Approval Probability
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CSJ117 · 2 trials · 2 indications
The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the EXACT Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| CSJ117 8mg | EXPERIMENTAL | Intervention: Drug: CSJ117 |
| CSJ117 4mg | EXPERIMENTAL | Intervention: Drug: CSJ117 |
| CSJ117 Placebo | PLACEBO_COMPARATOR | Intervention: Drug: Placebo |
| 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 |
|---|---|---|
| CSJ117 | DRUG | CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device. |
| Placebo | DRUG | Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device |
| Placebo Comparator | DRUG | inhaled once daily dose |
Inclusion Criteria: * Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure * Current or ex-smokers who have a smoking history of at least 10 pack years * Patients who have been treated with a triple combination of ...
CSJ117 is an investigational small molecule being developed by Novartis for respiratory conditions, including asthma and chronic obstructive pulmonary disease (COPD). It has been studied in adult subjects with mild atopic asthma and in patients with COPD.
CSJ117 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its effects on symptoms and pharmacodynamics in respiratory diseases such as asthma and COPD.
CSJ117 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS.
CSJ117 has completed a Phase 1 trial in asthma and a Phase 2 trial in COPD. It is an investigational drug and has not been approved by regulatory authorities.
CSJ117 has been studied in two completed trials. NCT03138811 was a Phase 1 bronchoprovocation study in adults with mild atopic asthma, and NCT04882124 was a Phase 2 study in patients with COPD.
CSJ117 is the sole name used for this investigational compound in the clinical trials. No alternative names have been associated with it in the available study records.