A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

NCT02696785 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2016-05-02 Completed

Riskier than 25% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (114 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-10-17, after 2016-05-02 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 2018-10-17. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placebo controlledpurpose ofonsethistoryrandomization
Phrases that lowered it: participantsefficacy andpatients withtumorand safety
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 28.3% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 2.0% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor's past trials: 1013 (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 144 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports before start: 133248 (lowers risk) · Drug's FDA history
Blinding: double (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: 3 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (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: not given (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: 1013 (typical: 32)
Sponsor's past termination rate: 6.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 144 (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: 133248 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 80777 (typical: 412.5)
Drug's FAERS reports marked serious: 28.3% (typical: 85.6%)
Drug's FAERS reports with a death: 2.0% (typical: 15.9%)

Disease area and drugs

Disease areas: musculoskeletal
Drugs matched to FDA substances: adalimumab, ixekizumab

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 Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis NCT02757352 · started 2016 · scored riskier than 25% of active trials completed
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis NCT02696798 · started 2016 · scored riskier than 19% of active trials completed
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis NCT04285229 · started 2020 · scored riskier than 15% of active trials completed
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis NCT03129100 · started 2017 · scored riskier than 24% of active trials completed
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis NCT02349295 · started 2014 · scored riskier than 52% 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.