Trial · NCT05492578
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
NCT05492578, Phase 2, Phase 3, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials. Trials, record NCT05492578. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05492578
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 Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
- NCT number
- NCT05492578
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,856 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Dermatitis Atopic
- Interventions
- Amlitelimab, Topical corticosteroids, Topical calcineurin inhibitors, Oral corticosteroids
- First posted
- 2022-08-08
- Last updated
- 2026-10-13
- Other registries' IDs
- eudract:2021-002344-73
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants who experienced treatment-emergent adverse event (TEAE) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced treatment-emergent serious adverse events (SAEs) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced TEAE leading to treatment discontinuation | Baseline to Week 332 | |
| Secondary | Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: \>= 50% reduction in score from baseline; EASI75: \>= 75% reduction in score from baseline; EASI90: \>= 90% reduction in score from baseline; EASI100: \>= 100% reduction in score from baseline. |
| Secondary | Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Proportion of participants with vIGA-AD score 0 [each LTS17367 visit] | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05492578
GET https://conductscience.org/api/trials/v1/NCT05492578/registered?page=2