Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (528 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 2017-06-12. 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: chronicplacebomay applycriteria mayprotocol defined
  Phrases that lowered it: and safetyefficacy andto evaluatesafety ofthe efficacy
• Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Sponsor's past trials: 794 (raises risk) · Sponsor's track record
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports with a death: 6.9% (lowers risk) · Drug's FDA history
• Number of arms: 6 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 239 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, dermatology: Yes (raises risk) · Disease area
• Disease area, respiratory: Yes (raises risk) · Disease area
• Maximum age: 75 (raises risk) · Who can join
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports marked serious: 89.3% (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.

• A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients NCT02649218 · started 2016 · scored riskier than 95% of active trials completed
• Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU) NCT03437278 · started 2018 · scored riskier than 51% of active trials completed
• A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines NCT03580369 · started 2018 · scored riskier than 29% of active trials completed
• This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines NCT03926611 · started 2019 · scored riskier than 46% of active trials completed
• A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria NCT01987947 · started 2013 · scored riskier than 47% 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.