RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Model scores of the 29,894 trials active now.

Model score 20% for any early termination, 4% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-08-11. 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.

• Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: to screeningand total30chronickey
  Phrases that lowered it: safety ofulnevaluate theto evaluateacid
• Accepts healthy volunteers: No (raises risk) · Who can join
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 35 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Blinding: double (raises risk) · Design
• Collaborators: 0 (raises risk) · Design
• Keywords listed: 2 (raises risk) · Design
• Sponsor type: industry (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.

• ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) NCT03602560 · started 2018 · scored riskier than 82% of active trials completed
• An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) NCT04950764 · started 2021 · scored riskier than 17% of active trials completed
• A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis NCT03394924 · started 2017 · scored riskier than 85% of active trials completed
• Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) NCT06060665 · started 2023 · scored riskier than 59% of active trials completed
• Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis NCT05642468 · started 2023 · scored riskier than 70% 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.