Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.
Model scores of the 29,894 trials active now.
Model score 15% 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 10% of the time (139 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-10-17, after 2023-04-24 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 2024-10-17. 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
-
Sponsor's past termination rate: 16.6% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past trials: 1531 (raises risk) · Sponsor's track record
-
Maximum age: 100 (lowers risk) · Who can join
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 166 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: transplantationhistory ofchronicscreeningcondition
Phrases that lowered it: patients whotrialefficacy andand safetyanti -
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: none (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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 100 (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
- 1531 (typical: 32)
- Sponsor's past termination rate
- 16.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 166 (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
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- iptacopan
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 Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy NCT04820530 · started 2021 · scored riskier than 55% of active trials completed
- ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) NCT02946463 · started 2016 · scored riskier than 52% of active trials completed
- Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment NCT04558918 · started 2021 · scored riskier than 58% of active trials completed
- Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) NCT03439839 · started 2018 · scored riskier than 82% of active trials completed
- ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab NCT03056040 · started 2017 · scored riskier than 44% 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.