Efficacy of CSJ117 on allergen-induced asthmatic response in mild atopic asthma patients
Bibliographic record
Abstract
Introduction: CSJ117 is a potent neutralizing antibody fragment against human Thymic stromal lymphopoietin (TSLP). Methods: In this double-blind, placebo-controlled study, 28 mild, atopic asthmatics were randomized to receive 4 mg CSJ117 (n = 15) or placebo (n = 13) for 12 weeks. Allergen inhalation challenge (AIC) was conducted at screening, day 42 and day 84. The primary efficacy variable was the late asthmatic response (LAR), measured 3 to 7 hours after AIC at day 84. Other outcomes included the early asthmatic response (EAR) measured within 2 hours after AIC, fractional exhaled nitric oxide (FeNO) level, and sputum eosinophils. Data were analyzed using one-sided repeated measures ANOVA (β = 10%) with baseline as covariate. Results: CSJ117 attenuated the allergen-induced LAR and EAR at day 84. The time-adjusted AUC percentage decrease and the maximum decrease in FEV1 from pre-AIC were significantly lower in the CSJ117 group, compared to placebo (4.20% vs. 11.38%, p = 0.008, and 9.28% vs. 17.70%, P = 0.029, during LAR; 12.83% vs. 17.09%, P = 0.097, and 25.48% vs. 30.90%, P = 0.105, during EAR). CSJ117 significantly attenuated the allergen-induced increase in % sputum eosinophils after AIC on day 84. CSJ117 significantly reduced FeNO before AIC at Day 83, but did not affect the allergen-induced change. Conclusion: CSJ117 reduced both allergen-induced bronchoconstriction and sputum eosinophilia, as well as FeNO levels pre AIC. These findings demonstrate CSJ117’s ability to attenuate airway inflammation in allergic asthmatics and support further studies as an inhaled anti-TSLP. Publication History Article published online: 30 April 2021 © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".