A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

NCT03616912 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2018-08-02 Terminated

Riskier than 57% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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 9% of the time (336 trials).

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

How it ended

Terminated on 2022-03-09, after 2018-08-02 start.

Reason given by the sponsor: “safety”

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 2022-03-09. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: scorelupussystemicerythematosusinvestigational product
Phrases that lowered it: participantsscreeningparticipanthematologicalhave received
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 1173 (raises risk) · Sponsor's track record
Sponsor's past termination rate: 6.4% (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 143 (lowers risk) · Sponsor's track record
Number of arms: 6 (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 95.5% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Blinding: double (raises risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports before start: 88 (lowers risk) · Drug's FDA history
Maximum age: not given (lowers risk) · Who can join

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: 6 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 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: 1173 (typical: 32)
Sponsor's past termination rate: 6.4% (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: 88 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 76 (typical: 412.5)
Drug's FAERS reports marked serious: 95.5% (typical: 85.6%)
Drug's FAERS reports with a death: 11.4% (typical: 15.9%)

Disease area and drugs

Disease areas: immunology, dermatology
Drugs matched to FDA substances: baricitinib

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 Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II) NCT03616964 · started 2018 · scored riskier than 59% of active trials completed
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) NCT02708095 · started 2016 · scored riskier than 31% of active trials completed
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus NCT05123586 · started 2022 · scored riskier than 49% of active trials terminated
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis NCT02514967 · started 2016 · scored riskier than 83% of active trials terminated
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus NCT03252587 · started 2017 · scored riskier than 58% 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.