A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

Ki vehet részt

• Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline
• Participants had to 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 had to be Hurley Stage II or Hurley Stage III
• Participant had to 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 had a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history
• Participants had to be either biologic and small molecule immunosuppressive-naïve or TNF-experienced
• Participant had to have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit
• Participant had to have a draining tunnel count of ≤20 at the Baseline visit
• Participant had to have a C-reactive protein (CRP) >3 mg/L at the screening visit
• Participant who was a candidate for systemic treatment per Investigator's judgment

Ki nem vehet részt

• Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
• History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
• Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that might have interfered 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
• 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 had a lifetime history of suicide attempt, or participant had 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
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicated participation in the study
• A history of an adverse event (AE) to anti-TNF therapy (examples included, but were not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
• Laboratory exclusion criteria applied; The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
• Female participants who were breastfeeding or considering becoming pregnant during the study