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

Hidradenitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118099
• Other study ID #: ACT17967
• Secondary ID: U1111-1290-94972
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: January 14, 2027

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 14, 2027
• Est. primary completion date: March 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Amlitelimab
Injection solution SC injection
• Placebo
Injection solution SC injection

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360001	Darlinghurst	New South Wales
Australia	Investigational Site Number : 0360002	Melbourne	Victoria
Canada	Investigational Site Number : 1240007	Barrie	Ontario
Canada	Investigational Site Number : 1240002	Hamilton	Ontario
Canada	Investigational Site Number : 1240001	Quebec
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Hungary	Investigational Site Number : 3480004	Budapest
Italy	Investigational Site Number : 3800002	Cona (Ferrara)
Portugal	Investigational Site Number : 6200001	Lisboa
Portugal	Investigational Site Number : 6200002	Lisboa
United States	Centricity Research Site Number : 8400009	Dublin	Ohio
United States	Center for Dermatology Clinical Research Site Number : 8400010	Fremont	California
United States	Center for Clinical Studies, LTD. LLP Site Number : 8400001	Houston	Texas
United States	Clinical Partners, LLC Site Number : 8400003	Johnston	Rhode Island
United States	Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011	Margate	Florida
United States	Medical Dermatology Specialists Site Number : 8400002	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Hungary,  Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Absolute change from baseline in AN count at Week 16	AN count is the total abscess and inflammatory nodule count.	Baseline to Week 16
Secondary	Percentage change in AN count at Week 16	AN count is the total abscess and inflammatory nodule count.	Baseline to Week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population		Baseline up to Week 116
Secondary	Serum amlitelimab concentrations measured at prespecified time points in the PK population		Day 1 up to Week 116
Secondary	Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population		Day 1 up to Week 116