A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Official title

A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa

Overview

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

Interventions

• Drug SAR445399
  Pharmaceutical form: Solution for injection -Route of administration: Injection
• Drug Placebo
  Pharmaceutical form: Solution for injection -Route of administration: Injection

Primary outcome measures

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time frame: Up to Week 16]

Secondary outcome measures (12)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time frame: Up to Week 16]
• Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4) [Time frame: From baseline to Week 16]
• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [Time frame: Up to Week 16]
• Percent change from baseline to Week 16 in draining tunnel count [Time frame: From Baseline to week 16]
• Absolute change from baseline to Week 16 in draining tunnel count [Time frame: From Baseline to week 16]
• Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3 [Time frame: From baseline to Week 16]
• Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) [Time frame: From Baseline to Week 16]
• Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score [Time frame: From Baseline to Week 16]
• Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score [Time frame: From Baseline to Week 16]
• Change from baseline to Week 16 in Weekly average HS-SAQ score items [Time frame: From Baseline to Week 16]
• Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score [Time frame: From Baseline to Week 16]
• Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16 [Time frame: From Baseline to Week 16]

Eligibility criteria

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months 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), with at least 1 body site being Hurley Stage II or III.
• Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
• Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
• Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
• History of recurrent or recent serious infection
• Known history of or suspected current immunosuppression
• History of solid organ transplant or stem cell transplant.
• History of splenectomy
• History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
• Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 16 centers

• Scottsdale Clinical Trials- Site Number : 8400006 — Scottsdale
• Carbon Health - North Hollywood - NoHo West- Site Number : 8400017 — North Hollywood
• Encore Medical Research of Boynton Beach- Site Number : 8400005 — Boynton Beach
• FXM Clinical Research - Fort Lauderdale- Site Number : 8400013 — Fort Lauderdale
• Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007 — Fort Myers
• Encore Medical Research - Hollywood- Site Number : 8400004 — Hollywood
• Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014 — Miami
• Florida International Research Center- Site Number : 8400002 — Miami
• … and 8 more centers

Turkey (Türkiye) · 6 centers

• Investigational Site Number : 7920006 — Buca
• Investigational Site Number : 7920001 — Istanbul
• Investigational Site Number : 7920005 — Istanbul
• Investigational Site Number : 7920004 — Izmir
• Investigational Site Number : 7920002 — Manisa
• Investigational Site Number : 7920003 — Samsun

Canada · 5 centers

• Investigational Site Number : 1240014 — Toronto
• Investigational Site Number : 1240010 — Montreal
• Investigational Site Number : 1240002 — Sherbrooke
• Investigational Site Number : 1240013 — Regina
• Investigational Site Number : 1240011 — Saskatoon

France · 5 centers

• Investigational Site Number : 2500005 — Lille
• Investigational Site Number : 2500006 — Lille
• Investigational Site Number : 2500002 — Nantes
• Investigational Site Number : 2500004 — Paris
• Investigational Site Number : 2500003 — Rouen

Germany · 5 centers

• Investigational Site Number : 2760004 — Blankenfelde-Mahlow
• Investigational Site Number : 2760007 — Darmstadt
• Investigational Site Number : 2760005 — Merzig
• Investigational Site Number : 2760003 — Regensburg
• Investigational Site Number : 2760002 — Rostock

Italy · 5 centers

• Investigational Site Number : 3800002 — Torette
• Investigational Site Number : 3800005 — Cona
• Investigational Site Number : 3800003 — Milan
• Investigational Site Number : 3800004 — Brescia
• Investigational Site Number : 3800001 — Chieti

Spain · 5 centers

• Investigational Site Number : 7240006 — Barcelona
• Investigational Site Number : 7240002 — Bilbao
• Investigational Site Number : 7240005 — Seville
• Investigational Site Number : 7240001 — Córdoba
• Investigational Site Number : 7240004 — Málaga

China · 4 centers

• Investigational Site Number : 1560001 — Beijing
• Investigational Site Number : 1560003 — Changsha
• Investigational Site Number : 1560004 — Shanghai
• Investigational Site Number : 1560002 — Wuhan

Hungary · 4 centers

• Investigational Site Number : 3480002 — Budapest
• Investigational Site Number : 3480005 — Gyula
• Investigational Site Number : 3480003 — Kaposvár
• Investigational Site Number : 3480004 — Szeged

Belgium · 3 centers

• Investigational Site Number : 0560002 — Brussels
• Investigational Site Number : 0560001 — Ghent
• Investigational Site Number : 0560004 — Liège

Argentina · 2 centers

• Investigational Site Number : 0320001 — Buenos Aires
• Investigational Site Number : 0320002 — Buenos Aires

Japan · 2 centers

• Investigational Site Number : 3920002 — Tokyo
• Investigational Site Number : 3920001 — Tokyo

Sweden · 2 centers

• Investigational Site Number : 7520001 — Örebro
• Investigational Site Number : 7520002 — Uppsala

Australia · 1 center

• Investigational Site Number : 0360001 — Sydney

Brazil · 1 center

• Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 — Salvador

Identifiers

NCT: NCT07225569 · DRI20674 · 2025-522695-83-00 · U1111-1322-6148

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗