Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients

Model scores of the 29,894 trials active now.

Model score 8% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-08-30. 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: patientpatientstherapyprioragent
  Phrases that lowered it: evaluate theto evaluatepharmacokineticsalcoholmale
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: double (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Design: sequential (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Responsible party: sponsor (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 75 (raises risk) · Who can join
• Drug's FAERS reports marked serious: no FAERS history (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.

• Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients NCT03857165 · started 2018 · scored riskier than 9% of active trials completed
• Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia NCT06056570 · started 2023 · scored riskier than 15% of active trials completed
• Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout NCT05818085 · started 2023 · scored riskier than 26% of active trials completed
• Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients NCT01416402 · started 2011 · scored riskier than 81% of active trials completed
• Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout NCT02139046 · started 2014 · scored riskier than 40% 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.