Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (243 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-07-10, after 2015-10-19 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 2020-07-10. 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: subjectchronicweightsubjectssingle
Phrases that lowered it: ulnparticipantssmallproteincount -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Sponsor's past trials: 1058 (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 95 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 3.6% (lowers risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 68.2% (lowers risk) · Drug's FDA history
-
Sponsor type: government (raises risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1058 (typical: 32)
- Sponsor's past termination rate
- 5.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 95 (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
- 10651 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4878 (typical: 412.5)
- Drug's FAERS reports marked serious
- 68.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, metabolic
- Drugs matched to FDA substances
- ustekinumab
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
- GSK2982772 Study in Subjects With Ulcerative Colitis NCT02903966 · started 2016 · scored riskier than 52% of active trials completed
- A First-in-Human Study of BB-TL1A-VIAL-HLE in Healthy Adults and People With Ulcerative Colitis NCT07029971 · started 2025 · scored riskier than 4% of active trials terminated
- Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA NCT06896136 · started 2025 · scored riskier than 4% of active trials completed
- ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 NCT05507216 · started 2023 · scored riskier than 78% of active trials completed
- ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 NCT05507203 · started 2022 · scored riskier than 78% 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.