Last updated 25 days ago
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
188 patients around the world
Available in Chile, United States
Sanofi
188Patients around the world
This study is for people with
Hidradenitis suppurativa
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline.Participants must have HS lesions present in at least 2 distinct anatomic areas, 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-naive or biologic-experienced.Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.Participant must have a draining tunnel count of ≤20 at the Baseline visit.
- Any other active skin disease or condition that may interfere with assessment of HS.History of recurrent or recent serious infection.Known history of significant immunosuppression.History of solid organ transplant or stem cell transplant.History of splenectomy.History of moderate to severe congestive heart failure.History of demyelinating disease 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 of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol.Active suicidality and therefore significant suicide risk, as judged by the Investigator.A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy 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.History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
StudyBRIGHTEN
SponsorSanofi
Study typeInterventional
Conditions
Hidradenitis suppurativa
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07170917
