Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Model scores of the 29,894 trials active now.

Model score 14% 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 13% of the time (1,304 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 2025-02-03. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: extension studylong termterm safetylabel extensionthe long
  Phrases that lowered it: participantparticipantssafety ofevaluateclinical
• Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
• Blinding: none (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 1 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports marked serious: 90.0% (lowers risk) · Drug's FDA history
• Collaborators: 1 (raises risk) · Design
• Sponsor's past trials: 19 (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.

• A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS) NCT05817669 · started 2023 · scored riskier than 20% of active trials completed
• A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) NCT04598477 · started 2021 · scored riskier than 11% of active trials terminated
• A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid NCT05681481 · started 2023 · scored riskier than 14% of active trials terminated
• Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome NCT03100942 · started 2017 · scored riskier than 88% of active trials completed
• A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults NCT05817435 · started 2023 · scored riskier than 3% 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.