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NCT02597712

YF476 in Barrett's Esophagus

Completed Phase 2 Results posted Last updated 12 April 2021
What this trial tests

Phase 2 trial testing YF476 in Barrett's Esophagus in 27 participants. Completed in 27 December 2017.

Timeline
15 May 2013
Primary endpoint
28 November 2017
27 December 2017

Quick facts

Lead sponsorTrio Medicines Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment27
Start date15 May 2013
Primary completion28 November 2017
Estimated completion27 December 2017
Sites2 locations across United Kingdom, United States

Drugs / interventions tested

Conditions studied

Sponsor

Trio Medicines Ltd. — full company profile →

Who can join

18 and older, any sex, with Barrett's Esophagus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Ki67 Biomarker Expression Primary · Baseline and Week 12

Esophagogastroduodenoscopy (EGD) was performed to enable taking biopsies for assessment of Ki67 expression, a marker of cellular proliferation. Ki67 expression was assessed by immunohistochemistry and calculating the number of Ki67 positive cells per mm\^2 of Barrett's epithelium.

Baseline
GroupValue95% CI
Treatment1539± 514
YF476 Placebo1556± 622
Week 12
GroupValue95% CI
Treatment1575± 620.7
YF476 Placebo1864± 640.3
Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) Secondary · Week 12

Blood samples were taken for assay of biomarkers associated with esophageal adenocarcinoma. Changes in biomarker expression were derived from RNA-Sequencing and calculated as log-fold change comparing the treatment group to the placebo group. The nature of how results are derived by RNA-sequencing means summary statistics cannot be generated individually for each arm and a value has not been calculated for each individual participant. Therefore, results are reported as the relative change in biomarker expression in the treatment arm compared to the placebo arm.

CCK2R, Week 12
GroupValue95% CI
Treatment-1.19
PTGS2, Week 12
GroupValue95% CI
Treatment0.31
DCLK1, Week 12
GroupValue95% CI
Treatment-0.34
Abundance of Biomarkers of Gastric Acid Suppression Secondary · Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment)

Blood samples were taken to assess the effects of YF476 on fasting serum gastrin, a marker of gastric acid suppression

Week 4
GroupValue95% CI
Treatment242.6± 142.3
YF476 Placebo43.6± 9.9
Week 6
GroupValue95% CI
Treatment103.3± 89.9
YF476 Placebo63.9± 32.2
Week 8
GroupValue95% CI
Treatment234.3± 156.5
YF476 Placebo96.4± 54.2
Week 12
GroupValue95% CI
Treatment146.8± 112.8
YF476 Placebo49.2± 20.4
Follow-up
GroupValue95% CI
Treatment94.9± 78.8
YF476 Placebo64.7± 37.7
Abundance of Biomarkers of ECL Cell Hyperplasia Secondary · Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment)

Blood samples were taken to assess the effects of YF476 on fasting plasma CgA, a marker of ECL cell hyperplasia

Week 4
GroupValue95% CI
Treatment3.9± 1.8
YF476 Placebo8.8± 3.7
Week 6
GroupValue95% CI
Treatment1.8± 0.9
YF476 Placebo16.9± 9.8
Week 8
GroupValue95% CI
Treatment3.8± 1.8
YF476 Placebo10.9± 6.0
Week 12
GroupValue95% CI
Treatment2.9± 2.5
YF476 Placebo10.6± 7.4
Follow-up
GroupValue95% CI
Treatment19.8± 26.1
YF476 Placebo11.9± 7.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment
Serious: 1/13 (8%)
Deaths: 0/13
YF476 Placebo
Serious: 0/11 (0%)
Deaths: 0/11

Serious adverse events (1 terms)

ReactionSystemTreatmentYF476 Placebo
Scrotal abscessInfections and infestations
Other adverse events (29 terms — click to expand)

ReactionSystemTreatmentYF476 Placebo
HeadacheNervous system disorders
ConstipationGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Abdominal painGastrointestinal disorders
NauseaGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Abdominal distensionGastrointestinal disorders
Abdominal upper painGastrointestinal disorders
DyspepsiaGastrointestinal disorders
Gatrooesophageal reflux diseaseGastrointestinal disorders
Mouth ulverationGastrointestinal disorders
VomitingGastrointestinal disorders
PresyncopeNervous system disorders
DizzinessNervous system disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Rhintis allergicRespiratory, thoracic and mediastinal disorders
NasopharyngitisInfections and infestations
Rash pustularInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
Chest painGeneral disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
Dermatitis acneiformSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Bundle branch block rightCardiac disorders
HypoglycemiaMetabolism and nutrition disorders
EpistaxisRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Scrotal abscess.

Data from ClinicalTrials.gov NCT02597712 adverse events section.

Sponsor's own description

A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evidence of shared genetic factors in the etiology of gastrointestinal disorders and endometriosis and clinical implications for disease management.
    Yang F, Wu Y, Hockey R, International Endometriosis Genetics Consortium, et al · · 2023 · cited 25× · PMID 37909040 · DOI 10.1016/j.xcrm.2023.101250

Verify or expand the search:

Other trials of YF476

Trials testing the same drug.

Other recruiting trials for Barrett's Esophagus

Currently open trials in the same condition.

Other Trio Medicines Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02597712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing