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

NCTNCT00620451Other idAT1001-011

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 105 participants (actual)
Sponsor: 9 Meters Biopharma, Inc. · Industry
Design: Randomized · Double masking
Countries: 3 countries
United States, Canada, Spain
Start: Feb 2008
Primary completion: Jul 2009
Completion: Dec 2009
First posted: 21 Feb 2008 (estimated)
Last update posted: 20 Sept 2017
Conditions: Celiac Disease

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010

Ph 2
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
NCT00620451
Feb 2008 to Dec 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

larazotide acetateDrug
placeboDrug

Arms3

Experimental
Larazotide acetate 4 mg
larazotide acetate capsules 4 mg TID
Experimental
Larazotide acetate 8 mg
Larazotide acetate capsules 8 mg TID
Placebo comparator
Placebo
Placebo capsules

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.

Secondary outcomes(4)

Assess the safety and tolerability of larazotide acetate
Time frame · Up to 8 weeks
Registry description
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
Registry description
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.
Registry description
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.
Registry description
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".

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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