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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR LARAZOTIDE


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Clinical Trials for Larazotide

Trial ID Title Status Sponsor Phase Summary
NCT00620451 ↗ Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate (AT-1001) in Active Celiac Disease Completed Alba Therapeutics Phase 2 The purpose of this research study is to look at how effective and safe larazotide acetate (AT-1001) is when it is given to subjects who have active Celiac Disease. A "leaky gut" is often found in Celiac Disease patients, and it is thought that the leakiness contributes to the disease, possibly by letting more gluten enter the body. Larazotide acetate (AT-100l) is an experimental drug that may possibly reduce gut leakiness and is being investigated to see if it can help people with Celiac disease along with a gluten free diet.
NCT00889473 ↗ Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease Completed Alba Therapeutics Phase 2 This study will look at one dose of AT1001 for efficacy and safety for the treatment of celiac disease. The primary efficacy outcome is the rate of response to gluten.
NCT01396213 ↗ A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease Completed Teva Pharmaceuticals USA Phase 2 A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
NCT01396213 ↗ A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease Completed Alba Therapeutics Phase 2 A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
NCT03569007 ↗ Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Treatment of Celiac Disease Not yet recruiting Innovate Biopharmaceuticals Phase 3 To assess the efficacy and safety of larazotide acetate versus placebo for the treatment of persistent abdominal symptoms in adult celiac disease patients.
NCT05022303 ↗ AT1001 for the Treatment of COVID-19 Related MIS-C Not yet recruiting Massachusetts General Hospital Phase 2 The primary aim of this study is to evaluate the efficacy and safety of AT1001 versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and are at high risk of progression. AT1001 10 μg/kg/dose up to 500 μg/dose or matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Larazotide

Condition Name

Condition Name for
Intervention Trials
Celiac Disease 4
Covid19 1
Multisystem Inflammatory Syndrome in Children 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Celiac Disease 4
Syndrome 1
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Clinical Trial Locations for Larazotide

Trials by Country

Trials by Country for
Location Trials
United States 55
Canada 7
Spain 1
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Trials by US State

Trials by US State for
Location Trials
Minnesota 3
Maryland 3
Kentucky 3
Kansas 3
California 3
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Clinical Trial Progress for Larazotide

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 2
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Clinical Trial Sponsors for Larazotide

Sponsor Name

Sponsor Name for
Sponsor Trials
Alba Therapeutics 3
Teva Pharmaceuticals USA 1
Massachusetts General Hospital 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 5
Other 1
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