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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis

In brief

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.

Key facts

Study ID

NCT06118099

Run by

Sanofi

People needed

90

Starts

2023-11-01

Expected to finish

2025-10-10

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Dermatology Specialists Site Number : 8400002 — Phoenix, Arizona, United States
• Center for Dermatology Clinical Research Site Number : 8400010 — Fremont, California, United States
• Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011 — Margate, Florida, United States
• Florida International Research Center Site Number : 8400016 — Miami, Florida, United States
• University of South Florida Site Number : 8400012 — Tampa, Florida, United States
• Beth Israel Deaconess Medical Center Site Number : 8400006 — Boston, Massachusetts, United States
• Washington University School of Medicine Site Number : 8400007 — St Louis, Missouri, United States
• Centricity Research Site Number : 8400009 — Dublin, Ohio, United States
• Clinical Partners, LLC Site Number : 8400003 — Johnston, Rhode Island, United States
• Vast Skin Specialists Site Number : 8400015 — Addison, Texas, United States
• Center for Clinical Studies, LTD. LLP Site Number : 8400001 — Houston, Texas, United States
• Stryde Research Epiphany Dermatology Site Number : 8400014 — Southlake, Texas, United States
• 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
• Investigational Site Number : 1240007 — Barrie, Ontario, Canada
• Investigational Site Number : 1240002 — Hamilton, Ontario, Canada
• Investigational Site Number : 1240001 — Québec, Canada
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520002 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 2500005 — La Rochelle, France
• Investigational Site Number : 2500003 — Lyon, France
• Investigational Site Number : 2500001 — Reims, France
• Investigational Site Number : 2500004 — Rouen, France

Full record on ClinicalTrials.gov

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