Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
Model scores of the 29,894 trials active now.
Model score 12% 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 2023-04-13, after 2021-04-15 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 2023-04-13. 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) (lowers risk) · Wording
Phrases that raised it: therapycelltreatedpriorenrollment
Phrases that lowered it: participantscreeningevaluateproductsdermatitis -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.6% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 4.1% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Sponsor's past trials: 595 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 63 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 7 (lowers risk) · Design
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Drug's FAERS reports marked serious: 64.2% (lowers risk) · Drug's FDA history
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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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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Maximum age: 80 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 43629 (lowers 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.
The trial
Design
- Phase
- 2
- Number of arms
- 7 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 595 (typical: 32)
- Sponsor's past termination rate
- 11.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 63 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 43629 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5298 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology
- Drugs matched to FDA substances
- omalizumab, tezepelumab
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
- A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). NCT03137069 · started 2017 · scored riskier than 12% of active trials completed
- Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine NCT05107115 · started 2021 · scored riskier than 13% of active trials completed
- A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria NCT05528861 · started 2022 · scored riskier than 12% of active trials terminated
- Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) NCT06162728 · started 2023 · scored riskier than 15% of active trials completed
- Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria NCT05774639 · started 2023 · scored riskier than 10% 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.