Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (280 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 2024-09-05. 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) (raises risk) · Wording Phrases that raised it: bowelsubjects within subjectspresenceevidence
  Phrases that lowered it: evaluate therelevantto evaluatewill evaluateor primary
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Blinding: double (raises risk) · Design
• Drug's FAERS reports with a death: 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
• Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 80 (lowers risk) · Who can join
• Collaborators: 0 (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Keywords listed: 6 (lowers risk) · Design

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.

• Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) NCT04950127 · started 2021 · scored riskier than 21% of active trials completed
• Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus NCT04510090 · started 2020 · scored riskier than 7% of active trials completed
• Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus NCT03995212 · started 2019 · scored riskier than 46% of active trials terminated
• Colesevelam Versus Placebo in Cholestatic Pruritus NCT00756171 · started 2008 · scored riskier than 19% of active trials completed
• IBAT Inhibitor A4250 for Cholestatic Pruritus NCT02360852 · started 2015 · scored riskier than 38% 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.