Clinical trial NCT05849922: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Official title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 86
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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
timeFrame: Week 16
Secondary outcomes:
measure: Time to onset of achieving HiSCR50
timeFrame: Up 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 one 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: From Baseline to week 16
measure: Percentage of participants who experience a flare
timeFrame: Week 16
measure: Percentage of participants achieving IHS4-55
timeFrame: Week 16
measure: Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
timeFrame: Up to week 36
measure: 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
timeFrame: Week 16
measure: Serum SAR442970 concentrations throughout the study
timeFrame: Up to 36 weeks
measure: Incidence of anti-SAR442970 antibody positive response throughout the study
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Site Number : 8400007
state: Arizona
city: Ocala
country: United States
facility: Renstar Medical Research Site Number : 8400011
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research Site Number : 8400006
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC Site Number : 8400002
state: Georgia
city: Johnston
country: United States
facility: Clinical Partners, LLC Site Number : 8400010
state: Rhode Island
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP Site Number : 8400003
state: Texas
city: Liverpool
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Westmead
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360003
state: Queensland
city: Carlton
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560001
city: Sint-Lambrechts-Woluwe
country: Belgium
facility: Investigational Site Number : 0560002
city: Barrie
country: Canada
facility: Investigational Site Number : 1240001
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site Number : 1240004
state: Ontario
city: Quebec
country: Canada
facility: Investigational Site Number : 1240007
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: Ostrava - Poruba
country: Czechia
facility: Investigational Site Number : 2030003
city: Praha 10
country: Czechia
facility: Investigational Site Number : 2030001
city: Praha 5 - Motol
country: Czechia
facility: Investigational Site Number : 2030002
city: Roskilde
country: Denmark
facility: Investigational Site Number : 2080001
city: Lyon
country: France
facility: Investigational Site Number : 2500001
city: Nice
country: France
facility: Investigational Site Number : 2500002
city: Reims
country: France
facility: Investigational Site Number : 2500003
city: Saint Mande
country: France
facility: Investigational Site Number : 2500004
city: Berlin
country: Germany
facility: Investigational Site Number : 2760005
city: Bochum
country: Germany
facility: Investigational Site Number : 2760008
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number : 2760002
city: Mainz
country: Germany
facility: Investigational Site Number : 2760004
city: Münster
country: Germany
facility: Investigational Site Number : 2760001
city: Athens
country: Greece
facility: Investigational Site Number : 3000003
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Milano
country: Italy
facility: Investigational Site Number : 3800001
state: Lombardia
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800002
state: Lombardia
city: Catania
country: Italy
facility: Investigational Site Number : 3800003
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280002
city: Groningen
country: Netherlands
facility: Investigational Site Number : 5280001
city: Rotterdam
country: Netherlands
facility: Investigational Site Number : 5280003
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160001
state: Mazowieckie
city: Lodz
country: Poland
facility: Investigational Site Number : 6160004
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160003
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160002
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240003
state: Barcelona [Barcelona]
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Investigational Site Number : 7240006
state: Madrid, Comunidad De
city: Manises
country: Spain
facility: Investigational Site Number : 7240004
state: Valencia
city: Córdoba
country: Spain
facility: Investigational Site Number : 7240005
city: Alvsjo
country: Sweden
facility: Investigational Site Number : 7520001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: