Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Study of Investigational Medication for Moderate to Severe 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 given through subcutaneous injection in adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to compare the investigational medication to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine, to understand its efficacy, safety, and biological effects.
Participants will receive either the investigational medication or a placebo in a randomized, double-blind manner, meaning neither the participants nor the researchers will know who receives the actual medication. The study will measure outcomes reported by clinicians and participants, as well as drug concentration in the body. An optional long-term extension period will be available to assess the safety and efficacy of the medication over a longer period.
- Who can participate: Adults aged 18 to 70 who have had hidradenitis suppurativa for at least one year may participate. They must have lesions in at least two distinct areas of the body and have previously not responded adequately to a 12-week trial of oral antibiotics.
- Study details: Participants will receive injections of either the investigational medication or a placebo. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine. The study includes a period where participants will be monitored for safety and effectiveness of the treatment. Participants who complete the initial treatment period may choose to continue in a long-term extension study to further evaluate the medication's safety and efficacy.
- Study timelines and visits: The study will last 116 weeks. The study requires 6 visits.
