Trial · NCT05769777
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT05769777, Phase 2, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis. Trials, record NCT05769777. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05769777
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT05769777
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 999 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Dermatitis Atopic
- Interventions
- Amlitelimab
- First posted
- 2023-03-15
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes42
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 Events (TEAEs) | Baseline up to end of study (EOS) (Week 284) | Percentage of participants who experienced TEAEs from baseline during the study |
| Primary | Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to EOS (Week 284) | Percentage of participants who experienced TESAEs from baseline during the study |
| Secondary | Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI) | Baseline up to EOS (Week 284) | Percentage of participants who experienced AESI from baseline during the study |
| Secondary | Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG) | Baseline up to EOS (Week 284) | |
| Secondary | Percentage of participants discontinued from study treatment due to Adverse Events (AEs) | Baseline up to EOS (Week 284) | |
| Secondary | Percent change from baseline in Eczema Area and Severity Index (EASI) score | Baseline to EOS (Week 284) | The EASI is an Investigator-assessed tool used to measure the extent (area) and severity of AD. The severity is assessed based on 4 disease characteristics (erythema, induration/papulation, excoriation and lichenification). The extent of involvement of AD is assessed in 4 body regions (head/neck, trunk, upper extremities and lower extremities). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. |
| Secondary | Proportion of participants with at least a 75% reduction from baseline in the EASI (EASI-75) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least a 50% reduction from baseline in the EASI (EASI-50) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least a 90% reduction from baseline in the EASI (EASI-90) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least 100% reduction from baseline in the EASI (EASI-100) | Baseline to EOS (Week 284) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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/NCT05769777
GET https://conductscience.org/api/trials/v1/NCT05769777/registered?page=2