Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-08-01, after 2016-08-10 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 2017-08-01. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectstolerabilitymultipleand pharmacodynamicspharmacodynamics of
Phrases that lowered it: blood pressuremmhg90relevanthealthy male -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 395 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (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
- none of the 14 tracked areas
- Drugs matched to FDA substances
- spesolimab
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
- Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers NCT02525679 · started 2015 · scored riskier than 21% of active trials completed
- A Study to Test How Well Healthy Men Tolerate BI 765250 When Given as an Infusion Into the Vein or as an Injection Under the Skin NCT05151653 · started 2022 · scored riskier than 18% of active trials completed
- Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers NCT02696616 · started 2016 · scored riskier than 17% of active trials completed
- A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men NCT06006598 · started 2023 · scored riskier than 15% of active trials completed
- A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men NCT05857878 · started 2023 · scored riskier than 21% 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.