Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE February 7, 2008
First Posted Date  ICMJE February 21, 2008
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
Villous Height to Crypt Depth (Vh:Cd) ratio [ Time Frame: Baseline and at Day 56 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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".
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
To assess the safety and tolerability of AT-1001 [ Time Frame: From Randomization to Follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
Official Title  ICMJE A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: larazotide acetate
    gelatin capsule
    Other Names:
    • AT-1001
    • INN-202
  • Drug: placebo
    gelatin capsule
Study Arms  ICMJE
  • Experimental: Larazotide acetate 4 mg
    larazotide acetate capsules 4 mg TID
    Intervention: Drug: larazotide acetate
  • Experimental: Larazotide acetate 8 mg
    Larazotide acetate capsules 8 mg TID
    Intervention: Drug: larazotide acetate
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2010)
105
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
150
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00620451
Other Study ID Numbers  ICMJE AT1001-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 9 Meters Biopharma, Inc.
Study Sponsor  ICMJE 9 Meters Biopharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Francisco Leon, MD, Ph.D Alba Therapeutics
PRS Account 9 Meters Biopharma, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP