A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Model scores of the 29,894 trials active now.

Model score 6% 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 9% of the time (803 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 2023-01-03. 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: immunogenicityscoresubjectvitamindisease
  Phrases that lowered it: at screeningthe efficacyinvestigatorkgstudy to
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 51.9% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Minimum age: 55 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 150713 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Sponsor's past trials: 17 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Maximum age: 80 (raises 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.

• A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis. NCT05338086 · started 2022 · scored riskier than 8% of active trials completed
• Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis NCT05345691 · started 2022 · scored riskier than 11% of active trials completed
• Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis NCT03974100 · started 2019 · scored riskier than 11% of active trials completed
• Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis NCT05087030 · started 2021 · scored riskier than 12% of active trials completed
• A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis NCT04934072 · started 2021 · scored riskier than 15% 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.