Trial · NCT06033833
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with treatment-emergent adverse events | From baseline up to Week 156 (EOS of LTS17510) | Percentage of participants with treatment emergent Adverse Events. |
| Secondary | Percentage of participants who experienced adverse events. | From baseline up to Week 156 (End of Study [EOS] of LTS17510) | Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs). |
| Secondary | Annualized rate of severe exacerbation events over treatment period from parent study baseline | From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510) | Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
| Secondary | Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline | From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510) | Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
| Secondary | Time to first exacerbation event from LTS17510 study baseline | From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510) | |
| Secondary | Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline | From baseline of the parent study up to Week 144 (EOT of LTS17510) | Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
| Secondary | Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline | From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510) | Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
| Secondary | Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint | From baseline of parent study up to week 144 (EOT of LTS17510) | |
| Secondary | Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint | From baseline of LTS17510 study up to week 144 (EOT of LTS17510) | |
| Secondary | Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint | From baseline of LTS17510 study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint | From baseline of lTS17510 study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint | From baseline of LTS17510 study up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores | From parent study baseline up to Week 144 (EOT of LTS17510) | The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). |
| Secondary | Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores | From LTS17510 study baseline up to Week 144 (EOT of LTS17510) | The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). |
| Secondary | Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO) | From parent study baseline up to Week 144 (EOT of LTS17510) | |
| Secondary | Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO) | From LTS17510 study baseline up to Week 144 (EOT of LTS17510) | |
| Secondary | Serum amlitelimab concentrations | From baseline up to Week156 (EOS of LTS17510) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06033833/registered