Late-breaking abstract: Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting the allergen-induced early asthmatic response
Bibliographic record
Abstract
Background The effect of QGE031, a high-affinity humanized anti-IgE antibody, was evaluated versus omalizumab (OMA) and placebo in a bronchial allergen challenge model. Methods In this phase IIa, exploratory, parallel group, double-blind, placebo controlled study, 37 subjects with mild atopic asthma were randomized to three s.c. doses (240mg; N=8, 72mg; N=8 and 24mg; N=8) of QGE031 every two weeks, OMA (N=6; dosed as per dosing table) or placebo (N=7). The study was powered for a 0.05 significance level. Outcome measures were change from baseline in the concentration of inhaled allergen leading to a 15% decline in FEV 1 (PC 15 FEV 1 ) at 12 weeks, pharmacodynamics, safety and tolerability. Results At week 12, the change in PC 15 FEV 1 was ∼ 3 fold higher with 72mg and 240mg QGE031 compared to OMA (Table). The change in PC 15 FEV 1 was dose-dependent against both placebo and OMA, with 24mg QGE031 showing a smaller effect whilst 72mg and 240mg showed a similar effect size. QGE031 elicited dose and time-dependent suppression of free IgE, basophil Fc∈RI, surface IgE expression and skin prick test responses. QGE031 was well tolerated at all dose levels. Table: PC 15 FEV 1 for QGE031 versus placebo and omalizumab at 12 weeks vs placebo vs OMA Ratio 95% CI p-value Ratio 95% CI p-value QGE031 240mg 16 4.2-61 0.0001 3.0 0.78-11 0.10 QGE031 72mg 15 4.0-54 0.0001 2.7 0.72-10 0.14 QGE031 24mg 1.8 0.47-7.0 0.38 0.33 0.090-1.2 0.098 OMA 5.4 1.3-22 0.020 - Conclusion QGE031 240 and 72mg demonstrated greater improvement in bronchial provocation testing compared to placebo, and both doses showed a trend for improvement compared with OMA.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".