Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06118099
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
90 participants
INTERVENTIONAL
2023-11-01
2025-10-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amlitelimab
Subcutaneous injection (SC) as per protocol.
Amlitelimab
Injection solution SC injection
Placebo
Subcutaneous injection as per protocol.
Placebo
Injection solution SC injection
Interventions
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Amlitelimab
Injection solution SC injection
Placebo
Injection solution SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Investigational Site Number : 2500002
Saint-Mandé, , France
Investigational Site Number : 2760002
Bochum, , Germany
Investigational Site Number : 2760001
Münster, , Germany
Investigational Site Number : 3480004
Budapest, , Hungary
Investigational Site Number : 3480001
Debrecen, , Hungary
Investigational Site Number : 3480002
Szeged, , Hungary
Investigational Site Number : 3800001
Catania, , Italy
Investigational Site Number : 3800002
Cona (Ferrara), , Italy
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160004
Warsaw, , Poland
Investigational Site Number : 6160003
Wroclaw, , Poland
Investigational Site Number : 6200002
Lisbon, , Portugal
Investigational Site Number : 6200001
Lisbon, , Portugal
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Badalona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240006
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad de, Spain
Countries
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Related Links
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ACT17967 Plain Language Results Summary
Other Identifiers
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U1111-1290-9497
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-505803-22
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT17967
Identifier Type: -
Identifier Source: org_study_id