Trial · NCT06118099
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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. |
| Secondary | Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3 | Week 16 | Hidradenitis Suppurativa-Skin pain-numeric rating scale (HS-Skin pain NRS) is scored on a 0 to 10 scale with 0 indicating "no skin pain" and 10 indicating "worst skin pain possible". |
| Secondary | Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4 | Week 16 | PP-NRS is a validated single item 0 (no itch) to10 (worst itch imaginable) numeric rating scale assessing peak pruritus (itch). |
| Secondary | Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4 | Week 16 | Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL). Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. |
| Secondary | Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16 | Baseline to Week 16 | HiSQOL is an instrument designed to measure the HS-specific health-related QoL of adults with HS. |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population | Baseline up to Week 116 | |
| Secondary | Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population | Baseline up to Week 116 | |
| Secondary | Serum amlitelimab concentrations measured at prespecified time points in the PK population | Day 1 up to Week 116 | |
| Secondary | Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population | Day 1 up to Week 116 |
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
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