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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004929-16 | EudraCT Number |
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This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSJ117 | Experimental | low dose, medium dose, or high dose administered as a once daily inhaled dose |
|
| Placebo | Placebo Comparator | placebo comparator administered as once daily inhaled dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSJ117 | Drug | inhaled once daily dose |
| |
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and serious adverse events | An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that is given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug are classified as a treatment emergent adverse event. | 12 weeks |
| Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1 | Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The AUC for time adjusted percent decrease in FEV1 will be compared between CSJ117 and placebo groups. | 12 weeks |
| Late asthmatic response as measured by the maximum percentage decrease in FEV1 | Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1 | Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The time adjusted AUC percent decrease will be compared between CSJ117 and placebo groups. | 6 weeks and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Calgary | Alberta | T2N 4N1 | Canada | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36822634 | Derived | Gauvreau GM, Hohlfeld JM, FitzGerald JM, Boulet LP, Cockcroft DW, Davis BE, Korn S, Kornmann O, Leigh R, Mayers I, Watz H, Grant SS, Jain M, Cabanski M, Pertel PE, Jones I, Lecot JR, Cao H, O'Byrne PM. Inhaled anti-TSLP antibody fragment, ecleralimab, blocks responses to allergen in mild asthma. Eur Respir J. 2023 Mar 9;61(3):2201193. doi: 10.1183/13993003.01193-2022. Print 2023 Mar. |
| Label | URL |
|---|---|
| Results for CCSJ117X2201 from the Novartis Clinical Trials Website | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Drug |
inhaled once daily dose |
|
| Early asthmatic response as measured by the maximum percentage decrease in FEV1 |
Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The maximum percentage decrease will be compared between CSJ117 and placebo groups. |
| 6 weeks and 12 weeks |
| Early asthmatic response as measured by the minimum of the absolute in FEV1 | Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The minimum of the absolute in FEV1 will be compared between CSJ117 and placebo groups. | 6 weeks and 12 weeks |
| Late asthmatic response as measured by the time adjusted AUC in FEV1 | Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The time adjusted in FEV1 will be compared between CSJ117 and placebo groups. | 6 weeks |
| Late asthmatic response as measured by the maximum percentage decrease in FEV1 | Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups. | 6 weeks |
| Late asthmatic response as measured by the minimum absolute FEV1 | Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The minimum absolute in FEV1 will be compared between CSJ117 and placebo groups. | 6 weeks and 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of Tmax | Tmax is the time to reach the maximum concentration after drug administration | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of Cmax | Cmax is the observed maximum plasma concentration following drug administration | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of AUCtau | The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume] | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of Ctrough) | Ctrough is the observed serum (or plasma or blood) concentration that is just prior to the beginning of, or at the end of, a dosing interval. | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of Racc | Racc is the accumulation ratio | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of Lambda_z | Lambda_z is the apparent elimination rate constant | 12 weeks |
| Measurement of CSJ117 serum concentration and calculation of T1/2 | T1/2 is the terminal elimination half-life [time] | 12 weeks |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1V 4G5 | Canada |
| Novartis Investigative Site | Saskatchewan | Saskatchewan | S7K 0M7 | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Großhansdorf | 22927 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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