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

NCT06118099 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: ACT17967U1111-1290-94972023-505803-22
• Study Type: interventional
• Target: 90
• Locations: 11 countries
• Sites: 42

Brief Summary

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.

Conditions

Hidradenitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Time to onset of achieving HiSCR50

  From baseline to Week 16

• Absolute change from baseline in AN count at Week 16

  Baseline to Week 16

• Percentage change in AN count at Week 16

  Baseline to Week 16

• Percentage of participants achieving HiSCR75 at Week 16

  Week 16

• Percentage of participants achieving HiSCR90 at Week 16

  Week 16

Study Arms (2)

Amlitelimab

EXPERIMENTAL

Subcutaneous injection (SC) as per protocol.

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol.

Drug: Placebo

Interventions

Amlitelimab DRUG

Injection solution SC injection

Also known as: SAR445229

Amlitelimab

Placebo DRUG

Injection solution SC injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (42)

Medical Dermatology Specialists Site Number : 8400002

Phoenix, Arizona, 85006-2754, United States

Location

Center for Dermatology Clinical Research Site Number : 8400010

Fremont, California, 94538-1614, United States

Location

Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011

Margate, Florida, 33063, United States

Location

Florida International Research Center Site Number : 8400016

Miami, Florida, 33173, United States

Location

University of South Florida Site Number : 8400012

Tampa, Florida, 33612, United States

Location

Beth Israel Deaconess Medical Center Site Number : 8400006

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine Site Number : 8400007

St Louis, Missouri, 63110, United States

Location

Centricity Research Site Number : 8400009

Dublin, Ohio, 43016, United States

Location

Clinical Partners, LLC Site Number : 8400003

Johnston, Rhode Island, 02919, United States

Location

Vast Skin Specialists Site Number : 8400015

Addison, Texas, 75001, United States

Location

Center for Clinical Studies, LTD. LLP Site Number : 8400001

Houston, Texas, 77004, United States

Location

Stryde Research Epiphany Dermatology Site Number : 8400014

Southlake, Texas, 76092, United States

Location

Investigational Site Number : 0360003

Phillip, Australian Capital Territory, 2606, Australia

Location

Investigational Site Number : 0360001

Darlinghurst, New South Wales, 2010, Australia

Location

Investigational Site Number : 0360002

Melbourne, Victoria, 3004, Australia

Location

Investigational Site Number : 1240007

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site Number : 1240002

Hamilton, Ontario, L8L 3C3, Canada

Location

Investigational Site Number : 1240001

Québec, G1W 4R4, Canada

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 2500005

La Rochelle, 17019, France

Location

Investigational Site Number : 2500003

Lyon, 69003, France

Location

Investigational Site Number : 2500001

Reims, 51100, France

Location

Investigational Site Number : 2500004

Rouen, 76031, France

Location

Investigational Site Number : 2500002

Saint-Mandé, 94163, France

Location

Investigational Site Number : 2760002

Bochum, 44791, Germany

Location

Investigational Site Number : 2760001

Münster, 48149, Germany

Location

Investigational Site Number : 3480004

Budapest, 1083, Hungary

Location

Investigational Site Number : 3480001

Debrecen, 4032, Hungary

Location

Investigational Site Number : 3480002

Szeged, 6720, Hungary

Location

Investigational Site Number : 3800001

Catania, 95123, Italy

Location

Investigational Site Number : 3800002

Cona (Ferrara), 44124, Italy

Location

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Investigational Site Number : 6160004

Warsaw, 02-962, Poland

Location

Investigational Site Number : 6160003

Wroclaw, 50-566, Poland

Location

Investigational Site Number : 6200002

Lisbon, 1649-035, Portugal

Location

Investigational Site Number : 6200001

Lisbon, 1998-018, Portugal

Location

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08041, Spain

Location

Investigational Site Number : 7240003

Badalona, Catalunya [Cataluña], 08916, Spain

Location

Investigational Site Number : 7240006

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Investigational Site Number : 7240002

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Related Links

• ACT17967 Plain Language Results Summary

MeSH Terms

Conditions

Hidradenitis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: February 6, 2025
• Study Completion: October 10, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

PT (2); DE (2); HU (3); PL (3); US (12); IT (2); CL (3); ES (4); AU (3); CA (3); FR (5)