A Phase 2 interventional study of larazotide acetate and placebo in Celiac Disease, sponsored by 9 Meters Biopharma, Inc.. Completed at 33 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by 9 Meters Biopharma, Inc. · Phase 2, Interventional, and Treatment
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 105 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →9 Meters Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
larazotide acetate capsules 4 mg TID
Drug: larazotide acetate
Larazotide acetate capsules 8 mg TID
Drug: larazotide acetate
Placebo capsules
Drug: placebo
gelatin capsule
Also known as: AT-1001, INN-202
gelatin capsule
Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.
Time frame: duodeno-jejunal biopsies were performed at Baseline and Day 56
Assess the safety and tolerability of larazotide acetate
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.
Time frame: Up to 8 weeks
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.
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
Time frame: Up to 8 weeks
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.
The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.
Time frame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.
To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects
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".
Time frame: Blood draws occurred at Visits 1, 2, 3, 4 and 5.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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9 Meters Biopharma, Inc.