called TAK-101 TAK-101 is being tested to treat people who have celiac disease The study has 2 cohorts planned Cohort 1 has 1 dose level and the Cohort 2 may include 1 or 2 additional dose levels depending on safety tolerability and activity observed in Cohort 1 Dosing in the Cohort 2 will be based on data from Cohort 1
The study will enroll approximately 90 patients In Cohort 1 approximately 45 participants will be randomly assigned in 122 ratio in one of the three arm groups which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need Eligible participants in Cohort 1 will receive
Group A 2 infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 micrograms per kilogram µgkg Gluten Epitopes GE TAK-101 at Week 24
Group B 1 infusion dose of 25 µgkg GE TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
Group C 2 infusion doses of 25 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
If it is deemed appropriate to enroll both the TAK-101 50 µgkg GE and the 125 µgkg GE dose levels in Cohort 2 approximately 45 participants may be randomly assigned in 122 ratio in Cohort 2 to receive
Group A Two infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
Group D Two infusion doses of 50 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 50 µgkg GE TAK-101 at Week 24
Group F Two infusion doses of 125 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg GE TAK-101 at Week 24
If it is decided not to open the second cohort at the 50 µgkg GE dose level and if 1 25 µgkg GE dose is recommended to be tested by the independent data monitoring committee IDMC approximately 27 participants will be randomly assigned in 12 ratio to receive
Group E Two infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg GE TAK-101 at Week 24
Group F Two infusion doses of 125 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg TAK-101 at Week 24
This trial will be conducted globally The overall time to participate in this study is approximately 34 weeks Participants will make multiple visits to the clinic and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment
The study will enroll approximately 90 patients In Cohort 1 approximately 45 participants will be randomly assigned in 122 ratio in one of the three arm groups which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need Eligible participants in Cohort 1 will receive
Group A 2 infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 micrograms per kilogram µgkg Gluten Epitopes GE TAK-101 at Week 24
Group B 1 infusion dose of 25 µgkg GE TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
Group C 2 infusion doses of 25 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
If it is deemed appropriate to enroll both the TAK-101 50 µgkg GE and the 125 µgkg GE dose levels in Cohort 2 approximately 45 participants may be randomly assigned in 122 ratio in Cohort 2 to receive
Group A Two infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 25 µgkg GE TAK-101 at Week 24
Group D Two infusion doses of 50 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 50 µgkg GE TAK-101 at Week 24
Group F Two infusion doses of 125 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg GE TAK-101 at Week 24
If it is decided not to open the second cohort at the 50 µgkg GE dose level and if 1 25 µgkg GE dose is recommended to be tested by the independent data monitoring committee IDMC approximately 27 participants will be randomly assigned in 12 ratio to receive
Group E Two infusion doses of placebo 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg GE TAK-101 at Week 24
Group F Two infusion doses of 125 µgkg GE TAK-101 1 infusion dose on Day 1 and 1 infusion dose on Day 8 followed by 1 infusion dose of 125 µgkg TAK-101 at Week 24
This trial will be conducted globally The overall time to participate in this study is approximately 34 weeks Participants will make multiple visits to the clinic and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1253-8169 | REGISTRY | World Health Organization | None |