A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
- Registration Number
- NCT05849922
- Lead Sponsor
- Sanofi
- Brief Summary
This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
- Detailed Description
The study duration will be up to 40 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (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 inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, 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 must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
- Participant must have a draining tunnel count of ≤20 at the Baseline visit.
- Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit.
- Participant who is a candidate for systemic treatment per Investigator's judgment.
- 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 significant current immunosuppression
- History of solid organ transplant
- History of splenectomy
- History of moderate to severe congestive heart failure
- Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- Participants with a diagnosis of inflammatory conditions other than HS
- Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
- A history of an adverse event (AE) to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Female participants who are breastfeeding or considering becoming pregnant during the study
- History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- Laboratory exclusion criteria apply
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR442970 SAR442970 Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28). Placebo Placebo Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).
- Primary Outcome Measures
Name Time Method Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) Week 16 HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count
- Secondary Outcome Measures
Name Time Method Time to onset of achieving HiSCR50 Up to week 16 Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions Up to week 36 Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-SkinPainNRS) at Week 16 among participants with Baseline NRS ≥3 Week 16 Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period)
Change in absolute score from Baseline in IHS4 at week 16 From Baseline to week 16 Serum SAR442970 concentrations throughout the study Up to 36 weeks Percentage of participants who experience a flare Week 16 Flare is defined as at least 25% increase in the total abscess and inflammatory nodule \[AN\] count (with a minimum increase of 2) relative to Baseline at week 16.
Percentage of participants achieving IHS4-55 Week 16 IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
Incidence of anti-SAR442970 antibody positive response throughout the study Up to 36 weeks Percentage of participants achieving HiSCR75 at Week 16 Week 16 HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count
Percentage of participants achieving HiSCR90 at week 16 Week 16 HiSCR90 is defined as at least a 90% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count
Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16 Week 16 The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
Trial Locations
- Locations (50)
Center for Clinical Studies, LTD. LLP Site Number : 8400003
🇺🇸Houston, Texas, United States
Investigational Site Number : 0360002
🇦🇺Liverpool, New South Wales, Australia
Investigational Site Number : 2500004
🇫🇷Saint Mande, France
Investigational Site Number : 3800002
🇮🇹Rozzano, Lombardia, Italy
Investigational Site Number : 7240004
🇪🇸Manises, Valencia, Spain
Investigational Site Number : 2500002
🇫🇷Nice, France
Medical Dermatology Specialists Site Number : 8400007
🇺🇸Phoenix, Arizona, United States
Renstar Medical Research Site Number : 8400011
🇺🇸Ocala, Florida, United States
ForCare Clinical Research Site Number : 8400006
🇺🇸Tampa, Florida, United States
Advanced Medical Research PC Site Number : 8400002
🇺🇸Sandy Springs, Georgia, United States
Clinical Partners, LLC Site Number : 8400010
🇺🇸Johnston, Rhode Island, United States
Investigational Site Number : 0360005
🇦🇺Westmead, New South Wales, Australia
Investigational Site Number : 0360001
🇦🇺Carlton, Victoria, Australia
Investigational Site Number : 0360003
🇦🇺Woolloongabba, Queensland, Australia
Investigational Site Number : 0560002
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Investigational Site Number : 0560001
🇧🇪Leuven, Belgium
Investigational Site Number : 1240004
🇨🇦Newmarket, Ontario, Canada
Investigational Site Number : 1240007
🇨🇦Quebec, Canada
Investigational Site Number : 1240001
🇨🇦Barrie, Ontario, Canada
Investigational Site Number : 1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1240002
🇨🇦London, Ontario, Canada
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 2030001
🇨🇿Praha 10, Czechia
Investigational Site Number : 2030003
🇨🇿Ostrava - Poruba, Czechia
Investigational Site Number : 2030002
🇨🇿Praha 5 - Motol, Czechia
Investigational Site Number : 2500003
🇫🇷Reims, France
Investigational Site Number : 2500001
🇫🇷Lyon, France
Investigational Site Number : 2080001
🇩🇰Roskilde, Denmark
Investigational Site Number : 2760005
🇩🇪Berlin, Germany
Investigational Site Number : 2760008
🇩🇪Bochum, Germany
Investigational Site Number : 2760001
🇩🇪Münster, Germany
Investigational Site Number : 2760004
🇩🇪Mainz, Germany
Investigational Site Number : 3000003
🇬🇷Athens, Greece
Investigational Site Number : 3000001
🇬🇷Athens, Greece
Investigational Site Number : 3800001
🇮🇹Milano, Lombardia, Italy
Investigational Site Number : 3800003
🇮🇹Catania, Italy
Investigational Site Number : 5280002
🇳🇱Breda, Netherlands
Investigational Site Number : 2760002
🇩🇪Frankfurt am Main, Germany
Investigational Site Number : 5280001
🇳🇱Groningen, Netherlands
Investigational Site Number : 5280003
🇳🇱Rotterdam, Netherlands
Investigational Site Number : 6160001
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site Number : 6160004
🇵🇱Lodz, Poland
Investigational Site Number : 6160003
🇵🇱Wroclaw, Poland
Investigational Site Number : 7240001
🇪🇸Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240003
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 6160002
🇵🇱Wroclaw, Poland
Investigational Site Number : 7520001
🇸🇪Alvsjo, Sweden
Investigational Site Number : 7240005
🇪🇸Córdoba, Spain