Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)

NCT02647086 on ClinicalTrials.gov Phase 1 Regeneron Pharmaceuticals (industry) Started 2015-12-31 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 9% of the time (238 trials).

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

How it ended

Completed on 2016-07-31, after 2015-12-31 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 2016-07-31. 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) (lowers risk) · Wording Phrases that raised it: the followingbaselinemedicationsmetastaticrecent
Phrases that lowered it: patients whovisitperioddayad
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 73.5% (lowers risk) · Drug's FDA history
Primary purpose: basic science (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 67 (lowers risk) · Sponsor's track record
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 76318 (raises risk) · Drug's FDA history

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 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (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: 67 (typical: 32)
Sponsor's past termination rate: 7.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 24 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 6 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 347984 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 76318 (typical: 412.5)
Drug's FAERS reports marked serious: 73.5% (typical: 85.6%)
Drug's FAERS reports with a death: 11.0% (typical: 15.9%)

Disease area and drugs

Disease areas: immunology, dermatology
Drugs matched to FDA substances: caffeine, dupilumab, metoprolol, midazolam, omeprazole, warfarin

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

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates NCT06686628 · started 2024 · scored riskier than 8% of active trials completed
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis NCT00703573 · started 2008 · scored riskier than 8% of active trials completed
A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants NCT05067439 · started 2021 · scored riskier than 4% of active trials completed
A Study to Evaluate Skin and Plasma Pharmacokinetic of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants NCT06505265 · started 2024 · scored riskier than 4% of active trials completed
HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI NCT05602597 · started 2022 · scored riskier than 1% 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.