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

• Status: Not yet recruiting
• Trial end date: 2025-03-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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 localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin

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