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Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate (AT-1001) in Active Celiac Disease

This study has been completed.
Information provided by (Responsible Party):
Alba Therapeutics Identifier:
First received: February 7, 2008
Last updated: July 12, 2012
Last verified: January 2010
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.

Condition Intervention Phase
Celiac Disease Drug: larazotide acetate (AT-1001) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With AT-1001

Resource links provided by NLM:

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • Villous Height to Crypt Depth (Vh:Cd) ratio [ Time Frame: Baseline and at Day 56 ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of larazotide acetate (AT-1001) [ Time Frame: From Randomization to Follow-up ]

Enrollment: 105
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: larazotide acetate (AT-1001)
4 mg three times a day for 8 weeks
Experimental: 2 Drug: larazotide acetate (AT-1001)
8 mg three times a day for 8 weeks
Placebo Comparator: 3 Drug: placebo
placebo three times a day for 8 weeks

Detailed Description:

This will be an outpatient, randomized, parallel-group, double-blind, multicenter, 8-week study with the following treatment arms:

  1. larazotide acetate (AT-1001) 4 mg (three times a day)
  2. larazotide acetate (AT-1001) 8 mg (three times a day)
  3. placebo (three times a day)

Subjects will be required to have a baseline/screening biopsy and a follow-up biopsy at Day 56. Subjects will be required to adhere to a gluten free diet for the duration of the study.

Primary Outcome:

* To assess the efficacy of larazotide acetate (AT-1001) versus placebo in inducing remission in subjects with active Celiac Disease. Improvement is defined by changes (Villous Height to Crypt Depth (Vh:Cd) ratio),measured by duodenal-jejunal biopsy.

Secondary Outcome:

*To assess safety and tolerability of larazotide acetate (AT-1001) in subjects with active Celiac Disease.

Estimated Enrollment 106 subjects Estimated Study Start Date: February 2008 Estimated Study Completion Date: December 2009


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age is 18 to 75 years, inclusive
  • Female subjects should be post-menopausal, surgically sterile or women of child bearing potential with a negative serum beta hCG pregnancy test
  • Is diagnosed with Celiac Disease by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG
  • Is willing to comply with a gluten-free diet for the duration of the study

Exclusion Criteria:

  • Has Refractory Celiac Disease or sever complications of Celiac Disease (e.g. Enteropathy-associated T cell Lymphoma - EATL-, ulcerative jejunitis, perforation)
  • Is suspected to have lymphoma or any other serious complication of Celiac Disease
  • Has chronic active GI disease other than Celiac Disease
  • Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00620451

  Show 33 Study Locations
Sponsors and Collaborators
Alba Therapeutics
Study Director: Francisco Leon, MD, Ph.D Alba Therapeutics
  More Information

Additional Information:
Responsible Party: Alba Therapeutics Identifier: NCT00620451     History of Changes
Other Study ID Numbers: AT1001-011
Study First Received: February 7, 2008
Last Updated: July 12, 2012

Keywords provided by Alba Therapeutics:

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases processed this record on August 21, 2017