Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Study on Investigational Medication for Hidradenitis Suppurativa
Study Overview
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
You may be eligible for this study if you meet the following criteria:
- Conditions: Hidradenitis
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Age: 18 years - 70 years
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Gender: All
Inclusion Criteria:
- Participant must be 18 (or country's age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
Exclusion Criteria:
- Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
This study investigates the effects of an investigational medication compared to a placebo in people with moderate to severe hidradenitis suppurativa (HS). HS is a chronic skin condition that causes small, painful lumps under the skin. The purpose of this study is to understand the medication's effects on clinician-reported and participant-reported outcomes, safety, and drug concentration.
Participants will receive subcutaneous injections and be randomly assigned to either the investigational medication or placebo. The study includes a double-blind treatment period where neither participants nor doctors know who receives the medication or placebo. Participants who complete the initial phase can join an optional long-term extension to assess ongoing safety and effectiveness.
- Who can participate: Adults aged 18 to 70 years with a history of hidradenitis suppurativa for at least one year may participate. They must have HS lesions in at least two different areas and have not responded well to a 12-week oral antibiotic treatment. Individuals with other inflammatory conditions or active skin diseases are not eligible.
- Study details: Participants will receive injections and may be asked to attend clinic visits. Some may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will assess various outcomes related to HS.
- Study timelines and visits: The study will last up to 116 weeks. The study requires up to 16 visits.
