A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
Model scores of the 29,894 trials active now.
Model score 9% 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 9% of the time (238 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2018-03-07, after 2014-07-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2018-03-07. 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: Yes (lowers risk) · Who can join
-
Sponsor's past trials: 1981 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Maximum age: 75 (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 313 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers 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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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectsascendingcelltolerability pharmacokineticspharmacodynamics
Phrases that lowered it: healthyvaccinationsinglevolunteersvaccine -
Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 10 (lowers risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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Collaborators: 1 (raises 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1981 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 313 (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
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in Subjects With Psoriasis NCT02776033 · started 2016 · scored riskier than 45% of active trials completed
- Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects NCT03965533 · started 2019 · scored riskier than 8% of active trials completed
- A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects NCT02386436 · started 2015 · scored riskier than 13% of active trials completed
- A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects NCT03305419 · started 2017 · scored riskier than 8% of active trials completed
- Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Single and 14 Day Repeat Topical Application of GSK1940029 NCT01938482 · started 2013 · scored riskier than 6% 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.