Trial · NCT06118099
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06118099, Phase 2, Terminated, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa. Trials, record NCT06118099. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06118099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- NCT number
- NCT06118099
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Hidradenitis
- Interventions
- Amlitelimab, Placebo
- First posted
- 2023-11-07
- Last updated
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16 | Week 16 | Hidradenitis suppurativa clinical response (HiSCR)50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count. |
| Secondary | Time to onset of achieving HiSCR50 | From baseline to Week 16 | HiSCR50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count. |
| Secondary | Absolute change from baseline in AN count at Week 16 | Baseline to Week 16 | AN count is the total abscess and inflammatory nodule count. |
| Secondary | Percentage change in AN count at Week 16 | Baseline to Week 16 | AN count is the total abscess and inflammatory nodule count. |
| Secondary | Percentage of participants achieving HiSCR75 at Week 16 | Week 16 | HiSCR75 is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count. |
| Secondary | Percentage of participants achieving HiSCR90 at Week 16 | Week 16 | HiSCR90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count. |
| Secondary | Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16 | Week 16 | The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease. |
| Secondary | Change in absolute score from Baseline in IHS4 at Week 16 | Baseline to Week 16 | The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease. |
| Secondary | Percentage of participants who experience a flare at Week 16 | Week 16 | A flare is defined as at least a 25% increase in AN count (with a minimum increase of 2 AN) relative to baseline. AN count is the total abscess and inflammatory nodule count. |
| Secondary | Percentage of participants achieving IHS4-55 at Week 16 | Week 16 | IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from baseline. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT06118099
GET https://conductscience.org/api/trials/v1/NCT06118099/registered