Clinical trial NCT06118099: Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hidradenitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Time to onset of achieving HiSCR50
timeFrame: From baseline to Week 16
measure: Absolute change from baseline in AN count at Week 16
timeFrame: Baseline to Week 16
measure: Percentage change in AN count at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of participants achieving HiSCR75 at Week 16
timeFrame: Week 16
measure: Percentage of participants achieving HiSCR90 at Week 16
timeFrame: Week 16
measure: Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
timeFrame: Week 16
measure: Change in absolute score from Baseline in IHS4 at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of participants who experience a flare at Week 16
timeFrame: Week 16
measure: Percentage of participants achieving IHS4-55 at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4
timeFrame: Week 16
measure: Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline up to Week 116
measure: Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
timeFrame: Baseline up to Week 116
measure: Serum amlitelimab concentrations measured at prespecified time points in the PK population
timeFrame: Day 1 up to Week 116
measure: Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population
timeFrame: Day 1 up to Week 116
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Site Number : 8400002
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research Site Number : 8400010
state: California
city: Margate
country: United States
facility: Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011
state: Florida
city: Miami
country: United States
facility: Florida International Research Center Site Number : 8400016
state: Florida
city: Tampa
country: United States
facility: University of South Florida Site Number : 8400012
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center Site Number : 8400006
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine Site Number : 8400007
state: Missouri
city: Dublin
country: United States
facility: Centricity Research Site Number : 8400009
state: Ohio
city: Johnston
country: United States
facility: Clinical Partners, LLC Site Number : 8400003
state: Rhode Island
city: Addison
country: United States
facility: Vast Skin Specialists Site Number : 8400015
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP Site Number : 8400001
state: Texas
city: Southlake
country: United States
facility: Stryde Research Epiphany Dermatology Site Number : 8400014
state: Texas
city: Phillip
country: Australia
facility: Investigational Site Number : 0360003
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Barrie
country: Canada
facility: Investigational Site Number : 1240007
state: Ontario
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Quebec
country: Canada
facility: Investigational Site Number : 1240001
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: La Rochelle
country: France
facility: Investigational Site Number : 2500005
city: Lyon
country: France
facility: Investigational Site Number : 2500003
city: Reims
country: France
facility: Investigational Site Number : 2500001
city: Rouen
country: France
facility: Investigational Site Number : 2500004
city: Saint Mande
country: France
facility: Investigational Site Number : 2500002
city: Bochum
country: Germany
facility: Investigational Site Number : 2760002
city: Münster
country: Germany
facility: Investigational Site Number : 2760001
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480004
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3480001
city: Szeged
country: Hungary
facility: Investigational Site Number : 3480002
city: Catania
country: Italy
facility: Investigational Site Number : 3800001
city: Cona (Ferrara)
country: Italy
facility: Investigational Site Number : 3800002
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160001
state: Mazowieckie
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160004
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160003
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200002
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200001
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Badalona
country: Spain
facility: Investigational Site Number : 7240003
state: Catalunya [Cataluña]
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240006
state: Las Palmas
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
state: Madrid, Comunidad De
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: