Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557772
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Phase 2ab Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2ab Randomized Double-blind Placebo-controlled Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2ab randomized double-blind placebo-controlled parallel-group 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease NRCD who are on a gluten free diet GFD with and without simulated inadvertent gluten exposure SIGE
The primary purpose of this study is to demonstrate the efficacy of subcutaneous SC amlitelimab in male and female participants aged 18 to 75 years inclusive with NRCD The study will assess the effect of amlitelimab when compared to placebo to improve or attenuate gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth VhCd ratio The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety tolerability and pharmacokinetics of amlitelimab will also be studied
Study details include
The study duration will be up to 48 weeks for participants not entering the long-term extension study including a 16-week safety follow-up period
The study duration will be up to 32 weeks for participants who enter the long-term extension study
The treatment duration will be up to 28 weeks The number of visits will be up to 10 visits
The primary purpose of this study is to demonstrate the efficacy of subcutaneous SC amlitelimab in male and female participants aged 18 to 75 years inclusive with NRCD The study will assess the effect of amlitelimab when compared to placebo to improve or attenuate gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth VhCd ratio The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety tolerability and pharmacokinetics of amlitelimab will also be studied
Study details include
The study duration will be up to 48 weeks for participants not entering the long-term extension study including a 16-week safety follow-up period
The study duration will be up to 32 weeks for participants who enter the long-term extension study
The treatment duration will be up to 28 weeks The number of visits will be up to 10 visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None