Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Model scores of the 29,894 trials active now.
Model score 17% 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 16% of the time (369 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-10-25, after 2015-09-28 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-10-25. 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.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 5 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 75 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 5 (typical: 32)
- Sponsor's past termination rate
- 20% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE) NCT00732940 · started 2008 · scored riskier than 28% of active trials terminated
- A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) NCT01484496 · started 2011 · scored riskier than 17% of active trials completed
- CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis NCT02514967 · started 2016 · scored riskier than 83% of active trials terminated
- CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus NCT01395745 · started 2013 · scored riskier than 75% of active trials completed
- Study of VIB7734 for the Treatment of Moderate to Severely Active SLE NCT04925934 · started 2021 · scored riskier than 94% 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.