Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT06956235
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06956235
Study Brief:
Protocol Section:
NCT06956235