Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
Has ≤20 draining tunnel count at Screening and Randomization
You may not be if
Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
Has a transplanted organ and requires continued systemic immunosuppression
Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years
Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Has any active infection
Has active tuberculosis
Has had major surgery within the past 3 months or has a major surgery planned during the study
Has a history of clinically significant drug or alcohol abuse within the past 6 months
Has prior exposure to tulisokibart
Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study
Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
