Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (176 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 2016-07-31. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: colitisulcerativetherapyregimenprior
  Phrases that lowered it: healthysingleinvestigatorbetween 18subjects
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Number of arms: 10 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: not given (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 55 (lowers risk) · Who can join

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.

• Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis NCT02888379 · started 2016 · scored riskier than 32% of active trials completed
• A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis NCT01045018 · started 2008 · scored riskier than 16% of active trials completed
• Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis NCT01149707 · started 2010 · scored riskier than 26% of active trials completed
• Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis NCT01671956 · started 2015 · scored riskier than 49% of active trials terminated
• A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis NCT01805791 · started 2013 · scored riskier than 68% of active trials terminated

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.