Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Testing a Treatment for Hidradenitis Suppurativa

Recruiting
18 years - 70 years
All
Phase 2
84 participants needed
7 Locations

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
  • Age: 18 years - 70 years
  • 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

Updated on 03 Jun 2024. Study ID: NCT06118099

This study investigates the effects of an investigational medication given by injection compared to a placebo in adults with moderate to severe hidradenitis suppurativa (HS). Hidradenitis suppurativa is a chronic skin condition that causes small, painful lumps under the skin that can break open and form tunnels. The study aims to understand how safe and effective the treatment is, how the body processes the medication, and the biological effects it has on the condition.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will measure outcomes reported by doctors and participants, as well as check the safety and concentration of the drug in the body. There is an optional long-term extension period to further evaluate the effects of the treatment.

  • Who can participate: Adults aged 18 to 70 years with moderate to severe hidradenitis suppurativa are eligible. Participants must have had HS symptoms for at least a year and have lesions in at least two different areas. They should have tried an oral antibiotic for at least 12 weeks without sufficient improvement.
  • Study details: Participants will receive injections of either the investigational medication or a placebo. The study will track how the treatment affects their condition and the safety of the medication. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study Timelines and Visits: The study will last up to 116 weeks. The study requires up to 16 visits.

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