Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-05-14, after 2020-09-01 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-05-14. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: placeboto assesskeysafety tolerabilitypatient
Phrases that lowered it: the efficacyevaluatepatients whoefficacy andand safety -
Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 0.5% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 12.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 39 (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 5 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 1 (lowers risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 18900 (lowers risk) · Drug's FDA history
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Maximum age: 11 (raises risk) · Who can join
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Drug's FAERS reports before start: 36605 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 124 (lowers risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 11 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 124 (typical: 32)
- Sponsor's past termination rate
- 10.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 39 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 36605 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18900 (typical: 412.5)
- Drug's FAERS reports marked serious
- 12.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, immunology, hematology
- Drugs matched to FDA substances
- dupilumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) NCT03633617 · started 2018 · scored riskier than 11% of active trials completed
- Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE) NCT02379052 · started 2015 · scored riskier than 12% of active trials completed
- Dupilumab in Eosinophilic Gastritis NCT03678545 · started 2021 · scored riskier than 24% of active trials completed
- Mepo for Eosinophilic Esophagitis (EoE) Study NCT03656380 · started 2019 · scored riskier than 48% of active trials completed
- Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy NCT03793608 · started 2019 · scored riskier than 8% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.