A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
Model scores of the 29,894 trials active now.
Model score 17% 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 2019-01-09, after 2017-08-09 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 2019-01-09. 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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Sponsor's past termination rate: 17.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: to determineevidencekeybiopsydetermine whether
Phrases that lowered it: participantsopen labelthe effecteffect oflimit of -
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (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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Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 17 (raises risk) · Design
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Design: sequential (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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Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
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Minimum age: 16 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 62 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Primary purpose: basic science (lowers risk) · Design
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Number of arms: 2 (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
- sequential (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 17 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- 65 (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
- 62 (typical: 32)
- Sponsor's past termination rate
- 17.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (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, urogenital
- Drugs matched to FDA substances
- danicopan
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 Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G) NCT03369236 · started 2018 · scored riskier than 45% of active trials completed
- A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471 NCT03459443 · started 2018 · scored riskier than 51% of active trials terminated
- Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN) NCT05162066 · started 2022 · scored riskier than 57% of active trials terminated
- Controlled Trial Evaluating Avacopan in C3 Glomerulopathy NCT03301467 · started 2017 · scored riskier than 69% of active trials completed
- Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease NCT05083364 · started 2022 · scored riskier than 8% 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.