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Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.
Study details include: * The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period. * All participants who complete the 16-week DBT period will be offered entry into an optional LTE. * Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
* The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
Study details:
The study duration per participant will be up to 116 weeks.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-11-01
Primary completion: 2025-03-13
Study completion finish: 2027-01-14
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06118099
Intervention or treatment
DRUG: Amlitelimab
DRUG: Placebo
Conditions
- • Hidradenitis
Find a site
Closest Location:
Investigational Site Number : 0360003
Research sites nearby
Select from list below to view details:
Investigational Site Number : 0360003
Phillip, Australian Capital Territory, Australia
Investigational Site Number : 0360001
Darlinghurst, New South Wales, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Amlitelimab
| DRUG: Amlitelimab
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| The clinical response as measured by the percentage of participants achieving HiSCR50 at 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. | Week 16 |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Time to onset of achieving HiSCR50 | 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. | From baseline to Week 16 |
| Absolute change from baseline in AN count at Week 16 | AN count is the total abscess and inflammatory nodule count. | Baseline to Week 16 |
| Percentage change in AN count at Week 16 | AN count is the total abscess and inflammatory nodule count. | Baseline to Week 16 |
| Percentage of participants achieving HiSCR75 at 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. | Week 16 |
| Percentage of participants achieving HiSCR90 at 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. | Week 16 |
| Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at 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. | Week 16 |
| Change in absolute score from Baseline in IHS4 at 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. | Baseline to Week 16 |
| Percentage of participants who experience a flare at 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. | Week 16 |
| Percentage of participants achieving IHS4-55 at 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. | Week 16 |
| 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 | 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". | Week 16 |
| 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 | PP-NRS is a validated single item 0 (no itch) to10 (worst itch imaginable) numeric rating scale assessing peak pruritus (itch). | Week 16 |
| Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4 | 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. | Week 16 |
| Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16 | HiSQOL is an instrument designed to measure the HS-specific health-related QoL of adults with HS. | Baseline to Week 16 |
| 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 | Not Specified | Baseline up to Week 116 |
| Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population | Not Specified | Baseline up to Week 116 |
| Serum amlitelimab concentrations measured at prespecified time points in the PK population | Not Specified | Day 1 up to Week 116 |
| Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population | Not Specified | Day 1 up to Week 116 |
Frequently Asked Questions
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