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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

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 Overview

• Status: Terminated
• Conditions: Hidradenitis
• Intervention / Treatment: Drug: Amlitelimab; Drug: Placebo

Detailed Description

The study duration per participant will be up to 116 weeks.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Investigational Site Number : 0360003
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Investigational Site Number : 0360001
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Investigational Site Number : 0360002
• Canada
  • Québec, Canada, G1W 4R4
    • Investigational Site Number : 1240001
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Investigational Site Number : 1240007
    • Hamilton, Ontario, Canada, L8L 3C3
      • Investigational Site Number : 1240002
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
      • Investigational Site Number : 1520002
• France
  • La Rochelle, France, 17019
    • Investigational Site Number : 2500005
  • Lyon, France, 69003
    • Investigational Site Number : 2500003
  • Reims, France, 51100
    • Investigational Site Number : 2500001
  • Rouen, France, 76031
    • Investigational Site Number : 2500004
  • Saint-Mandé, France, 94163
    • Investigational Site Number : 2500002
• Germany
  • Bochum, Germany, 44791
    • Investigational Site Number : 2760002
  • Münster, Germany, 48149
    • Investigational Site Number : 2760001
• Hungary
  • Budapest, Hungary, 1083
    • Investigational Site Number : 3480004
  • Debrecen, Hungary, 4032
    • Investigational Site Number : 3480001
  • Szeged, Hungary, 6720
    • Investigational Site Number : 3480002
• Italy
  • Catania, Italy, 95123
    • Investigational Site Number : 3800001
  • Cona (Ferrara), Italy, 44124
    • Investigational Site Number : 3800002
• Poland
  • Warsaw, Poland, 02-962
    • Investigational Site Number : 6160004
  • Wroclaw, Poland, 50-566
    • Investigational Site Number : 6160003
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Investigational Site Number : 6160001
• Portugal
  • Lisbon, Portugal, 1998-018
    • Investigational Site Number : 6200001
  • Lisbon, Portugal, 1649-035
    • Investigational Site Number : 6200002
• Spain
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08041
      • Investigational Site Number : 7240001
  • Catalunya [Cataluña]
    • Badalona, Catalunya [Cataluña], Spain, 08916
      • Investigational Site Number : 7240003
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Investigational Site Number : 7240006
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Investigational Site Number : 7240002
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006-2754
      • Medical Dermatology Specialists Site Number : 8400002
  • California
    • Fremont, California, United States, 94538-1614
      • Center for Dermatology Clinical Research Site Number : 8400010
  • Florida
    • Margate, Florida, United States, 33063
      • Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011
    • Miami, Florida, United States, 33173
      • Florida International Research Center Site Number : 8400016
    • Tampa, Florida, United States, 33612
      • University of South Florida Site Number : 8400012
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center Site Number : 8400006
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine Site Number : 8400007
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Centricity Research Site Number : 8400009
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC Site Number : 8400003
  • Texas
    • Addison, Texas, United States, 75001
      • Vast Skin Specialists Site Number : 8400015
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP Site Number : 8400001
    • Southlake, Texas, United States, 76092
      • Stryde Research Epiphany Dermatology Site Number : 8400014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlitelimab; Subcutaneous injection (SC) as per protocol.	Drug: Amlitelimab; Injection solution SC injection; Other Names: SAR445229
Placebo Comparator: Placebo; Subcutaneous injection as per protocol.	Drug: Placebo; Injection solution SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16	Hidradenitis suppurativa clinical response (HiSCR)50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of achieving HiSCR50	HiSCR50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.	From baseline to Week 16
Absolute change from baseline in AN count at Week 16	AN count is the total abscess and inflammatory nodule count.	Baseline to Week 16
Percentage change in AN count at Week 16	AN count is the total abscess and inflammatory nodule count.	Baseline to Week 16
Percentage of participants achieving HiSCR75 at Week 16	HiSCR75 is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.	Week 16
Percentage of participants achieving HiSCR90 at Week 16	HiSCR90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.	Week 16
Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16	The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.	Week 16
Change in absolute score from Baseline in IHS4 at Week 16	The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.	Baseline to Week 16
Percentage of participants who experience a flare at Week 16	A flare is defined as at least a 25% increase in AN count (with a minimum increase of 2 AN) relative to baseline. AN count is the total abscess and inflammatory nodule count.	Week 16
Percentage of participants achieving IHS4-55 at Week 16	IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from baseline. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.	Week 16
Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3	Hidradenitis Suppurativa-Skin pain-numeric rating scale (HS-Skin pain NRS) is scored on a 0 to 10 scale with 0 indicating "no skin pain" and 10 indicating "worst skin pain possible".	Week 16
Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4	PP-NRS is a validated single item 0 (no itch) to10 (worst itch imaginable) numeric rating scale assessing peak pruritus (itch).	Week 16
Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4	Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL). Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Week 16
Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16	HiSQOL is an instrument designed to measure the HS-specific health-related QoL of adults with HS.	Baseline to Week 16
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population		Baseline up to Week 116
Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population		Baseline up to Week 116
Serum amlitelimab concentrations measured at prespecified time points in the PK population		Day 1 up to Week 116
Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population		Day 1 up to Week 116

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• ACT17967 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Sweat Gland Diseases; Skin and Connective Tissue Diseases; Hidradenitis
• Other Study ID Numbers: ACT17967 (Sanofi Identifier); U1111-1290-9497 (Registry Identifier: ICTRP); 2023-505803-22 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No