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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00620451
First received: February 7, 2008
Last updated: September 15, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Celiac Disease Drug: larazotide acetate Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Innovate Biopharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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

  • 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.

  • 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".


Enrollment: 105
Actual 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: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  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 ClinicalTrials.gov identifier: NCT00620451

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

Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00620451     History of Changes
Other Study ID Numbers: AT1001-011
Study First Received: February 7, 2008
Last Updated: September 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Innovate Biopharmaceuticals:
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 September 21, 2017