Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 3% 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 2024-08-19, after 2021-01-05 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 2024-08-19. 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: 15.2% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: extensiontolerabilitymoderate to48to severe
Phrases that lowered it: evaluate thethe pharmacokineticsstudy willto evaluatepatients -
Sponsor's past trials: 1358 (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Maximum age: 99 (lowers risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 143 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 98.3% (raises risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 58 (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (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
- 2
- Number of arms
- 2
- Allocation
- non randomized (typical: 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
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (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
- 1358 (typical: 32)
- Sponsor's past termination rate
- 15.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 143 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 58 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 33 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- iscalimab
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 of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome NCT03905525 · started 2019 · scored riskier than 73% of active trials completed
- Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome NCT02291029 · started 2014 · scored riskier than 86% of active trials completed
- Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome NCT02843659 · started 2016 · scored riskier than 59% of active trials terminated
- A Study of INCB050465 in Primary Sjögren's Syndrome NCT03627065 · started 2019 · scored riskier than 80% of active trials completed
- Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome NCT06203457 · started 2023 · scored riskier than 32% 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.