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

Phase 2TerminatedNCT06118099

Sanofi90 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (42)

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

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline to Week 16

Percentage change in AN count at Week 16

AN count is the total abscess and inflammatory nodule count.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Baseline up to Week 116

Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population

Time frame: Baseline up to Week 116

Serum amlitelimab concentrations measured at prespecified time points in the PK population

Time frame: Day 1 up to Week 116

Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population

Time frame: Day 1 up to Week 116

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

Overview

Conditions

Interventions

Eligibility

Locations (42)

Outcomes

Primary Outcomes

Secondary Outcomes