Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

CELIAC-PH2B — results

Primary endpoint, absolute and relative effect where derivable, and harms as reported.

Document identifier
CEI-TR-0129/3
Series
Trial abstract
Version
1.2
Published
09 Feb 2023
Last reviewed
09 Feb 2024
Next review
09 Feb 2026
Identifier
10.71829/cei.trial.129
Certainty
Moderate
Cycle
2023 Q1
Phase
Phase 2b
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Change in a coeliac disease symptom measure during gluten exposureA symptom effect at the lowest dose only, with no effect at higher dosesModerate
Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed.

§3.2Endpoint hierarchy

§3.3Harms as reported

Table 5. Adverse events for Larazotide acetate from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.

EventActive, %Comparator, %Source trial
HeadacheReported at similar rates to placebo
NasopharyngitisSimilar to placebo
Urinary tract infectionReported
Overall safety profileComparable to placebo across the programme, consistent with negligible systemic exposure
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