Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome

Model scores of the 29,894 trials active now.

Model score 9% 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 20% of the time (389 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-03-31. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: transplantpatientsto severemoderate toprior
  Phrases that lowered it: evaluate theto evaluatestudy toefficacysafety
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Maximum age: 18 (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 1 (lowers risk) · Who can join
• Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history

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.

• Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome NCT02057692 · started 2014 · scored riskier than 28% of active trials completed
• Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis NCT01904058 · started 2013 · scored riskier than 15% of active trials completed
• An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS) NCT02047318 · started 2013 · scored riskier than 86% of active trials completed
• An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome NCT02117713 · started 2015 · scored riskier than 77% of active trials completed
• Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome NCT04674761 · started 2021 · scored riskier than 45% 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.