Trial · NCT06033833
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
NCT06033833, Phase 2, Terminated, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study. Trials, record NCT06033833. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06033833
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
- NCT number
- NCT06033833
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 335 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Asthma
- Interventions
- Amlitelimab, Placebo
- First posted
- 2023-09-13
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39393433 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06033833
GET https://conductscience.org/api/trials/v1/NCT06033833/registered?page=2