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Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

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ClinicalTrials.gov Identifier: NCT00620451
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

Brief Summary:
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: larazotide acetate Drug: placebo Phase 2

Detailed Description:
This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, parallel- group, double-blind, multicenter
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
Actual Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Larazotide acetate 4 mg
larazotide acetate capsules 4 mg TID
Drug: larazotide acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202

Experimental: Larazotide acetate 8 mg
Larazotide acetate capsules 8 mg TID
Drug: larazotide acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202

Placebo Comparator: Placebo
Placebo capsules
Drug: placebo
gelatin capsule




Primary Outcome Measures :
  1. Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease [ Time Frame: duodeno-jejunal biopsies were performed at Baseline and Day 56 ]
    Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.


Secondary Outcome Measures :
  1. Assess the safety and tolerability of larazotide acetate [ Time Frame: Up to 8 weeks ]
    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results and ECG results. Plasma larazotide acetate and metabolites, as well as potential serum antibodies against larazotide acetate, were also determined.

  2. To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole. [ Time Frame: Up to 8 weeks ]
    Candidate components of the CeDARS Index measured in this study were GSRS, anti-tTG antibodies, LAMA ratio, Hb, ferritin, body weight, triceps skin fold thickness, BMI, urinary nitrates

  3. To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey. [ Time Frame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4. ]
    The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.

  4. To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects [ Time Frame: Blood draws occurred at Visits 1, 2, 3, 4 and 5. ]
    Blood for serum was drawn for potential future determination of inflammatory mediators that might be involved in the response of Celiac Disease to larazotide acetate, such as cytokines (e.g. TNF-α,IFN-γ) or the putative permeability factor "zonulin".



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

Inclusion Criteria:

  • Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
  • Marsh score ≥ II at screening
  • Positive serum anti-tTG antibodies as determined by screening serology
  • Willing to comply with a gluten-free diet for the duration of the study

Exclusion Criteria:

  • Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
  • 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
  • Has hemoglobin value below 8.5 g/dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620451


Locations
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United States, California
Study Site
Orange, California, United States, 92868
Study Site
San Francisco, California, United States, 94115
United States, Connecticut
Study Site
Torrington, Connecticut, United States, 06790
United States, Florida
Study Site
Jacksonville, Florida, United States, 32207
United States, Kansas
Study Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Study Site
Lexington, Kentucky, United States, 40536
United States, Maryland
Study Site
Hagerstown, Maryland, United States, 21740
Study Site
Silver Spring, Maryland, United States, 20901
United States, Michigan
Study Site
Chesterfield, Michigan, United States, 48047
Study Site
Troy, Michigan, United States, 48084
United States, Minnesota
Study Site
Rochester, Minnesota, United States, 55905
United States, North Carolina
Study Site
Asheville, North Carolina, United States, 28801
Study Site
Harrisburg, North Carolina, United States, 28075
United States, Ohio
Study Site
Gallipolis, Ohio, United States, 45631
United States, Pennsylvania
Study Site
Paoli, Pennsylvania, United States, 19301
Study Site
Philadelphia, Pennsylvania, United States, 19014
Study Site
Pittsburgh, Pennsylvania, United States, 15243
United States, South Dakota
Study Site
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Study Site
Franklin, Tennessee, United States, 37067
United States, Texas
Study Site
Houston, Texas, United States, 77030
Canada, Alberta
Study Site
Edmonton, Alberta, Canada, T6G2X8
Canada, British Columbia
Study Site
Abbotsford, British Columbia, Canada, V5ZIH2
Study Site
Kelowna, British Columbia, Canada, V1Y2H4
Canada, Ontario
Study Site
Richmond Hill, Ontario, Canada, L4B3PB
Spain
Study Site
Palma, Mallorca, Spain, 07014
Study Site
Barcelona, Spain, 08028
Study Site
Huesca, Spain, 22004
Study Site
Leon, Spain, 24005
Study Site
Madrid, Spain, 28007
Study Site
Madrid, Spain, 28034
Study site
Madrid, Spain, 28040
Study Site
Reus, Spain, 43201
Study Site
Valladolid, Spain, 47005
Sponsors and Collaborators
9 Meters Biopharma, Inc.
Investigators
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Study Director: Francisco Leon, MD, Ph.D Alba Therapeutics
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Responsible Party: 9 Meters Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT00620451    
Other Study ID Numbers: AT1001-011
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 9 Meters Biopharma, Inc.:
Treatment
Active
Celiac
Remission
Induction
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases