Table 2.

Aims and efficacy results of trial CLIN 1001-004.

Aims	Efficacy results
Primary efficacy outcome:
LAMA ratio	• Between gluten challenge groups, the 1 mg larazotide acetate treatment arm had the least LAMA ratio changes from baseline; however, this was not statistically significant. • LAMA ratio was not significantly greater in the gluten challenge arm compared with the gluten-free control group. • Among patients who received gluten, there were not significant changes between the larazotide acetate treatment groups and the placebo group.
Secondary efficacy outcomes:
Gastrointestinal severity symptoms	According to changes in total GSRS and CeD-GSRS score from baseline: • symptoms were more severe in the gluten challenge groups compared with the gluten-free control group (placebo drug/placebo gluten) • symptoms were less severe in larazotide acetate treatment arms compared with the gluten challenge control group (placebo drug/gluten) 0.25 and 4 mg larazotide acetate treatment significantly prevented symptom worsening compared with controls.
Quality of life	According to changes in the total PGWBI from baseline: • there was no significant difference between the larazotide acetate treatment arms and the gluten challenge control group
Anti-tTG antibodies	• Despite gluten challenges, the anti-tTG antibody titers remained negative (<10 U/ml). • There was no significant difference between the larazotide acetate treatment arms and the gluten challenge control group.

CeD-GSRS, Celiac Disease Gastrointestinal Rating Symptoms Scale; GSRS, Gastrointestinal Rating Symptoms Scale; LAMA, lactulose to mannitol; PGWBI, Psychological General Well-Being Index; tTG, tissue transglutaminase.