Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT05641558 on ClinicalTrials.gov Phase 1/2 Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (industry) Started 2021-10-18 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 10% of the time (41 trials).

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

How it ended

Completed on 2022-10-21, after 2021-10-18 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 2022-10-21. 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: subjectmetastaticcarcinomatreatment withcell
Phrases that lowered it: topicalweeks beforeperiodmonths beforemoderate to
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 10 (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 74.1% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 4122 (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: 1/2 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 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: 2 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 10 (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: 4122 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 560 (typical: 412.5)
Drug's FAERS reports marked serious: 74.1% (typical: 85.6%)
Drug's FAERS reports with a death: 13.8% (typical: 15.9%)

Disease area and drugs

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

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

Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis NCT05544591 · started 2022 · scored riskier than 11% of active trials completed
Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis NCT06173284 · started 2024 · scored riskier than 9% of active trials completed
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS NCT05197023 · started 2022 · scored riskier than 8% of active trials completed
A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China NCT05017480 · started 2021 · scored riskier than 13% of active trials completed
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis NCT06238817 · started 2024 · scored riskier than 15% 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.