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A clinical study of tulisokibart in people with hidradenitis suppurativa (MK-7240-012)
EU CTIS ID: 2024-520039-33-00
What this study is testing
1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving HiSCR50 at Week 16
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 systemic antibiotics for treatment of HS
- Has ≤20 draining tunnel count at Screening and Randomization
You likely can't join if
- Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
- 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
- Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
See the full eligibility 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 systemic antibiotics for treatment of HS
- Has ≤20 draining tunnel count at Screening and Randomization
- Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Argentina
- Canada
- Turkey
- Australia
- United Kingdom
- Japan
- China
- United States
- Colombia
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Argentina; Canada; Turkey; Australia; United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.