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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00620451
First received: February 7, 2008
Last updated: July 12, 2012
Last verified: January 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of larazotide acetate (AT-1001) [ Time Frame: From Randomization to Follow-up ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620451

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

Additional Information:
Sponsors web site. Click here to learn more about the AT-1001  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Alba Therapeutics
ClinicalTrials.gov Identifier: NCT00620451     History of Changes
Other Study ID Numbers: AT1001-011
Study First Received: February 7, 2008
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alba Therapeutics:
Treatment
Active
Celiac
Remission
Induction

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013